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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_1 | Pages 122 - 122
1 Jan 2016
Emoto G
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BACKGROUND. The aim of Patient-specific instrumentation surgery is to improve accuracy and limit the range of surgical variability. The main purpose of this study is to summarize and compare the radiographic outcomes of TKA performed using Patient-specific instrumentation compared with conventional techniques. PURPOSES. In this study, we compared varus/valgus of the individual prosthesis components, rotation of femoral components and posterior slope of tibial components of 40 TKAs performed using a patient-specific technique with values from a matched control group of patients who were operated on by conventional intramedullary alignment technique. METHODS. We retrospectively evaluated 55 primary TKAs performed for osteoarthritis: conventional instrumentation using the PFC Sigma (n = 15) patient-specific instrumentation using GMK MyKnee© (n = 40). Varus/valgus of the individual prosthesis components, rotation of femoral components and posterior slope of tibial components were measured from CT images taken post operation, whether there were more outliers with one of the two methods. The fraction of outliers (> 3°) was determined. RESULTS. There was excellent reliability with low standard deviations for the determination of femoral component rotation and varus/valgus of the tibial components. There were significantly more outliers in the conventional (26.7%) group than in the patient-specific instrument group (10.0%). Outliers in Varus/valgus of femoral components were comparable between groups (7.5% in the patient-specific instrument group and 6.7% in the conventional instrument group). Other parameters such as posterior slope of tibial components did not differ in terms of outliers. CONCLUSIONS. In this study, Patient-specific instrument was effective in significantly reducing outliers of rotational femoral component and varus/valgus of the tibial components alignment during TKA. Therefore, additional studies are needed to determine whether patient-specific instrumentation improves clinical function or patient satisfaction


Aims. Patient-specific instrumentation of total knee arthroplasty (TKA) is a technique permitting the targeting of individual kinematic alignment, but deviation from a neutral mechanical axis may have implications on implant fixation and therefore survivorship. The primary objective of this randomized controlled study was to compare the fixation of tibial components implanted with patient-specific instrumentation targeting kinematic alignment (KA+PSI) versus components placed using computer-assisted surgery targeting neutral mechanical alignment (MA+CAS). Tibial component migration measured by radiostereometric analysis was the primary outcome measure (compared longitudinally between groups and to published acceptable thresholds). Secondary outcome measures were inducible displacement after one year and patient-reported outcome measures (PROMS) over two years. The secondary objective was to assess the relationship between alignment and both tibial component migration and inducible displacement. Patients and Methods. A total of 47 patients due to undergo TKA were randomized to KA+PSI (n = 24) or MA+CAS (n = 23). In the KA+PSI group, there were 16 female and eight male patients with a mean age of 64 years (. sd. 8). In the MA+CAS group, there were 17 female and six male patients with a mean age of 63 years (. sd. 7). Surgery was performed using cemented, cruciate-retaining Triathlon total knees with patellar resurfacing, and patients were followed up for two years. The effect of alignment on tibial component migration and inducible displacement was analyzed irrespective of study group. Results. There was no difference over two years in longitudinal migration of the tibial component between the KA+PSI and MA+CAS groups (reaching median maximum total point motion migration at two years of 0.40 mm for the KA+PSI group and 0.37 mm for the MA+CAS group, p = 0.82; p = 0.68 adjusted for age, sex, and body mass index (BMI) for all follow-ups). Both groups had mean migrations below acceptable thresholds. There was no difference in inducible displacement (p = 0.34) or PROMS (p = 0.61 for the Oxford Knee Score) between groups. There was no correlation between alignment and tibial component migration or alignment and inducible displacement. These findings support non-neutral alignment as a viable option with this component, with no evidence that it compromises fixation. Conclusion. Kinematic alignment using patient-specific instrumentation in TKA was associated with acceptable tibial component migration, indicating stable fixation. These results are supportive of future investigations of kinematic alignment. Cite this article: Bone Joint J 2019;101-B:929–940


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 565 - 572
1 May 2019
Teeter MG Marsh JD Howard JL Yuan X Vasarhelyi EM McCalden RW Naudie DDR

Aims. The purpose of the present study was to compare patient-specific instrumentation (PSI) and conventional surgical instrumentation (CSI) for total knee arthroplasty (TKA) in terms of early implant migration, alignment, surgical resources, patient outcomes, and costs. . Patients and Methods. The study was a prospective, randomized controlled trial of 50 patients undergoing TKA. There were 25 patients in each of the PSI and CSI groups. There were 12 male patients in the PSI group and seven male patients in the CSI group. The patients had a mean age of 69.0 years (. sd. 8.4) in the PSI group and 69.4 years (. sd. 8.4) in the CSI group. All patients received the same TKA implant. Intraoperative surgical resources and any surgical waste generated were recorded. Patients underwent radiostereometric analysis (RSA) studies to measure femoral and tibial component migration over two years. Outcome measures were recorded pre- and postoperatively. Overall costs were calculated for each group. Results. There were no differences (p > 0.05) in any measurement of migration at two years for either the tibial or femoral components. Movement between one and two years was < 0.2 mm, indicating stable fixation. There were no differences in coronal or sagittal alignment between the two groups. The PSI group took a mean 6.1 minutes longer (p = 0.04) and used a mean 3.4 less trays (p < 0.0001). Total waste generated was similar (10 kg) between the two groups. The PSI group cost a mean CAD$1787 more per case (p < 0.01). Conclusion. RSA criteria suggest that both groups will have revision rates of approximately 3% at five years. The advantages of PSI were minimal or absent for surgical resources used and waste eliminated, and for meeting target alignment, yet had significantly greater costs. Therefore, we conclude that PSI may not offer any advantage over CSI for routine primary TKA cases. Cite this article: Bone Joint J 2019;101-B:565–572


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 53 - 53
1 Jan 2016
Talati R Alvi H Sweeney P Patel A Stulberg SD
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Introduction. Total knee arthroplasty is effective for the management of osteoarthritis of the knee. Conventional techniques utilizing manual instrumentation (MI) make use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. While MI techniques can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may be technically more challenging, resulting in poorer outcomes. Computer-assisted navigation (CAN) is an alternative that utilizes fixed trackers and anatomic registration points, foregoing the need for intramedullary guides. This technique has been shown to yield excellent results including superior alignment outcomes compared to MI with fewer outliers. However, studies report a high learning curve, increased expenses and increased operative times. As a result, few surgeons are trained and comfortable utilizing CAN. Patient-specific instrumentation is an alternative innovation for total knee arthroplasty. Custom guide blocks are fabricated based on a patient's unique anatomy, allowing for the benefits of CAN but without the increased operative times or the high learning curve. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware of the femur. Methods. After reviewing our database of 300 PSI total knee arthroplasty patients, 16 were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side [Figure 1], 1 had a sliding hip screw, and 1 patient had a cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs [Figure 2]. The American Knee Society Score was used to evaluate clinical outcomes postoperatively. Results. Sixteen total knee arthroplasties were performed using PSI, all in the setting of previous ipsilateral hardware placement. The average age at the time of surgery was 72, with patients ranging from 56 to 85 years of age [Table 1]. 11 of the included knees had a preoperative varus alignment and 5 had valgus alignment. The average value of a deformity identified via the preoperative planning software was 7.9°(1.5°–15.7°). The average value of a deformity identified via preoperative radiographs was 10.1°(2.2°–14.7°). Average postoperative mechanical axis was 3.1° (1°–5.3°) measured from plain radiographs. Average angle between the FMA and femoral component was 90.0° (85.3°–94.1°). The average angle between the TMA and tibial component was 90.6°(87.6°–92.9°). The average difference between the femoral mechanical and anatomic axes was 5.9°(3.4°–7.0°). The average discrepancy between medial and lateral joint space on an anterior-posterior standing radiograph was 0.4mm(0.0mm–1.1mm). At an average of 4.5 months follow-up, American Knee Society knee scores show an aggregate average score of 82.94. Conclusions. Patient specific instrumentation (PSI) is an innovative technology in TKA that replaces the use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. This study demonstrates that PSI is capable of producing favorable radiographic and clinical outcomes despite preexisting ipsilateral hardware, which may otherwise preclude the use of customary manual instrumentation. We believe PSI is an accurate and effective tool for use in patients with preexisting ipsilateral hardware


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 124 - 124
1 May 2016
Pauzenberger L Schwameis E Heuberer P Laky B Kriegleder B Anderl W
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Introduction. Patient-specific instrumentation (PSI) is a contemporary method to optimize accuracy of alignment in total knee arthroplasty (TKA). As the potential benefits come at the cost of increased economic and logistic expenses, there is great scientific and practical interest in the actual advantages and reliability of such systems. Therefore, the purpose of the present study was to compare clinical results, radiological limb alignment, and three-dimensional (3D)-component positioning between conventional instrumentation (CVI) and a computed tomographic (CT)-based PSI in primary TKA. Methods. Two-hundred-ninety consecutive patients (300 knees) with severe, debilitating osteoarthritis scheduled for TKA were included in this study using either CVI (n=150) or PSI (n=150). Patients were clinically assessed according to the Knee Society Score (KSS), range of motion (ROM), and visual analog scale for pain (VAS) before and two years after surgery. Hip-knee-ankle angle (HKA) and 3D-component positioning were assessed on postoperative radiographs and CT to evaluate accuracy of CVI and PSI. Results. Data of 222 knees (CVI: n=108, PSI: n=114) were available for analysis after a mean follow up of 28.6±5.2 months. Clinical (KSS knee and function, ROM, VAS) and radiological parameters (HKA) improved significantly from pre to postoperative in both groups. At the early follow up, clinical outcome was comparable between the two groups, whereas KSS function and VAS for pain were significantly better in the PSI group. Mean HKA deviation from the targeted neutral mechanical axis (CVI: 2.2°±1.7°; PSI: 1.5°±1.4°; p<0.001), rates of outliers (CVI: 22.2%; PSI: 9.6%; p=0.016), and 3D-component positioning outliers were significantly lower in the PSI group. Additionally, the accuracy of femoral and tibial component positioning was significantly higher in all planes. At early follow up, all clinical scores were significantly better in the subgroup of HKA non-outliers (HKA: 180°±3°) compared to HKA outliers. Conclusions. CT-based PSI compared to CVI improves accuracy of mechanical alignment restoration and 3D-component positioning in primary TKA. While clinical outcome was comparable between the two instrumentation groups at early follow up, significantly inferior outcome was detected in the subgroup of HKA-outliers


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_3 | Pages 140 - 140
1 Feb 2017
Goldberg T Torres A Bush J
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Introduction. Total Knee Arthroplasty (TKA) is highly successful in treatment of end-stage degenerative arthritis of the knee. CT-based Patient-Specific Instrumentation (PSI) utilizes a CT scan of the lower extremity to create a three-dimensional model of the patient's anatomy, plan the surgery, and provide unique patient-specific resection blocks for the surgery. There are few published studies utilizing CT-PSI. The present study prospectively evaluates clinical, operative, and radiographic outcomes from 100 CT-based TKAs using this technology (MyKnee®, Medacta International S.A., Castel San Pietro, Switzerland). Materials and Methods. 100 consecutive eligible knees (94 patients) of the senior author underwent TKA using CT-based PSI technology. The primary outcome of the study was to compare the planned pre-operative femoral and proximal tibial resections to the actual intra-operative measured resections. Clinical outcomes included pre- and post-operative Knee Society Scores, Range-of-Motion (ROM, measured by goniometer), and complication data. Pre- and 6-week post-operative long-leg standing radiographs were obtained to assess HKA alignment. The femoral component angle (FCA) in the coronal plane, the tibial component angle (TCA), and posterior slope of the tibia were also assessed. Additionally, 10 patients were selected at random to undergo a post-operative CT scan for comparison to radiographic measurements. Results. 94 patients were enrolled representing 51 left and 49 right TKAs. Average follow up was 3.9 years (range 3.5 – 4.4 years). Average Knee Society Score (KSS) improved from 44.3 to 81.8 while KSS Function Score improved from 59.1 to 81.8 at 1 year. ROM arc of the patients was 110.5 (range 0–130) pre-operatively and was 111.3 (range 0–130) post-operatively. Two patients had a post-operative infection requiring surgical intervention. There were no thromboembolic complications and no revisions in study patients. No patient required a manipulation under anesthesia for post-operative stiffness. No intraoperative complications occurred nor were there any cases of abandoning the PSI blocks for standard technique. The actual bony resections achieved during surgery were strongly correlated to the planned resections of all 6 bone fragments measured. Each achieved statistical significance (p<0.001). Average post-operative alignment was 179.36° (range 175°–186°). Alignment was 180 ± 3° in 94% of patients post-operatively. Ten patients underwent a post-operative CT scan for HKA verification. The average post-operative HKA was 179.9° (range, 176.9°–180.9°) with a standard deviation of 1.31°. When comparing our pre-operative alignment by x-ray vs. CT, we found only 0.09° (p<0.001) average difference between them. Post-operatively, we continued to show very similar results showing x-ray HKA measurement of 180.1° vs. CT measurement of 179.9° (p<0.001). Discussion. The pre-operative CT reconstruction can accurately predict the intra-operative resection depths as demonstrated here. All 6 bony resections measured to within 1mm of the predicted value in the aggregate of our series. The restoration of mechanical axis to 179.9° as measured by CT scans demonstrates the efficacy of the blocks. Conclusion. The present study demonstrates efficacy in the use of CT-based PSI - showing that the planning can accurately predict bony resections, be used safely, and achieve precise radiographic outcomes. Consequently, we routinely support the use of CT-based PSI in TKA


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 2 - 2
1 Dec 2017
Seeber GH Kolbow K Maus U Kluge A Lazovic D
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Patient-specific instrumentation (PSI) has been greatly marketed in knee endoprosthetics for the past few years. By utilising PSI, the prosthesis´ accuracy of fit should be improved. Besides, both surgical time and hospital costs should be reduced. Whether these proposed advantages are achieved in medial UKA remains unclear yet. The aim of this study was to evaluate the preoperative planning accuracy, time saving, and cost effectiveness utilising PSI in UKA. Data from 22 patients (24 knees) with isolated medial unicompartmental knee osteoarthritis were analysed retrospectively. The sample comprised sixteen men and six women (mean age 61 ± 8 years) who were electively provided with a UKA utilising PSI between June 2012 and October 2014. For evaluation of preoperative planning accuracy (1) planned vs. implanted femoral component size, (2) planned vs. implanted tibial component size, and (3) planned vs. implanted polyethylene insert size were analysed. Since UKA is a less common, technically demanding surgery, depending in large part on the surgeon´s experience, preoperative planning reliability was also evaluated with regard to surgeon experience. Moreover, actual surgical time and cost effectiveness utilising PSI was evaluated. Preoperative planning had to be modified intraoperatively to a wide extend for gaining an optimal outcome. The femoral component had to be adjusted in 41.7% of all cases, the tibial component in 58.3%, and the insert in 87.5%. Less experienced surgeons had to change preoperative planning more often than experienced surgeons. Utilising PSI increased surgical time regardless of experience. Linear regression revealed PSI-planning and surgeon inexperience as main predictors for increased surgical time. Additionally, PSI increased surgical costs due to e.g. enlarged surgical time, license fees and extraordinary expenditure for MRI scans. The preoperative planning accuracy depends on many different factors. The advertised advantages of PSI could not be fully supported in case of UKA on the basis of the here presented data – especially not for the inexperienced surgeon


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_4 | Pages 28 - 28
1 Jan 2016
Stirling P Mannambeth RV Soler JA Batta V Malhotra RK Kalairajah Y
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Introduction. Increased accuracy of pre-operative imaging in patient-specific instrumentation (PSI) can result in longer-term savings, and reduced accumulated dose of radiation by eliminating the need for post-operative imaging or revision surgery. The benefits and drawbacks of CT vs MRI for use in PSI is a source of ongoing debate. This study reviews all currently available evidence regarding accuracy of CT vs MRI for pre-operative imaging in PSI. Methods. The MEDLINE and EMBASE databases were searched between 1990 and 2013 to identify relevant studies. As most studies available focus on validation of a single technique rather than a direct comparison, the data from several clinical studies was assimilated to allow comparison of accuracy. Overall accuracy of each modality was calculated as proportion of outliers >3 % in the coronal plane. Results. Seven studies matched our inclusion criteria. Outlier incidence was 12.5% (9.27–17.4%) with CT and 16.96% (1.2–44%) with MRI (p>0.05). Conclusions. Current evidence shows comparable accuracy with both imaging modalities for PSI. Outlier incidence is slightly lower in the CT group with lower variation but this was not significant. At present there is not enough published data to convincingly conclude in favour of CT or MRI for accuracy of component alignment. It is our conclusion that CT is more favourable at present due to reduced scanning times, increased availability, and cheaper cost


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 5 - 5
1 Aug 2013
Goldberg T Curry W Bush J
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The present IRB approved study evaluates the early results of 100 TKAs using CT-based Patient-Specific Instrumentation (PSI) (MyKnee®, Medacta International, SA, Castel San Pietro, Switzerland). For this technique, a CT scan of the lower extremity is obtained, and from these images, the knee is reconstructed 3-dimensionally. Surgical and implant-size planning are performed according to surgeon preference, with the goal to create a neutral mechanical axis. Once planned and approved, the blocks are made. Outcomes measured for the present study include surgical factors such as Tourniquet Time (TT) as a measure of surgical efficiency, the actual intraoperative bony resection thicknesses to be compared to the planned resections from the CT scan, and complication data. Furthermore, pre- and post-operative long standing alignment and Knee Society Scores (KSS) were obtained. During surgery, the PSI cutting block is registered on the femur first and secured with smooth pins. No osteophytes are removed as the blocks use the positive topography of the osteophytes for registration. The distal femoral resection is performed directly through the block. An appropriate sized 4-in-1 block is placed and the remaining resections are performed. The tibial resection block is registered and resection performed. Final bone preparation, patella resurfacing, and trialing is performed as is standard to all surgical techniques. There were 50 Left and 50 Right TKA's performed in 61 females and 39 males. All patients had diagnosis of osteoarthritis. The average BMI was 31.1 and average age was 64.5 (range 41–90). 79 patients had pre-operative varus deformities with Hip Knee Angle (HKA) average of 174.7° (range 167°–179.5°). 19 patients had pre-operative valgus deformities averaging 184.4° (range 180.5°–190°). Three patients were neutral. Average TT was 31.2 minutes (range 21–51 minutes). With regard to the bony resections, the actual vs. planned resections for the distal medial femoral resection was 8.7 mm vs. 8.9 mm respectively. Further actual vs. planned femoral resections include distal lateral 7.2 vs. 6.7 mm; posterior medial 8.3 vs. 8.9 mm; and posterior lateral 6.2 vs. 6.8 mm. The actual vs. planned tibial resections recorded include medial 6.4 vs. 6.3 mm and lateral 8.3 vs. 8.2. The planned vs. actual bony cuts are strongly correlated, and highly predictive for all 6 measured cuts (p=<.001). No intraoperative complications occurred. Average KSS improved from 45.9 to 81.4, and KSS Function Score improved from 57.7 to 73.5 at 6 weeks postoperative visit. There were no thromboembolic complications. Two patients had a post-operative infection requiring surgical intervention. Post-operative alignment was 179.36° (range 175°–186°) for all patients. Alignment was neutral, within 3° in 95.9% of patients. There were only 4 outliers with maximal post-operative angulation of 6°. In conclusion, these early results demonstrate efficacy of CT-based PSI for TKA. The surgery can be performed efficiently, accurately, and safely. Furthermore, excellent short term clinical and radiographic results can be achieved


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 325 - 325
1 Dec 2013
Goldberg T Curry WT Bush JW
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The present IRB approved study evaluates the early results of 100 TKAs using CT-based Patient-Specific Instrumentation (PSI) (MyKnee®, Medacta International, SA, Castel San Pietro, Switzerland). For this technique, a CT scan of the lower extremity is obtained, and from these images, the knee is reconstructed 3-dimensionally. Surgical and implant-size planning are performed according to surgeon preference, with the goal to create a neutral mechanical axis. Once planned and approved, the blocks are made [Fig. 1]. Outcomes measured for the present study include surgical factors such as Tourniquet Time (TT) as a measure of surgical efficiency, the actual intraoperative bony resection thicknesses to be compared to the planned resections from the CT scan, and complication data. Furthermore, pre- and post-operative long standing alignment and Knee Society Scores (KSS) were obtained. During surgery, the PSI cutting block is registered on the femur first and secured with smooth pins. No osteophytes are removed as the blocks use the positive topography of the osteophytes for registration. The distal femoral resection is performed directly through the block. An appropriate sized 4-in-1 block is placed and the remaining resections are performed. The tibial resection block is registered and resection performed. Final bone preparation, patella resurfacing, and trialing is performed as is standard to all surgical techniques. There were 50 Left and 50 Right TKA's performed in 61 females and 39 males. All patients had diagnosis of osteoarthritis. The average BMI was 31.1 and average age was 64.5 (range 41–90). 79 patients had pre-operative varus deformities with Hip Knee Angle (HKA) average of 174.7° (range 167°–179.5°). 19 patients had pre-operative valgus deformities averaging 184.4° (range 180.5°–190°). Three patients were neutral. Average TT was 31.2 minutes (range 21–51 minutes). With regard to the bony resections, the actual vs. planned resections for the distal medial femoral resection was 8.7 mm vs. 8.9 mm respectively. Further actual vs. planned femoral resections include distal lateral 7.2 vs. 6.7 mm; posterior medial 8.3 vs. 8.9 mm; and posterior lateral 6.2 vs. 6.8 mm. The actual vs. planned tibial resections recorded include medial 6.4 vs. 6.3 mm and lateral 8.3 vs. 8.2. The planned vs. actual bony cuts are strongly correlated, and highly predictive for all 6 measured cuts (p=<.001) [Fig. 3]. No intraoperative complications occurred. Average KSS improved from 45.9 to 81.4, and KSS Function Score improved from 57.7 to 73.5 at 6 weeks postoperative visit. There were no thromboembolic complications. Two patients had a post-operative infection requiring surgical intervention. Post-operative alignment was 179.36° (range 175°–186°) for all patients. Alignment was neutral, within 3° in 95.9% of patients. There were only 4 outliers with maximal post-operative angulation of 6° [Fig. 2]. In conclusion, these early results demonstrate efficacy of CT-based PSI for TKA. The surgery can be performed efficiently, accurately, and safely. Furthermore, excellent short term clinical and radiographic results can be achieved


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 121 - 121
1 May 2016
Kosse N Heesterbeek P Schimmel J Van Hellemondt G Wymenga A Defoort K
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Background. To improve implant positioning in total knee arthroplasty (TKA) patient-specific instrumentation (PSI) has been introduced as alternative for conventional instrumentation (CI). Though the PSI technique offers interesting opportunities in TKA, there is no consensus about the effectiveness of PSI in comparison with CI and results concerning soft-tissue balancing remain unclear. Therefore, the primary aim of the present study was to investigate the varus-valgus laxity in extension and flexion in patients receiving a TKA using PSI compared with CI. Additionally, radiological, clinical and functional outcomes were assessed. Methods. In this prospective randomization controlled trial, 42 patients with osteoarthritis received a Genesis II PS (Smith & Nephew, Memphis, Tennessee), with either PSI (Visionaire, Smith & Nephew) or CI (Smith & Nephew). Patients visited the hospital preoperative and postoperative after 6 weeks, 3 and 12 months. One-year postoperative varus-valgus laxity was measured in extension and flexion on stress radiographs. Additional assessments included: the hip-knee-ankle angle on long-leg radiographs, femoral and tibia component rotation on CT-scans, radiolucency, the Knee Society Score (KSS), VAS pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score (KOOS), Patella score (Kujala), the University of California Los Angeles activity score (UCLA), the anterior-posterior laxity in 20° and 90° knee flexion, adverse events and complications. The outcome measures were compared using independent t-tests, non-parametric alternatives and repeated measurements, with a significance level of p<0.05. Results. In four cases intra-operative modifications were needed, since the PSI did not fit correctly on the tibia and/or femur. No significant differences were found between the two groups for varus-valgus laxity in both extension and flexion (figure 1), as well as for the other radiological outcomes. Both groups improved significantly on clinical and functional outcomes over time. No significant differences were found between the groups one year postoperatively. Finally, the PSI group received a thinner insert than the CI group (p=0.04). Conclusion. In conclusion, PSI in TKA does not result in better varus-valgus laxity, and clinical and functional outcomes compared with CI, one year postoperative. Since the PSI group received a thinner insert, the pre-operative surgery plan developed for he PSI probably provides more conservative bone cuts compared with CI. The thinner insert might be beneficial in the long-term; however, further research is needed to gain more insight in the long-term results of PSI


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 326 - 326
1 Dec 2013
Curry WT Goldberg T Bush JW
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Hardware in or about the knee joint presents a number of challenges to the surgeon in performance of Total Knee Arthroplasty (TKA). Conventional instrumentation usually requires a modification of technique or removal of the metallic implants. Computer-Assisted TKA (CAOS) is another option, but adds complexity and time to the procedure. MRI-based Patient-Specific Instrumentation (PSI) cannot be used as metal causes unwanted artifact and renders the images for planning, useless. However, CT scans are not affected by metal and thus CT-based PSI can be used in TKA patients with pre-existing hardware. The present IRB approved study evaluates 12 consecutive knees (10 patients) with pre-existing hardware using CT-based PSI (MyKnee®, Medacta International, SA, Castel San Pietro, Switzerland). In this technique, CT scan of the lower extremity is obtained, and from these images, the knee is reconstructed 3-dimensionally. Surgical and implant-size planning are performed according to surgeon preference, with the goal to create a neutral mechanical axis. Once planned and approved, the blocks are made [Fig 1]. During surgery, the PSI cutting block is registered on the femur first and secured with smooth pins. The distal femoral resection is performed directly through the block. An appropriate sized 4-in-1 block is placed and the remaining femoral resections are performed. The tibial resection block is registered and resection performed. Final bone preparation, patella resurfacing, and trialing is performed as is standard to all surgical techniques. Of the 12 TKAs, there were 5 left and 7 right knees performed in 6 females and 6 males. The average BMI was 33.19 and average age was 53 (range 44–63). All diagnoses were either osteoarthritis or post-traumatic osteoarthritis. Follow-up averaged 59 weeks (range 18.6–113.7). Nine patients had pre-operative varus deformities with HKA deformities average of 171.9° (range 154°–178.5°). One patient had pre-operative valgus deformity of 184.5°. Two patients were neutral (180°). Post-operative alignment for all patients (n = 11) was 179° (range 177°–180°). All patients were within 3° neutral, post operatively. Four patients measured 180°, 4 measured at 179°, 2 measured at 178°, and only one at 177°. Hardware consisted of 5 patients with femur or tibia staples, 3 with plate(s) and screws [Fig. 2], 3 patients with ACL interference screws, and one titanium rod. No hardware was removed unless necessary for implantation. Only 3 patients required some hardware removal. The pre-operative Range of Motion (ROM) averaged 2.9° to 98.3° (Extension range 0–15° and flexion range 30–115°). Post-operative ROM was 2.9° to 101.3°. (Extension range 0–5° and flexion range 65–125°). Knee Society Score (KSS) improved from 42.3 to 82.3, and KSS Function Score improved from 52.1 to 77.5. No intraoperative complications were recorded. Average tourniquet time was 42.1 minutes (range 28–102). Regardless of the deformity, the patient's post-operative mechanical axes HKA averaged 179° (range 177–180). Clinical scores were typical for TKA patients with improvement in both KSS and ROM. In conclusion, early results using PSI in patients with pre-existing hardware in or about the joint, is safe, efficient, and accurate in performance of TKA


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 4 - 4
1 Aug 2013
Goldberg T Curry W Bush J
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Hardware in or about the knee joint presents a number of challenges to the surgeon in performance of Total Knee Arthroplasty (TKA). Conventional instrumentation usually requires a modification of technique or removal of the metallic implants. Computer-Assisted TKA (CAOS) is another option, but adds complexity and time to the procedure. MRI-based Patient-Specific Instrumentation (PSI) cannot be used as metal causes unwanted artifact and renders the images for planning, useless. However, CT scans are not affected by metal and thus CT-based PSI can be used in TKA patients with pre-existing hardware. The present IRB approved study evaluates 12 consecutive knees (10 patients) with pre-existing hardware using CT-based PSI (MyKnee®, Medacta International, SA, Castel San Pietro, Switzerland). In this technique, CT scan of the lower extremity is obtained, and from these images, the knee is reconstructed 3-dimensionally. Surgical and implant-size planning are performed according to surgeon preference, with the goal to create a neutral mechanical axis. Once planned and approved, the blocks are made. During surgery, the PSI cutting block is registered on the femur first and secured with smooth pins. The distal femoral resection is performed directly through the block. An appropriate sized 4-in-1 block is placed and the remaining femoral resections are performed. The tibial resection block is registered and resection performed. Final bone preparation, patella resurfacing, and trialing is performed as is standard to all surgical techniques. Of the 12 TKAs, there were 5 left and 7 right knees performed in 6 females and 6 males. The average BMI was 33.19 and average age was 53 (range 44–63). All diagnoses were either osteoarthritis or post-traumatic osteoarthritis. Follow-up averaged 59 weeks (range 18.6–113.7). Nine patients had pre-operative varus deformities with HKA deformities average of 171.9° (range 154°–178.5°). One patient had pre-operative valgus deformity of 184.5°. Two patients were neutral (180°). Post-operative alignment for all patients (n=11) was 179° (range 177°–180°). All patients were within 3° neutral, post operatively. Four patients measured 180°, 4 measured at 179°, 2 measured at 178°, and only one at 177°. Hardware consisted of 5 patients with femur or tibia staples, 3 with plate(s) and screws, 3 patients with ACL interference screws, and one titanium rod. No hardware was removed unless necessary for implantation. Only 3 patients required some hardware removal. The pre-operative Range of Motion (ROM) averaged 2.9° to 98.3° (Extension range 0–15° and flexion range 30–115°). Post-operative ROM was 2.9° to 101.3°. (Extension range 0–5° and flexion range 65–125°). Knee Society Score (KSS) improved from 42.3 to 82.3, and KSS Function Score improved from 52.1 to 77.5. No intraoperative complications were recorded. Average tourniquet time was 42.1 minutes (range 28–102). Regardless of the deformity, the patient's post-operative mechanical axes HKA averaged 179° (range 177–180). Clinical scores were typical for TKA patients with improvement in both KSS and ROM. In conclusion, early results using PSI in patients with pre-existing hardware in or about the joint, is safe, efficient, and accurate in performance of TKA


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 152 - 152
1 May 2016
Zhu M Chen J Chong H Yew A Foo L Chia S Lo N Yeo S
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Objective. Patient-specific instrumentation (PSI) is a novel technique in total knee arthroplasty (TKA) which potentially permits more accurate alignment of the components; however, there is no consensus in literature regarding the accuracy and reliability of PSI as many studies have shown controversial and inconsistent results of various PSI systems. A 24-month follow-up study was carried out to compare perioperative clinical outcomes, radiological limb alignment and component positioning, as well as functional outcomes following TKA between PSI and conventional instrumentation (CI). Methods. During September 2011 and August 2012, 90 consecutive patients were scheduled to undergo unilateral TKA with either PSI or CI. TruMatch® Personalised Solutions was used in this study, and a senior surgeon performed all operations. Patients were clinically assessed before, 6-month and 24-month after surgery. Results. There were 42 patients who underwent TKA with PSI and 48 patients with CI, with no preoperative demographic and clinical difference. There was significant improvement in maximal extension for both groups at both of the two follow-ups, compared to baseline. While the CI group maintained similar maximal flexion angle, PSI group had significant decrease in maximal flexion angle, at both follow-ups. Overall, there was no significant improvement in the range of motion for both groups over the 24-month period after surgery. At 6 and 24 months postoperatively, there were similarly significant improvements in the mean scores of Oxford Knee Score, Knee Society Score, and Physical Component Sscore of the SF-36 Health Survey for both groups. At 24 months postoperatively, no significant differences were detected between PSI and CI groups in all clinical and functional outcomes. Radiographic results showed that the lower limb mechanical alignment and coronal component positioning were satisfactory and similar between the two groups. There were no differences in operating time, haemoglobin loss, transfusion rate and length of hospitalisation between PSI and CI, perioperatively. Conclusion. In conclusion, CT-based PSI showed comparable clinical and functional outcomes at 24 months after TKA compared with CI. There were no significant differences between the two types of instruments in achieving alignment restoration, component positioning, and perioperative clinical outcomes in terms of operating time and blood loss


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 109 - 109
1 Apr 2019
Wakelin E Twiggs J Moore E Miles B Shimmin A
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Introduction & aims

Patient specific instrumentation (PSI) is a useful tool to execute pre-operatively planned surgical cuts and reduce the number of trays in surgery. Debate currently exists around improved accuracy, efficacy and patient outcomes when using PSI cutting guides compared to conventional instruments. Unicompartmental Knee Arthroplasty (UKA) revision to Total Knee Arthroplasty (TKA) represents a complex scenario in which traditional bone landmarks, and patient specific axes that are routinely utilised for component placement may no longer be easily identifiable with either conventional instruments or navigation. PSI guides are uniquely placed to solve this issue by allowing detailed analysis of the patient morphology outside the operating theatre. Here we present a tibia and femur PSI guide for TKA on patients with UKA.

Method

Patients undergoing pre-operative planning received a full leg pass CT scan. Images are then segmented and landmarked to generate a patient specific model of the knee. The surgical cuts are planned according to surgeon preference. PSI guide models are planned to give the desired cut, then 3D printed and provided along with a bone model in surgery. PSI-bone and PSI-UKA contact areas are modified to fit the patient anatomy and allow safe placement and removal.

The PSI-UKA contact area on the tibia is defined across the UKA tibial tray after the insert has been removed. Further contact is planned on the tibial eminence if it can be accurately segmented in the CT and the anterior superior tibia on the contralateral compartment, see example guide in Figure 1. Contact area on the femur is defined on the superior trochlear groove, native condyle, femur centre and femoral UKA component if it can be accurately segmented in the CT.

Surgery was performed with a target of mechanical alignment using OMNI APEX PS implants (Raynham, MA). The guide was planned such that the OMNI cut block could be placed on the securing pins to translate the cut. Component alignment and resections values were calculated by registering the pre-operative bones and component geometries to post-operative CT images.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 54 - 54
1 May 2016
Goyal N Stulberg S
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Introduction

Given the association of osteoarthritis with obesity, the typical patient requiring total knee arthroplasty (TKA) is often obese. Obesity has been shown to negatively influence outcomes following TKA, as it is associated with increased perioperative complications and poorer clinical and functional outcomes. Achieving proper limb alignment can be more difficult in the obese patient, potentially requiring a longer operation compared to non-obese patients. Patient specific instrumentation (PSI), a technique that utilizes MR- or CT-based customized guides for intraoperative cutting block placement, may offer a more efficient alternative to manual instruments for the obese patient. We hypothesize that the additional information provided by a preoperative MRI or CT may allow surgeons to achieve better alignment in less time compared to manual instrumentation. The purpose of this study was to assess whether PSI offers an improved operation length or limb alignment compared to manual instruments for nonmorbidly and morbidly obese patients.

Methods

In this retrospective cohort study, we evaluated 77 PSI TKA and 25 manual TKA performed in obese patients (BMI≥30) between February 2013 and May 2015. During this period, all patients underwent PSI TKA unless unable to undergo MR scanning. All cases were performed by a single experienced surgeon and utilized a single implant system (Zimmer Persona™). PSI cases were performed using the MR-based Zimmer Patient Specific Instrumentation system. Tourniquet times were recorded to determine length of operation. Long-standing radiographs were obtained preoperatively and 4-weeks postoperatively to evaluate limb alignment. Cases were subdivided by nonmorbid obesity (30≤BMI<40) and morbid obesity (BMI≥40) to assess the effect of increasing obesity on outcomes.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1342 - 1346
1 Oct 2016
Spencer-Gardner L Pierrepont J Topham M Baré J McMahon S Shimmin AJ

Aims

Accurate placement of the acetabular component during total hip arthroplasty (THA) is an important factor in the success of the procedure. However, the reported accuracy varies greatly and is dependent upon whether free hand or navigated techniques are used. The aim of this study was to assess the accuracy of an instrument system that incorporates 3D printed, patient-specific guides designed to optimise the placement of the acetabular component.

Patients and Methods

A total of 100 consecutive patients were prospectively enrolled and the accuracy of placement of the acetabular component was measured using post-operative CT scans.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 21 - 21
1 Aug 2020
Somerville L Zomar B Vasarhelyi E Lanting B Howard J Marsh J
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Total knee arthroplasty is a successful procedure that reduces knee pain and improves function in most patients with knee osteoarthritis. Patient dissatisfaction however remains high, and along with implant longevity, may be affected by component positioning. Surgery in obese patients is more technically challenging with difficulty identifying appropriate landmarks for alignment and more difficult exposure of the joint. Patient specific instrumentation (PSI) has been introduced with the goal to increase accuracy of component positioning by custom fitting cutting guides to the patient using advanced imaging. A strong criticism of this new technology however, is the cost associated. The purpose of this study was to determine, using a prospective, randomized-controlled trial, the cost-effectiveness of PSI compared to standard instrumentation for total knee arthroplasty in an obese patient population.

Patients with a body mass index greater than 30 with osteoarthritis and undergoing a primary total knee arthroplasty were included in this study. We randomized patients to have their procedure with either standard instrumentation (SOC) or PSI. At 12-weeks post-surgery patients completed a self-reported cost questionnaire and the Western Ontario and McMaster Osteoarthritis Index (WOMAC). We performed a cost-effectiveness analyses from a public health payer and societal perspective. As we do not know the true cost of the PSI instrumentation, we estimated a value of $100 for our base case analysis and used one-way sensitivity analyses to determine the effect of different values (ranging from $0 to $500) would have on our conclusions.

A total of 173 patients were enrolled in the study with 86 patients randomized to the PSI group and 87 to the SOC group. We found the PSI group to be both less effective and more costly than SOC when using a public payer perspective, regardless of the cost of the PSI. From a societal perspective, PSI was both less costly, but also less effective, regardless of the cost of the PSI. The mean difference in effect between the two groups was −1.61 (95% CI −3.48, 026, p=0.091). The incremental cost-effectiveness ratio was $485.71 per point increase in the WOMAC, or $7285.58 per clinically meaningful difference (15 points) in the WOMAC.

Overall, our results suggest that PSI is not cost-effective compared to standard of care from a public payer perspective. From a societal perspective, there is some question as to whether the decreased effect found with the PSI group is worth the reduced cost. The main driver of the cost difference appears to be time off of volunteer work, which will need to be investigated further. In future, we will continue to follow these patients out to one year to collect cost and effectiveness data to investigate whether these results remain past 12 weeks post-surgery.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 67 - 67
1 Nov 2021
Zaffagnini S
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The medial opening-wedge high tibial osteotomy (OW-HTO) is an accepted option to treat the isolated medial compartment osteoarthritis (OA) in varus knee. Despite satisfactory outcomes were described in literature, consistent complication rate has been reported and the provided accuracy of coronal alignment correction using conventional HTO techniques falls short.

Patient specific instrumentations has been introduced with the aim to reduce complications and to improve the intra-operative accuracy according to the pre-operative plan, which is responsible for the clinical result of the surgery.

In this talk, an overview of the clinical results of HTO patient specific instrumentation available in literature will be performed.

Moreover, preliminary intra-operative and clinical results of a new customised 3-D printed cutting guide and fixation plate for OW-HTO will be presented.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_18 | Pages 4 - 4
1 Dec 2014
Thati S Aranganathan S Ganapathi M
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Patient specific instrumentation (PSI) is the latest advancement in total knee arthroplasty (TKA), which claims to improve alignment, simplify the surgical process, forecasts the component size and reduces the operating time. We discuss our experience of preoperative planning using default settings and making changes where necessary.

We analysed prospectively collected data in 100 consecutive PSI knee replacements (Zimmer®) performed in our institute during the period February to August 2012. All patients underwent MRI scans of the ipsilateral hip, knee and ankle joints. From the images, Materialise® (Leuven, Belgium) provided 3D model of the knee on which preoperative planning was done using PSI software. All default plans were checked and appropriate changes were made before the senior author approved final plan for preparation of patient specific moulds.

We made 636 changes (6.36 changes per knee) preoperatively from the default settings. In only 4% of the patients, the primary cuts needed revision. Thus in 96% of the cases, the primary cuts allowed optimal alignment and gap balancing with appropriate soft tissue release. Our preoperative planning predicted 99% of femoral and 98% of tibial component sizes definitively implanted.

Our results show the importance of the surgeon's input in approving preoperative planning with this technique.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 46 - 46
1 Mar 2017
Teeter M Howard J Vasarhelyi E Yuan X McCalden R Naudie D
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Background

Patient specific instrumentation (PSI) for total knee replacement (TKR) has demonstrated mixed success in simplifying the operation, reducing its costs, and improving limb alignment. Evaluation of PSI with tools such as radiostereometric analysis (RSA) has been limited, especially for cut-through style guides providing mechanical alignment. The primary goal of the present study was to compare implant migration following TKR using conventional and PSI surgical techniques, with secondary goals to examine whether the use of PSI reduces operative time, instrumentation, and surgical waste.

Methods

The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and conventional groups, powered for the RSA analysis. Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical alignment. All patients received the same posterior-stabilized implant, with marker beads inserted in the bone around the implants to enable RSA imaging. Intraoperative variables such as time, number of instrumentation trays used, and mass of surgical waste were recorded. Patients underwent supine RSA exams at multiple time points (2&6 weeks, 3&6 months and yearly) with 6 months data currently available. Migration of the tibial and femoral components was calculated using model-based RSA software. WOMAC, SF-12, EQ5D, and UCLA outcome measures were recorded pre-operatively and post-operatively.


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1052 - 1061
1 Aug 2014
Thienpont E Schwab PE Fennema P

We conducted a meta-analysis, including randomised controlled trials (RCTs) and cohort studies, to examine the effect of patient-specific instruments (PSI) on radiological outcomes after total knee replacement (TKR) including: mechanical axis alignment and malalignment of the femoral and tibial components in the coronal, sagittal and axial planes, at a threshold of > 3º from neutral. Relative risks (RR) for malalignment were determined for all studies and for RCTs and cohort studies separately.

Of 325 studies initially identified, 16 met the eligibility criteria, including eight RCTs and eight cohort studies. There was no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKR across all studies (RR = 0.84, p = 0.304), in the RCTs (RR = 1.14, p = 0.445) or in the cohort studies (RR = 0.70, p = 0.289). The results for the alignment of the tibial component were significantly worse using PSI TKR than conventional TKR in the coronal and sagittal planes (RR = 1.75, p = 0.028; and RR = 1.34, p = 0.019, respectively, on pooled analysis). PSI TKR showed a significant advantage over conventional TKR for alignment of the femoral component in the coronal plane (RR = 0.65, p = 0.028 on pooled analysis), but not in the sagittal plane (RR = 1.12, p = 0.437). Axial alignment of the tibial (p = 0.460) and femoral components (p = 0.127) was not significantly different.

We conclude that PSI does not improve the accuracy of alignment of the components in TKR compared with conventional instrumentation.

Cite this article: Bone Joint J 2014; 96-B:1052–61.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_5 | Pages 54 - 54
1 Feb 2016
Darwood A Emery R Reilly P Richards R Baena FRY Tambe A
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Introduction

Optimal orthopaedic implant placement is a major contributing factor to the long term success of all common joint arthroplasty procedures. Devices such as 3D printed bespoke guides and orthopaedic robots are extensively described in the literature and have been shown to enhance prosthesis placement accuracy. These technologies have significant drawbacks such as logistical and temporal inefficiency, high cost, cumbersome nature and difficult theatre integration. A radically new disruptive technology for the rapid intraoperative production of patient specific instrumentation that obviates all disadvantages of current technologies is presented.

Methods

An ex-vivo validation and accuracy study was carried out using the example of placing the glenoid component in a shoulder arthroplasty procedure.

The technology comprises a re-usable table side machine, bespoke software and a disposable element comprising a region of standard geometry and a body of mouldable material.

Anatomical data from 10 human scapulae CT scans was collected and in each case the optimal glenoid guidewire position was digitally planned and recorded.

The glenoids were isolated and concurrently 3D printed. In our control group, guide wires were manually inserted into 1 of each pair of unique glenoid models according to a surgeon's interpretation of the optimal position from the anatomy. The same surgeon used the guidance system and associated method to insert a guide wire into the second glenoid model of the pair.

Achieved accuracy compared to the pre-operative bespoke plan was measured in all glenoids in both the conventional group and the guided group.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 88 - 88
1 Dec 2016
Nam D
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A recent proposed modification in surgical technique in total knee arthroplasty (TKA) has been the introduction of patient specific instrumentation or custom cutting guides (CCGs). With CCGs, preoperative three-dimensional imaging is used to manufacture cutting blocks specific to a patient's native anatomy, with proposed benefits including their ease of use; a decrease in operative times and instrument trays and improved cost-efficiency; the ability to preoperative plan component size, alignment, and position; and an improvement in postoperative alignment versus the use of standard instrumentation. However, to date the majority of reports have not confirmed these proposed benefits.

Prior studies focusing on cost-efficiency have shown limited benefits in terms of operating and room turnover times, which fail to offset the additional cost of preoperative imaging and fabrication of the CCGs. Furthermore, a number of reports have noted the frequent need for surgeon-directed changes and alterations in alignment intraoperatively, along with errors in the predetermined implant size. The use of CCGs has also failed to improve overall mechanical and component alignment versus standard instrumentation in the majority of investigations. Perhaps most importantly, no investigation has demonstrated CCGs to improve clinical outcomes postoperatively. Therefore, in the absence of proven clinical or radiographic improvements, the continued implementation of CCGs must be questioned.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_22 | Pages 89 - 89
1 Dec 2016
Lombardi A
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Patient specific instruments have been developed in response to the conundrum of limited accuracy of intramedullary and extramedullary alignment guides and chaos caused by computer assisted orthopaedic surgery. This technology facilitates preoperative planning by providing the surgeon with a three dimensional (3-D) anatomical reconstruction of the knee, thereby improving the surgeon's understanding of the preoperative pathology. Intramedullary canal penetration of the femur and tibia is unnecessary, and consequently, any potential for fat emboli is eliminated. Component position and alignment are improved with a decrease in the number of outliers. Patient specific instruments utilise detailed magnetic resonance imaging (MRI) or computed tomography (CT) scans of the patient's knee with additional images from the hip and ankle for determination of critical landmarks. From these studies a 3-D model of the patient's knee is created and with integration of rapid prototyping technology, guides are created to apply to the patient's native anatomy to direct the placement of the cutting jigs and ultimately the placement of the components.

The steps in considering utilization of patient specific guides are as follows: 1) the surgeon determines that the patient is a candidate for TKA, 2) an MRI or CT scan is obtained at an approved facility in accordance with a specific protocol, 3) the MRI or CT is forwarded to the manufacturer, 4) the manufacturer creates the 3-D reconstructions, anatomical landmarks are identified, implant size is determined, and ultimately femoral and tibial component implant placement is determined via an algorithm, 4) the surgical plan is executed, 5) the physician reviews and modifies or approves the plan, 6) the guides are then produced via rapid prototyping technology and delivered to the hospital for the surgical procedure.

Guides generated from MRIs are designed to uniquely register on cartilage surface whereas guides produced from CT scans must register on bony anatomy. There are currently two types of guides produced: those which register on the femur and tibia and allow for the placement of pins to accommodate the standard resection blocks; and those produced by some manufacturers which accommodate the saw blade and therefore are a combination of resection and pin guides.

The utilization of patient-specific positioning guides in TKA has several benefits. They facilitate preoperative planning, obviate the need for violation of the intramedullary canals, reduce operating times and improve OR efficiency, decrease instrumentation requirements and thereby reduce potential for perioperative contamination. They are easier to use than computer navigation with no capital equipment purchase and no significant learning curve. Most importantly, patient-specific guides facilitate accurate component position and alignment, which ultimately has been shown to enhance long-term survivorship in total knee arthroplasty.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 51 - 51
1 Dec 2017
Cucchi D Compagnoni R Ferrua P Menon A Randelli P
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Patient specific instrumentation (PSI) for total knee arthroplasty (TKA) may improve component position and sizing. However, little has been reported about the accuracy of the default plan created by the manufacturer. The purpose of the study was to evaluate the reliability of the manufacturer plan and the impact of surgeon's changes on the final accuracy of the cutting guide sizes.

The planned sizes of 45 TKAs were prospectively recorded from the in the initial manufacturer's proposal and from the final plan modified after surgeon's evaluation and compared to the actually implanted sizes.

The manufacturer's initial proposal differed from the final implant in 20% of the femoral and 51.11% of the tibial components, while the surgeon's plan in 13.33% of the femoral and 26.67% of the tibial components. Surgeon's modifications in the pre-operative were carried out for 11.11% of the femoral components and 51.11% of the tibial ones (p = 0.0299). Appropriate modification occurred in of 88% and 76% of femoral and tibial changes respectively.

The surgeon's accuracy to predict the final component size was significantly different from that of the manufacturer and changes on the manufacturer's plan were necessary to get an accurate preoperative plan of the implant sizes. Careful evaluation by an experienced knee surgeon is mandatory when planning TKA with PSI. Collaboration between surgeons and manufacturers may help obtain improved accuracy in PSI size planning.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 892 - 897
1 Sep 2024
Mancino F Fontalis A Kayani B Magan A Plastow R Haddad FS

Advanced 3D imaging and CT-based navigation have emerged as valuable tools to use in total knee arthroplasty (TKA), for both preoperative planning and the intraoperative execution of different philosophies of alignment. Preoperative planning using CT-based 3D imaging enables more accurate prediction of the size of components, enhancing surgical workflow and optimizing the precision of the positioning of components. Surgeons can assess alignment, osteophytes, and arthritic changes better. These scans provide improved insights into the patellofemoral joint and facilitate tibial sizing and the evaluation of implant-bone contact area in cementless TKA. Preoperative CT imaging is also required for the development of patient-specific instrumentation cutting guides, aiming to reduce intraoperative blood loss and improve the surgical technique in complex cases. Intraoperative CT-based navigation and haptic guidance facilitates precise execution of the preoperative plan, aiming for optimal positioning of the components and accurate alignment, as determined by the surgeon’s philosophy. It also helps reduce iatrogenic injury to the periarticular soft-tissue structures with subsequent reduction in the local and systemic inflammatory response, enhancing early outcomes. Despite the increased costs and radiation exposure associated with CT-based navigation, these many benefits have facilitated the adoption of imaged based robotic surgery into routine practice. Further research on ultra-low-dose CT scans and exploration of the possible translation of the use of 3D imaging into improved clinical outcomes are required to justify its broader implementation. Cite this article: Bone Joint J 2024;106-B(9):892–897


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_12 | Pages 52 - 52
1 Oct 2018
Naudie DD Broberg JS Howard JL Vasarhelyi EM Yuan X McCalden RW Teeter MG
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Introduction

The effectiveness of patient specific instrumentation (PSI) to perform total knee arthroplasty (TKA) remains controversial. Multiple studies have been published that reveal conflicting results on the effectiveness of PSI, but no study has analyzed the contact kinematics within knee joints replaced with the use of PSI. Since a departure from normal kinematics can lead to eccentric loading, premature wear, and component loosening, studying the kinematics in patients who have undergone TKA with PSI can provide valuable insight on the ability of PSI to improve functionality and increase longevity. The goal of the present study was to compare femoral and tibial component migration (predictive of long-term loosening and revision) and contact kinematics following TKA using conventional instruments (CI) and PSI based surgical techniques.

Methods

The study was designed as a prospective, randomized controlled trial of 50 patients, with 25 patients each in the PSI and CI groups, powered for radiostereometric analysis (RSA). Patients in the PSI group received an MRI and standing 3-foot x-rays to construct patient-specific cut-through surgical guides for the femur and tibia with a mechanical limb alignment. All patients received the same posterior-stabilized implant with marker beads inserted in the bone around the implants to enable RSA imaging. Patients underwent supine RSA exams at multiple time points (two and six weeks, three and six months, and one and two years). At 2 years post-op, a series of RSA radiographs were acquired at different knee flexion angles, ranging in 20° increments from 0° to 120°, to measure the tibiofemoral contact kinematics. Migrations of the femoral and tibial components were calculated using model-based RSA software. Kinematics were measured for each condyle for magnitude of excursion, contact location, and stability.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 137 - 137
1 Jan 2016
Renson L Poilvache P Van Den Wyngaert H
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Background

Obtaining accurate alignment in total knee arthroplasty (TKA) remains a concern. Patient specific instrumentation (PSI) created using preoperative 3D modelling was developed to offer surgeons a simplified, reliable, efficient and customised TKA procedure.

Methods

In this prospective study, 60 patients who underwent TKA with conventional instrumentation and 71 patients operated on using PSI were followed for 1 year.(Table 1) The primary endpoint was surgical time. Secondary endpoints included the number of instrument trays used, radiographic limb alignment and clinical outcomes.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 116 - 116
1 Aug 2013
Confalonieri N Manzotti A Aldè S
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INTRODUCTION

Despite clear clinical advantages Unicompartimetal Knee Replacement (UKR) still remain a high demanding and less forgiving surgical procedure. Different Authors in literature pointed out how in coronal tibial malalignment beyond 3° as well as tibial slope beyond 7° increase the rate of aseptic failure. Likewise, overcorrection in the coronal plain is a well recognised cause of failure because of an overweighting on the controlateral compartment. Furthermore it has been shown how in UKR surgery even using short narrow intramedullary guide this can cause errors in both coronal planes. Computer assisted surgery has been proposed to improve implant positioning in joint replacement surgery with no need of intramedullary guide. Likewise more recently Patient Specific Instrumentation (PSI) has been suggested as a new technology capable of new advantages such as shorter surgical times and lower blood losses maintaining at least the same accuracy. Aim of this prospective study is to present comparing 2 groups of UKRs using either a computer assisted technique or a CT based PSI.

MATERIALS AND METHODS

Since January 2010 54 patients undergoing UKR because of medial compartment arthritis were prospectively enrolled in the study. Before surgery patients were alternatively assigned to either computer-assisted alignment (group A) or PSI group (group B). In the group A (27 knees) the implant (Sigma, Depuy Orthopaedics Inc, Warsaw, Indiana, USA) was positioned using a CT-free computer assisted alignment system specifically created for UKR surgery (OrthoKey, Delaware, USA USA). In group B (27knees) the implant (GMK uni, Medacta, Castel San Pietro, Switzerland) was performed using a CT-Based PSI technology (MyKnee, Medacta, Castel San Pietro, Switzerland). In both the groups all the implants were cemented and using always a fixed metal backed tibial component. The duration of surgery and all the complications according to Kim classification were documented in all cases. Six months after surgery each patient had long-leg standing anterior-posterior radiographs and lateral radiographs of the knee. The radiographs were assessed to determine the Frontal Femoral Component angle (FFC), the Frontal Tibial Component angle (FTC), the Hip-Knee-Ankle angle (HKA) and the sagittal orientation (slope) of both tibial and femoral component. The number and percentage of outliners for each parameter was determined. In addition the percentage of patients from each group with all 5 parameters within the desired range was calculated. Furthermore at the latest follow-up the 2 groups were clinically assessed using KSS and Functional score.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_5 | Pages 71 - 71
1 Mar 2017
Owyang D Dadia S Jaere M Auvinet E Brevadt MJ Cobb J
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Introduction

Clear operative oncological margins are the main target in malignant bone tumour resections. Novel techniques like patient specific instruments (PSIs) are becoming more popular in orthopaedic oncology surgeries and arthroplasty in general with studies suggesting improved accuracy and reduced operating time using PSIs compared to conventional techniques and computer assisted surgery. Improved accuracy would allow preservation of more natural bone of patients with smaller tumour margin.

Novel low-cost technology improving accuracy of surgical cuts, would facilitate highly delicate surgeries such as Joint Preserving Surgery (JPS) that improves quality of life for patients by preserving the tibial plateau and muscle attachments around the knee whilst removing bone tumours with adequate tumour margins. There are no universal guidelines on PSI designs and there are no studies showing how specific design of PSIs would affect accuracy of the surgical cuts.

We hypothesised if an increased depth of the cutting slot guide for sawblades on the PSI would improve accuracy of cuts.

Methods

A pilot drybone experiment was set up, testing 3 different designs of a PSI with changing cutting slot depth, simulating removal of a tumour on the proximal tibia (figure 1)

A handheld 3D scanner (Artec Spider, Luxembourg) was used to scan tibia drybones and Computer Aided Design (CAD) software was used to simulate osteosarcoma position and plan intentioned cuts (figure 1). PSI were designed accordingly to allow sufficient tumour. The only change for the 3 designs is the cutting slot depth (10mm, 15mm & 20mm). 7 orthopaedic surgeons were recruited to participate and perform JPS on the drybones using each design 2 times. Each fragment was then scanned with the 3D scanner and were then matched onto the reference tibia with customized software to calculate how each cut (inferior-superior-vertical) deviated from plan in millimetres and degrees (figure 3). In order to tackle PSI placement error, a dedicated 3D-printed mould was used.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 36 - 36
1 Jan 2017
Owyang D Dadia S Jaere M Auvinet E Brevadt M Cobb J
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The aim of this project is to test the parameters of Patient Specific Instruments (PSIs) and measuring accuracy of surgical cuts using sawblades with different depths of PSI cutting guide slot.

Clear operative oncological margins are the main target in malignant bone tumour resections. Novel techniques like patient specific instruments (PSIs) are becoming more popular in orthopaedic oncology surgeries and arthroplasty in general with studies suggesting improved accuracy and reduced operating time using PSIs compared to conventional techniques and computer assisted surgery. Improved accuracy would allow preservation of more natural bone of patients with smaller tumour margin. Novel low-cost technology improving accuracy of surgical cuts, would facilitate highly delicate surgeries such as Joint Preserving Surgery (JPS) that improves quality of life for patients by preserving the tibial plateau and muscle attachments around the knee whilst removing bone tumours with adequate tumour margins. There are no universal guidelines on PSI designs and there are no studies showing how specific design of PSIs would affect accuracy of the surgical cuts. We hypothesised if an increased depth of the cutting slot guide for sawblades on the PSI would improve accuracy of cuts.

A pilot drybone experiment was set up, testing 3 different designs of a PSI with changing cutting slot depth, simulating removal of a tumour on the proximal tibia. A handheld 3D scanner (Artec Spider, Luxembourg) was used to scan tibia drybones and Computer Aided Design (CAD) software was used to simulate osteosarcoma position and plan intentioned cuts. PSI were designed accordingly to allow sufficient tumour. The only change for the 3 designs is the cutting slot depth (10mm, 15mm & 20mm). 7 orthopaedic surgeons were recruited to participate and perform JPS on the drybones using each design 2 times. Each fragment was then scanned with the 3D scanner and were then matched onto the reference tibia with customized software to calculate how each cut (inferior-superior-vertical) deviated from plan in millimetres and degrees. In order to tackle PSI placement error, a dedicated 3D-printed mould was used.

Comparing actual cuts to planned cuts, changing the height of the cutting slot guide on the designed PSI did not deviate accuracy enough to interfere with a tumour resection margin set to maximum 10mm. We have obtained very accurate cuts with the mean deviations(error) for the 3 different designs were: [10mm slot: 0.76 ± 0.52mm, 2.37 ± 1.26°], [15 mm slot: 0.43 ± 0.40 mm, 1.89 ± 1.04°] and [20 mm: 0.74 ± 0.65 mm, 2.40 ± 1.78°] respectively, with no significant difference between mean error for each design overall, but the inferior cuts deviation in mm did show to be more precise with 15 mm cutting slot (p<0.05).

Simulating a cut to resect an osteosarcoma, none of the proposed designs introduced error that would interfere with the tumour margin set. Though 15mm showed increased precision on only one parameter, we concluded that 10mm cutting slot would be sufficient for the accuracy needed for this specific surgical intervention. Future work would include comparing PSI slot depth with position of knee implants after arthroplasty, and how optimisation of other design parameters of PSIs can continue to improve accuracy of orthopaedic surgery and allow increase of bone and joint preservation.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_9 | Pages 31 - 31
1 May 2016
Pierrepont J McMahon R Miles B McMahon S
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Introduction

Appropriate acetabular cup orientation is an important factor in reducing instability and maximising the performance of the bearing after Total Hip Arthroplasty (THA). However, postoperative analyses of two large cohorts in the US have shown that more than half of cups are malorientated. In addition, there is no consensus as to what inclination and anteversion angles should be targeted, with contemporary literature suggesting that the orientation should be customised for each individual patient.

The aim of this study was to measure the accuracy of a novel patient specific instrumentation system in a consecutive series of 22 acetabular cups, each with a customised orientation.

Methodology

Twenty-two consecutive total hip replacement patients were sent for Trinity Optimized Positioning System (OPS) acetabular planning (Optimized Ortho, Sydney). The Trinity OPS planning is a preoperative, dynamic analysis of each patient performing a deep flexion and full extension activity. The software calculates the dynamic force at the hip to be replaced and plots the bearing contact patch as it traces across the articulating surface. The software modelled multiple cup orientations and the alignment which best centralised the load was chosen by the surgeon from the preoperative reports. Once the target orientations had been determined, a unique patient specific guide was 3D printed and used intra-operatively with a laser guided system to achieve the planned alignment, Fig 1. All patients received a post-operative CT scan at 3 months and the radiographic cup inclination and anteversion was measured. The study was ethically approved by The Avenue Hospital Human Research Ethics Committee, Trial Number 176.


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_4 | Pages 55 - 55
1 Apr 2018
Yabuno K Sawada N Hirohaku D
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Introduction

With the development of 3D printing technology, there are many different types of PSI in the world. The accuracy of patient specific instrumentation (PSI) in primary total knee arthroplasty (TKA) is dependent on appropriate placement of the cutting blocks. However, previous reports on one type of PSI measured the difference between postoperative prosthetic alignment and postoperative mechanical axis and thus these reports did not evaluate intraoperative comparison of PSIs between two different designs. The purpose of this study was to evaluate the intraoperative accuracy of two different designed PSIs (My knee, Medacta International, Castel San Pietro, Switzerland) with two examiners using CT free navigation system (Stryker, Mahwar, NJ, USA) in regards to sagittal and coronal alignment.

Methods

We enrolled 78knees (66 patients) with a primary cemented TKA using two different designed CT-based PSIs (My knee, Medacta International, Castel San Pietro, Switzerland). All operations were performed by two senior surgeons who have experience with greater than 500 TKAs and greater than 200 navigated TKAs. Two examiners were same two surgeons. The study period was between June 2015 and November 2016. The local ethics' committee approved the study prior to its initiation, and informed consent was obtained from all patients. After placement of the PSI on the femur and tibia, the position of the PSI was evaluated by s intraoperative navigation. Two examiners placed two different types (STD(standard) and MIS(minimum invasive surgery)) of PSI on same joint. As required by the PSI, only soft- tissue was removed and osteophytes were left in place. Femoral MIS PSI was required partial remove of lateral cartilage. For the femur, the coronal position in relation to the mechanical axis were documented. For the tibia, the coronal alignment and the tibial slope were documented. Of note, intraoperative modifications to the PSI were not made based upon the results of the navigation. Rather, the findings of the intraoperative navigation were simply documented.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_16 | Pages 11 - 11
1 Oct 2014
Paul L Cartiaux O Odri G Gouin F
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Resecting bone tumours within the pelvis is highly challenging and requires good cutting accuracy to achieve sufficient margins. Computer-assisted technologies such as intraoperative navigation have been developed for pelvic bone tumour resection. Patient-specific instruments have been transposed to tumour surgery. The present study reports a series of 11 clinical cases of PSI-assisted bone tumour surgery within the pelvis, and assesses how accurately a preoperative resection strategy can be replicated intraoperatively with the PSI.

The patient series consisted in 11 patients eligible for curative surgical resection of primary bone tumor of the pelvis. Eight patients had a bone sarcoma of iliac bone involving the acetabulum, two patients had a sacral tumor, and one patient had a chondrosarcoma of proximal femur with intra-articular hip extension. Resection planning was preoperatively defined including a safe margin defined by the surgeon from 3 up to 15 mm. PSI were designed using a computer-aided design software according to the desired resection strategy and produced by additive manufacturing technology. Intraoperatively, PSI were positioned freehand by the surgeon and fixed on the bone surface using K-wires. The standard surgical approach has been used for each patient. Dissection was in accordance with the routine technique. There was no additional bone exposure to position the PSI. Histopathological analysis of the resected tumor specimens was performed to evaluate the achieved resection margins. Postoperative CT were acquired and matched to the preoperative CT to assess the local control of the tumor. Two parameters were measured: achieved resection margin (minimum distance to the tumor) and location accuracy (maximum distance between achieved and planned cuttings; ISO1101 standard).

PSI were quick and easy to use with a positioning onto the bone surface in less than 5 minutes for all cases. The positioning of the PSI was considered unambiguous for all patients. Histopathological analysis classified all achieved resection margins as R0 (tumor-free), except for two patients : R2 because of a morcelised tumour and R1 in soft tissues. The errors in safe margin averaged −0.8 mm (95% CI: −1.8 mm to 0.1 mm). The location accuracy of the achieved cut planes with respect to the desired cut planes averaged 2.5 mm (95% CI: 1.8 to 3.2 mm).

Results in terms of safe margin or the location accuracy demonstrated how PSI enabled the surgeon to intraoperatively replicate the resection strategies with a very good cutting accuracy. These findings are consistent with the levels of bone-cutting accuracy published in the literature. PSI technology described in this study achieved clear bone margins for all patients. Longer follow-up period is required but it appears that PSI has the potential to provide clinically acceptable margins.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_13 | Pages 14 - 14
1 Jun 2016
Madhusudhan T Gardner S Harvey R
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Patient specific instrumentation (PSI) for elective knee replacements in arthritic knees with severe deformities and in revision scenarios is becoming increasingly popular due to the advantage of restoring the limb axes, improved theatre efficiency and outcomes. Currently available systems use CT scan or MRI for pre-operative templating for design considerations with varied accuracy for sizing of implants.

We prospectively evaluated 200 knees in 188 patients with arthritic knees with deformities requiring serial clinical assessment, radiographs and CT scans for PSI templating for TruMatch knee system (DepuySynthes, Leeds, UK). The common indications included severe arthritic deformities, previous limb fractures and in obese limbs with difficult clinical assessment. Surgical procedure was performed on standard lines with the customised cutting blocks.

The ‘lead up’ time between the implant request and the operating date was 5 weeks on an average. We compared the pre op CT images and the best fit post-operative x- rays. The sizing accuracy for femur and tibia was 98.93 % and 95.75% respectively. All blocks fitted the femur and tibia. There were no bail outs, no cutting block breakage, 1 patient had residual deformity of 20 degrees, and 1 patient had late infection. The length of hospital stay, economic viability in terms of theatre turnover, less operating time, cost of sterilisation in comparison to conventional knee replacement surgery with other factors being unchanged was also assessed.

The projected savings was substantial along with improved geometrical restoration of the knee anatomy. We recommend the use of PSI based on CT scan templating in difficult arthritic knees.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 9 - 9
1 Jan 2016
Goyal N Stulberg SD
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Introduction

Patient specific instrumentation (PSI) generates customized guides from an MRI- or CT-based preoperative plan for use in total knee arthroplasty (TKA). PSI software executes the preoperative planning process. Several manufacturers have developed proprietary PSI software for preoperative planning. It is possible that each proprietary software has a unique preoperative planning process, which may lead to variation in preoperative plans among manufactures and thus variation in the overall PSI technology. The purpose of this study was to determine whether different PSI software generate similar preoperative plans when applied to a single implant system and given identical MR images.

Methods

In this prospective comparative study, we evaluated PSI preoperative plans generated by Materialise software and Zimmer Patient Specific Instruments software for 37 consecutive knees. All plans utilized the Zimmer Persona™ CR implant system and were approved by a single experienced surgeon blinded to the other software-generated preoperative plan. For each knee, the MRI reconstructions for both software programs were evaluated to qualitatively determine differences in bony landmark identification. The software-generated preoperative plans were assessed to determine differences in preoperative alignment, component sizes, and resection depth. PSI planned bone resection was compared to actual bone resection to assess the accuracy of intraoperative execution.


The final alignment of Patient Specific Instrumentation (PSI) TKA relies on the accuracy and the correct placement of the 3-D moulds, precision of saw cuts, soft tissue balancing and cementing technique. We aimed to compare the predicted alignment between PSI and Articulated Surface Mounted (ASM) computer navigation. Eight consecutive patients underwent knee replacement using MRI based PSI (Zimmer) with planning of 0º femoral and tibial mechanical alignment. After placing the conventional cutting blocks over the pins (placed according to PSI), the predicted alignment of cuts was verified with ASM navigation. PSI technique was used regardless of navigation values and alignment was compared.

Good correlation was found for tibial cuts (maximum variation: coronal plane – 1º, sagittal plane – 2º) and femoral cuts in the sagittal plane (maximum variation 2º). However, in two patients the coronal plane variation in femur was > 2º (3º and 4º respectively). Navigation predicted combined final alignment of 5º valgus and 4º valgus in these patients. However, long leg standing x-rays revealed neutral and 1º valgus alignment in those two patients respectively, matching closely with PSI prediction. Final alignment in long-leg standing x-rays were independently reported by a musculoskeletal radiologist. Six knees were in neutral mechanical alignment (including the 2 navigation predicted outliers). The remaining 2 knees had a maximum deviation of 2 degrees from neutral. We conclude that there was overall good correlation between PSI and navigation. Even in cases where navigation predicted more than 3º combined varus/valgus alignment, PSI prediction was more accurate on long leg views.


Bone & Joint 360
Vol. 10, Issue 5 | Pages 21 - 24
1 Oct 2021


Bone & Joint Research
Vol. 11, Issue 1 | Pages 23 - 25
17 Jan 2022
Matar HE Platt SR Bloch BV Board TN Porter ML Cameron HU James PJ


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1449 - 1456
1 Sep 2021
Kazarian GS Lieberman EG Hansen EJ Nunley RM Barrack RL

Aims

The goal of the current systematic review was to assess the impact of implant placement accuracy on outcomes following total knee arthroplasty (TKA).

Methods

A systematic review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines using the Ovid Medline, Embase, Cochrane Central, and Web of Science databases in order to assess the impact of the patient-reported outcomes measures (PROMs) and implant placement accuracy on outcomes following TKA. Studies assessing the impact of implant alignment, rotation, size, overhang, or condylar offset were included. Study quality was assessed, evidence was graded (one-star: no evidence, two-star: limited evidence, three-star: moderate evidence, four-star: strong evidence), and recommendations were made based on the available evidence.


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 10 - 10
1 May 2019
Iannotti J
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Introduction

The degree of glenoid bone loss associated with primary glenohumeral osteoarthritis can influence the type of glenoid implant selected and its placement in total shoulder arthroplasty (TSA). The literature has demonstrated inaccurate glenoid component placement when using standard instruments and two-dimensional (2D) imaging without templating, particularly as the degree of glenoid deformity or bone loss worsens. Published results have demonstrated improved accuracy of implant placement when using three-dimensional (3D) computed tomography (CT) imaging with implant templating and patient specific instrumentation (PSI). Accurate placement of the glenoid component in TSA is expected to decrease component malposition and better correct pathologic deformity in order to decrease the risk of component loosening and failure over time. Different types of PSI have been described. Some PSI use 3D printed single use disposable instrumentation, while others use adjustable and reusable-patient specific instrumentation (R-PSI). However, no studies have directly compared the accuracy of different types of PSI in shoulder arthroplasty. We combined our clinical experience and compare the accuracy of glenoid implant placement with five different types of instrumentation when using 3D CT imaging, preoperative planning and implant templating in a series of 173 patients undergoing primary TSA. Our hypothesis was that all PSI technologies would demonstrate equivalent accuracy of implant placement and that PSI would show the most benefit with more severe glenoid deformity.

Discussion and Conclusions

We demonstrated no consistent differences in accuracy of 3D CT preoperative planning and templating with any type of PSI used. In Groups 1 and 2, standard instrumentation was used in a patient specific manner defined by the software and in Groups 3, 4, and 5 a patient specific instrument was used. In all groups, the two surgeons were very experienced with use of the 3D CT preoperative planning and templating software and all of the instrumentation prior to starting this study, as well as very experienced with shoulder arthroplasty. This is a strength of the study when defining the efficacy of the technology, but limits the generalizability of the findings when considering the effectiveness of the technology with surgeons that may not have as much experience with shoulder arthroplasty and/or the PSI technology. Conversely, it could be postulated that greater improvements in accuracy may be seen with the studied PSI technology, when compared to no 3D planning or PSI, with less experienced surgeons. There could also be differences between the PSI technologies when used by less experienced surgeons, either across all cases or based upon the severity of pathology. When the surgeon is part of the method, the effectiveness of the technology is equally dependent upon the surgeon using the technology. A broader study using different surgeons is required to test the effectiveness of this technology. Comparing the results of this study with published results in the literature, 3D CT imaging and implant templating with use of PSI results in more accurate placement of the glenoid implant when compared to 2D CT imaging without templating and use of standard instrumentation. In previous studies, this was most evident in patients with more severe bone deformity. We believe that 3D CT planning and templating provides the most value in defining the glenoid pathology, as well as in the selection of the optimal implant and its placement. However, it should be the judgment of the surgeon, based upon their experience, to select the instrumentation to best achieve the desired result.


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 56 - 63
1 Jan 2015
Abane L Anract P Boisgard S Descamps S Courpied JP Hamadouche M

In this study we randomised 140 patients who were due to undergo primary total knee arthroplasty (TKA) to have the procedure performed using either patient-specific cutting guides (PSCG) or conventional instrumentation (CI).

The primary outcome measure was the mechanical axis, as measured at three months on a standing long-leg radiograph by the hip–knee–ankle (HKA) angle. This was undertaken by an independent observer who was blinded to the instrumentation. Secondary outcome measures were component positioning, operating time, Knee Society and Oxford knee scores, blood loss and length of hospital stay.

A total of 126 patients (67 in the CI group and 59 in the PSCG group) had complete clinical and radiological data. There were 88 females and 52 males with a mean age of 69.3 years (47 to 84) and a mean BMI of 28.6 kg/m2 (20.2 to 40.8). The mean HKA angle was 178.9° (172.5 to 183.4) in the CI group and 178.2° (172.4 to 183.4) in the PSCG group (p = 0.34). Outliers were identified in 22 of 67 knees (32.8%) in the CI group and 19 of 59 knees (32.2%) in the PSCG group (p = 0.99). There was no significant difference in the clinical results (p = 0.95 and 0.59, respectively). Operating time, blood loss and length of hospital stay were not significantly reduced (p = 0.09, 0.58 and 0.50, respectively) when using PSCG.

The use of PSCG in primary TKA did not reduce the proportion of outliers as measured by post-operative coronal alignment.

Cite this article: Bone Joint J 2015;97-B:56–63.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 12 - 12
1 Jul 2014
Hurst J
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Anatomic and accurate placement of components is a primary goal in all arthroplasty procedures. Unique to total shoulder arthroplasty, challenging glenoid exposure and osteoarthritic glenoid deformity offer significant challenges and impediments to this goal. Despite thorough pre-operative planning strategies and contemporary cannulated pin-based shoulder systems, it is often times still difficult to accurately aim the guide pin to the medial border of the scapula when the deformity is substantial or exposure is difficult. Even small errors in guide pin position can result in problems with final component version, inclination and glenoid vault perforation. In addition, a malpositioned glenoid component has been shown to have a negative impact on implant longevity and clinical performance.

Image-based patient specific instrumentation has been available in the lower extremity for nearly a decade with reliable results. The application of similar technology in the shoulder has demonstrated reliable positioning of the guide pin to a pre-operative plan with subsequent accurate placement of the glenoid component. This surgical demonstration will feature one of the currently available CT-based patient specific glenoid guides using a standard deltopectoral approach.


Bone & Joint 360
Vol. 13, Issue 1 | Pages 35 - 38
1 Feb 2024

The February 2024 Oncology Roundup. 360. looks at: Does primary tumour resection improve survival for patients with sarcomas of the pelvis with metastasis at diagnosis?; Proximal femur replacements for an oncologic indication offer a durable endoprosthetic reconstruction option: a 40-year experience; The importance of awaiting biopsy results in solitary pathological proximal femoral fractures: do we need to biopsy solitary pathological fractures?; Effect of radiotherapy on local recurrence, distant metastasis, and overall survival in 1,200 extremity soft-tissue sarcoma patients; What to choose in bone tumour resections? Patient-specific instrumentation versus surgical navigation; Optimal timing of re-excision in synovial sarcoma patients: immediate intervention versus waiting for local recurrence; Survival differences of patients with resected extraskeletal osteosarcoma receiving two different (neo) adjuvant chemotherapy regimens; Solitary versus multiple bone metastases in the appendicular skeleton: should the surgical treatment be different?


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1270 - 1276
1 Jul 2021
Townshend DN Bing AJF Clough TM Sharpe IT Goldberg A

Aims. This is a multicentre, non-inventor, prospective observational study of 503 INFINITY fixed bearing total ankle arthroplasties (TAAs). We report our early experience, complications, and radiological and functional outcomes. Methods. Patients were recruited from 11 specialist centres between June 2016 and November 2019. Demographic, radiological, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Questionnaire, and EuroQol five-dimension five-level score) were collected preoperatively, at six months, one year, and two years. The Canadian Orthopaedic Foot and Ankle Society (COFAS) grading system was used to stratify deformity. Early and late complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts, and/or subsidence. Results. In all, 500 patients reached six-month follow-up, 420 reached one-year follow-up, and 188 reached two-year follow-up. The mean age was 67.8 years (23.9 to 88.5). A total of 38 patients (7.5%) presented with inflammatory arthritis. A total of 101 (20.0%) of implantations used patient-specific instrumentation; 167 patients (33.1%) underwent an additional procedure at the time of surgery. A total of seven patients died of unrelated causes, two withdrew, and one was lost to follow-up. The mean follow-up was 16.2 months (6 to 36). There was a significant improvement from baseline across all functional outcome scores at six months, one, and two years. There was no significant difference in outcomes with the use of patient-specific instrumentation, type of arthritis, or COFAS type. Five (1.0%) implants were revised. The overall complication rate was 8.8%. The non-revision reoperation rate was 1.4%. The 30-day readmission rate was 1.2% and the one-year mortality 0.74%. Conclusion. The early experience and complications reported in this study support the current use of the INFINITY TAA as a safe and effective implant in the treatment of end-stage ankle arthritis. Cite this article: Bone Joint J 2021;103-B(7):1270–1276


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_13 | Pages 55 - 55
1 Nov 2015
Lee G
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Introduction. Proposed advantages of patient-specific instrumentation in total knee arthroplasty (TKA) include enhanced accuracy for component positioning, reduced operative time, and increased OR efficiency leading to potential cost savings. However, various studies with relatively small sample sizes have evaluated the impact of these custom cutting guides and were unable to detect any significant differences compared to conventional surgical technique. Therefore, the purpose of this study is to improve the sensitivity of investigation through meta-analysis and compare patient-specific versus standard TKA instrumentation with regard to: (1) coronal alignment, (2) sagittal alignment, (3) operative time, (4) blood loss, (5) transfusion requirement, and (6) peri-operative costs. Methods. A systematic review of the peer-reviewed literature indexed on Medline and/or Embase was performed in search of Level I, II, or III studies comparing the results of patient-specific versus standard TKA instrumentation. Nine studies remained following the screening process. The data published in these studies were extracted and aggregated for the purpose of comparing the two treatment groups with regard to coronal alignment, sagittal alignment, operative time, blood loss, transfusion requirement, and peri-operative costs. Using previously published data, it was determined that a sample size of 80 patients per group would have sufficient power (0.80) to detect a significant difference (α = 0.05) in all primary outcomes. Results. The nine component studies described a total of 957 total knee arthroplasties (529 performed with patient-specific instrumentation and 428 with standard instrumentation). While patient-specific instrumentation demonstrated improved accuracy in coronal alignment as measured by femorotibial angle (FTA) (p = 0.0003), standard instrumentation demonstrated improved accuracy in coronal alignment as measured by hip-knee-ankle (HKA) (p = 0.02). Importantly, there were no significant differences in the ability of either technique to avoid outliers (+ or – 3 degrees of target alignment) in either FTA or HKA. Measures of sagittal alignment accuracy were equivalent between the two groups for both the femoral component (p = 0.5) and the tibial component (p = 0.9). Operative time (92.5 minutes vs. 104.1 minutes, p = 0.1), blood loss (371 mL vs. 384 mL, p = 0.2), and transfusion requirement (10.1% vs. 14.1%, p = 0.1) were also similar between treatment groups. The three studies that compared costs (307 TKAs) found decreased peri-operative costs associated with patient-specific instrumentation as a result of increased OR efficiency, but these costs were offset by the expenditures related to producing the custom instrumentation. Discussion and Conclusion. Patient-specific instrumentation does not demonstrate superiority over standard instrumentation with regard to coronal or sagittal alignment. In addition, operative time, blood loss, and transfusion requirement are similar between techniques. Finally, while patient-specific instrumentation can lead to cost savings through improved OR efficiencies, these costs are often offset by the cost of generating the custom instrumentation. Therefore, current data does not support routine use of patient-specific instrumentation during primary TKA


The Bone & Joint Journal
Vol. 102-B, Issue 3 | Pages 365 - 370
1 Mar 2020
Min KS Fox HM Bedi A Walch G Warner JJP

Aims. Patient-specific instrumentation has been shown to increase a surgeon’s precision and accuracy in placing the glenoid component in shoulder arthroplasty. There is, however, little available information about the use of patient-specific planning (PSP) tools for this operation. It is not known how these tools alter the decision-making patterns of shoulder surgeons. The aim of this study was to investigate whether PSP, when compared with the use of plain radiographs or select static CT images, influences the understanding of glenoid pathology and surgical planning. Methods. A case-based survey presented surgeons with a patient’s history, physical examination, and, sequentially, radiographs, select static CT images, and PSP with a 3D imaging program. For each imaging modality, the surgeons were asked to identify the Walch classification of the glenoid and to propose the surgical treatment. The participating surgeons were grouped according to the annual volume of shoulder arthroplasties that they undertook, and responses were compared with the recommendations of two experts. Results. A total of 59 surgeons completed the survey. For all surgeons, the use of the PSP significantly increased agreement with the experts in glenoid classification (x. 2. = 8.54; p = 0.014) and surgical planning (x. 2. = 37.91; p < 0.001). The additional information provided by the PSP also showed a significantly higher impact on surgical decision-making for surgeons who undertake fewer than ten shoulder arthroplasties annually (p = 0.017). Conclusions. The information provided by PSP has the greatest impact on the surgical decision-making of low volume surgeons (those who perform fewer than ten shoulder arthroplasties annually), and PSP brings all surgeons in to closer agreement with the recommendations of experts for glenoid classification and surgical planning. Cite this article: Bone Joint J 2020;102-B(3):365–370


Bone & Joint 360
Vol. 13, Issue 1 | Pages 19 - 22
1 Feb 2024

The February 2024 Foot & Ankle Roundup. 360. looks at: Survival of revision ankle arthroplasty; Tibiotalocalcaneal nail for the management of open ankle fractures in the elderly patient; Accuracy of a patient-specific total ankle arthroplasty instrumentation; Fusion after failed primary ankle arthroplasty: can it work?; Treatment options for osteochondral lesions of the talus; Managing hair tourniquet syndrome of toe: a rare emergency; Ultrasound-guided collagenase therapy for recurrent plantar fibromatosis: a promising line of therapy?


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 83 - 83
1 Jul 2022
Dandridge O Garner A Amis A Cobb J Arkel RV
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Abstract. Patellofemoral Arthroplasty (PFA) is an alternative to TKA for patellofemoral osteoarthritis that preserves tibiofemoral compartments. It is unknown how implant positioning affects biomechanics, especially regarding the patella. This study analysed biomechanical effects of femoral and patellar component position, hypothesising femoral positioning is more important. Nine cadaveric knees were studied using a repeated-measures protocol. Knees were tested intact, then after PFA implanted in various positions: neutral (as-planned), patellar over/understuffing (±2mm), patellar tilt, patellar flexion, femoral rotation, and femoral tilt (all ±6°). Arthroplasties were implemented with CT-designed patient-specific instrumentation. Anterior femoral cuts referenced Whiteside's line and all femoral positions ensured smooth condyle-to-component transition. Knee extension moments, medial patellofemoral ligament (MPFL) length-change, and tibiofemoral and patellofemoral kinematics were measured under physiological muscle loading. Data were analysed with one-dimensional statistical parametric mapping (Bonferroni-Holm corrected). PFA changed knee function, altering extension moments (p<0.001) and patellofemoral kinematics (p<0.05), but not tibiofemoral kinematics. Patellar component positioning affected patellofemoral kinematics: over/understuffing influenced patellar anterior translation and the patellar tendon moment arm (p<0.001). Medially tilted patellar cuts produced lateral patellar tilt (p<0.001) and vice versa. A similar inverse effect occurred with extended/flexed patellar cuts, causing patellar flexion and extension (p<0.001), respectively. Of all variants, only extending the patellar cut produced near-native extension moments throughout. Conversely, the only femoral effect was MPFL length change between medially/laterally rotated components. PFA can restore native knee biomechanics. Provided anterior femoral cuts are controlled and smooth condyle-to-component transition assured, patellar position affects biomechanics more than femoral, contradicting the hypothesis


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_14 | Pages 3 - 3
1 Dec 2022
Leardini A Caravaggi P Ortolani M Durante S Belvedere C
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Among the advanced technology developed and tested for orthopaedic surgery, the Rizzoli (IOR) has a long experience on custom-made design and implant of devices for joint and bone replacements. This follows the recent advancements in additive manufacturing, which now allows to obtain products also in metal alloy by deposition of material layer-by-layer according to a digital model. The process starts from medical image, goes through anatomical modelling, prosthesis design, prototyping, and final production in 3D printers and in case post-production. These devices have demonstrated already to be accurate enough to address properly the specific needs and conditions of the patient and of his/her physician. These guarantee also minimum removal of the tissues, partial replacements, no size related issues, minimal invasiveness, limited instrumentation. The thorough preparation of the treatment results also in a considerable shortening of the surgical and of recovery time. The necessary additional efforts and costs of custom-made implants seem to be well balanced by these advantages and savings, which shall include the lower failures and revision surgery rates. This also allows thoughtful optimization of the component-to-bone interfaces, by advanced lattice structures, with topologies mimicking the trabecular bone, possibly to promote osteointegration and to prevent infection. IOR's experience comprises all sub-disciplines and anatomical areas, here mentioned in historical order. Originally, several systems of Patient-Specific instrumentation have been exploited in total knee and total ankle replacements. A few massive osteoarticular reconstructions in the shank and foot for severe bone fractures were performed, starting from mirroring the contralateral area. Something very similar was performed also for pelvic surgery in the Oncology department, where massive skeletal reconstructions for bone tumours are necessary. To this aim, in addition to the standard anatomical modelling, prosthesis design, technical/technological refinements, and manufacturing, surgical guides for the correct execution of the osteotomies are also designed and 3D printed. Another original experience is about en-block replacement of vertebral bodies for severe bone loss, in particular for tumours. In this project, technological and biological aspects have also been addressed, to enhance osteointegration and to diminish the risk of infection. In our series there is also a case of successful custom reconstruction of the anterior chest wall. Initial experiences are in progress also for shoulder and elbow surgery, in particular for pre-op planning and surgical guide design in complex re-alignment osteotomies for severe bone deformities. Also in complex flat-foot deformities, in preparation of surgical corrections, 3D digital reconstruction and 3D printing in cheap ABS filaments have been valuable, for indication, planning of surgery and patient communication; with special materials mimicking bone strength, these 3D physical models are precious also for training and preparation of the surgery. In Paediatric surgery severe multi planar & multifocal deformities in children are addressed with personalized pre-op planning and custom cutting-guides for the necessary osteotomies, most of which require custom allografts. A number of complex hip revision surgeries have been performed, where 3D reconstruction for possible final solutions with exact implants on the remaining bone were developed. Elective surgery has been addressed as well, in particular the customization of an original total ankle replacement designed at IOR. Also a novel system with a high-tibial-osteotomy, including a custom cutting jig and the fixation plate was tested. An initial experience for the design and test of custom ankle & foot orthotics is also in progress, starting with 3D surface scanning of the shank and foot including the plantar aspect. Clearly, for achieving these results, multi-disciplinary teams have been formed, including physicians, radiologists, bioengineers and technologists, working together for the same goal


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_16 | Pages 47 - 47
1 Oct 2016
Halai M Jamal B Robinson P Qureshi M Kimpton J Syme B McMillan J Holt G
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Three distal femoral axes have been described to aid in alignment of the femoral component; the Trans Epicondylar Axis (TEA), the Posterior Condylar Axis (PCA) and the Antero Posterior (AP) axis. Our aim was to identify if there was a reproducible relationship between the axes which would aid alignment of the femoral component. This is the first study compare all three distal femoral axes with each other using magnetic resonance imaging (MRI) in a Caucasian population. Our sample group represents real life patients awaiting total knee arthroplasty (TKA), as opposed non-arthritic or cadaveric knees. We identified the relationship between these rotational axes by performing MRI scans on 89 patients awaiting TKA with patient-specific instrumentation. Measurements were taken by two observers. Patients had a mean age of 62.5 years (range 32–91). 51 patients were female. The mean angle between the TEA and the AP axis was 92.78° with a standard deviation of 2.51° (range 88° – 99°). The mean angle between the AP axis and the PCA was 95.43° with a standard deviation of 2.75° (range 85° – 105°). The mean angle between the TEA and the PCA was 2.78° with a standard deviation of 1.91° (range 0° – 10°). We conclude that while there is a reproducible relationship between the differing femoral axes, there is a significant range in the relationship between the femoral axes. This range may lead to greater inaccuracy than has previously been appreciated when defining the rotation of the femoral component. There is most variation between the PCA and the AP axis. The TEA's relationship with the PCA and AP appears important in defining rotation. Due to the well accepted difficulty in defining the TEA intra-operatively, there may be a role for patient-specific instrumentation in TKA surgery with pre-operative MRI


The Bone & Joint Journal
Vol. 96-B, Issue 7 | Pages 857 - 862
1 Jul 2014
Abdel MP Oussedik S Parratte S Lustig S Haddad FS

Substantial healthcare resources have been devoted to computer navigation and patient-specific instrumentation systems that improve the reproducibility with which neutral mechanical alignment can be achieved following total knee replacement (TKR). This choice of alignment is based on the long-held tenet that the alignment of the limb post-operatively should be within 3° of a neutral mechanical axis. Several recent studies have demonstrated no significant difference in survivorship when comparing well aligned versus malaligned TKRs. Our aim was to review the anatomical alignment of the knee, the historical and contemporary data on a neutral mechanical axis in TKR, and the feasibility of kinematically-aligned TKRs. . Review of the literature suggests that a neutral mechanical axis remains the optimal guide to alignment. Cite this article: Bone Joint J 2014;96-B:857–62


Bone & Joint 360
Vol. 3, Issue 5 | Pages 12 - 16
1 Oct 2014

The October 2014 Knee Roundup. 360 . looks at: microfracture equivalent to OATS; examination better than MRI in predicting hamstrings re-injury; a second view on return to play with hamstrings injuries; dislocation risks in the Oxford Unicompartmental Knee; what about the tibia?; getting on top of lateral facet pain post TKR; readmission in TKR; patient-specific instrumentation; treating infrapatellar saphenous neuralgia; and arthroscopy in the middle-aged


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 57 - 57
1 Sep 2012
Goldberg T Curry WT Qin Q
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Introduction. Multiple techniques exist for performance of Total Knee Arthroplasty (TKA). In April 2010, MyKnee® Patient-Specific Instrumentation (Medacta International, SA, Castel San Pietro, Switzerland) was approved for use in TKA in the United States. The present retrospective study seeks to evaluate early results of this technique. 29 consecutive patients (30 consecutive TKA operations) underwent TKA using the MyKnee cutting-blocks. These results were compared to 30 consecutive patients utilizing Standard TKA method. The findings represent the author's first MyKnee patients, and thus early learning curve for this technique. IRB approval for retrospective research was obtained prior to the evaluation of the data. Methods. 30 consecutive patients (14 males, 16 females) underwent TKA using the MyKnee technique. Pre-operative long-standing radiographs were taken and compared to 6-week post-operative radiographs. Intraoperative data includes the femoral and tibial resections thickness: Distal Medial femoral, Distal Lateral femoral, Posterior Medial Femoral, Posterior Lateral femoral, Medial Tibia, and Lateral Tibia. These were compared to the Planned vs. Actual resections. Tourniquet time was recorded as a measure of speed of surgery. These were compared to 30 consecutive patients using Conventional TKA technique. Intraoperative complications were also recorded. Results. For the MyKnee group, 21 patients had pre-operative varus deformities with a mechanical alignment of 7.8° (range 1.2°-15.2°). 7 patients had Pre-operative valgus deformities averaging 6.9° (range 1.3°-14.5°). 2 patients were neutral. Post-operative alignment for all patients (n=23) was varus 1.92° (range 0°-5.8°). 78% of patients were within 3° and 97% of patients were within 3.6°. Only 1 patient was outside 3.6°, measuring 5.4° valgus (Figure 3). In comparison, the Standard TKA group had 21 patients with pre-operative varus deformities averaging 7.3° (range 0°-16.5°) while 7 knees were valgus 6.3° (range 1.2°-10.6°) and one was neutral. Post-operative alignment for these patients measured varus 1.85°. 79% of patients were within 3°; however the outliers were much more dramatic ranging 3.5°-9.2°. 30 Femora and 21 Tibial resections were available for review using the MyKnee technique. The Actual vs. Planned resections for the Distal Medial Femoral resection was 9.5 vs. 9.1mm respectively. Further Actual vs. Planned Femoral resections include Distal Lateral Femoral 8.4 vs. 6.3mm; Posterior Medial Femoral 9.3 vs. 9.5mm; and Posterior Lateral Femoral 8.6 vs. 7.0mm. The Actual vs. Planned Tibial resections recorded include Medial 6.07 vs. 6.29mm and Lateral 9.36 vs. 8.19mm. Statistically, there is no significant difference in post-op degree (1.85° vs. 1.92°). Tourniquet time (TT) averaged 32.97 minutes in the Standard TKA group vs. 37.03 minutes in the MyKnee group, which isn't significantly different. However, the final 15 MyKnee patients had an average time of 33.46 minutes. EBL was minimal each cohort. No intraoperative complications were recorded in either group. Discussion. Many techniques exist for performance of TKA. The present study shows definitively that Intraoperative resections and Post-operative alignments can be accurately achieved with pre-operative CT planning and using Patient-Specific Instrumentation. In conclusion, using Patient-Specific Instrumentation is safe, quick, and accurate in performance of TKA


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_10 | Pages 3 - 3
1 May 2016
Elson L Leone W Roche M Anderson C
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Introduction. The rate of technological innovation in procedural total knee arthroplasty has left little time for critical evaluation of a new technology before the adoption of even newer modalities. With more drastic financial restrictions being placed on operating room spending, orthopaedic surgeons are now required to provide excellent results on a budget. It is integral that both clinical efficacy and cost-effectiveness of these intraoperative technologies be fully understood in order to provide patients with effectual, economically conscious care. The purpose of this qualitative analysis of literature was to evaluate clinical and economic efficacy of the three most prominent technologies currently used in TKA: computer navigation, patient-specific instrumentation, and kinetic sensors. Methods. Three hundred and ninety one publications were collected; 100 were included in final qualitative analysis. Criteria for inclusion in the analysis was defined only insofar as that each piece assessed one of the above listed aspects of the three technologies Literature included in the final evaluation contained background information on each respective technology, clinical outcomes, revision rates, and/or cost analyses. All comparisons were conducted in a strictly qualitative manner, and no attempts were made to conduct interstudy statistical analyses due to the high level of variability in methodology and data collected. Results. Navigation. Navigation was designed to reduce alignment and component positioning outliers. Many surgeons have argued that its results are no better than that achieved by manual techniques. Some studies have shown that clinical outcomes have improved in navigated TKA patients, but an abundance of research suggests that this is not the case. In consideration of the expense of this technology, coupled with inconclusive results, navigation does not, at this time, seem to fit the schema for significantly reducing the rate of revision and operative cost. PSI. Patient-specific instrumentation was designed to reduce the expense of navigation systems, simplify computer-assisted methods, and improve functional outcomes. However, a majority of research has suggested that PSI is either no better, or even worse, at alignment accuracy than manual techniques. Very few publications have been able to attest to any significant increase in functional outcomes scores of PSI patients, over the scores of navigation or manual TKA. Kinetic Sensors. Kinetic sensor technology has been engineered to quantify soft-tissue balance, improve rotational alignment, and decrease the risk of post-operative complications. Albeit a young device, the sparse literature that exists shows promising results. The margin of error for detecting loads has been shown to be low, the sensors have successfully measured subtle imbalance that leads to altered gait kinematics, and has shown significant improvement in several patient-reported outcomes measures in balanced patients. Discussion. This review shows that not all modalities are created equal, and demonstrates that the cost of some technologies may not yield a clinical or time-saving payoff for the patient and hospital. While kinetic sensor devices seem to be the most promising modality, more research will be necessary to confirm its advantages over time. But, great care must be taken when adopting any novel technology; “new” does not always mean “improved”


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 48 - 48
1 Oct 2012
Goldberg T Curry W Qing Q
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In May 2010, MyKnee® patient-specific instrumentation was approved for use in this procedure in the USA. This technique uses a pre-operative CT scan of the lower extremity to plan the surgery. Images of the hip, knee, and ankle are reconstructed digitally to assess pre-operative deformity as well as size of the knee. Surgery is then planned with the goals of restoring a neutral mechanical axis of limb and providing correct sizing and placement of implants after the surgery. From this plan, patient-specific jigs are created to perform the surgery achieving the planned result without sacrificing speed of surgery or increasing complexity of the procedure. The present study seeks to evaluate both intraoperative and radiographic results of this procedure. IRB approval for retrospective research was obtained prior to evaluation of the data. Thirty consecutive patients (14 males, 16 females) underwent TKA using the MyKnee technique by the senior author. Pre-operative long-standing radiographs were taken and compared to 6-week post-operative radiographs. Intraoperative data includes the femoral and tibial resection thickness: distal medial femoral, distal lateral femoral, posterior medial femoral, posterior lateral femoral, medial tibia, and lateral tibia. These were compared to the planned vs. actual resections. Tourniquet time was recorded as a measure of speed of surgery. These were compared to 30 consecutive patients using standard TKA technique by the same author. Intraoperative complications were also recorded. For patients with varus pre-operative deformities (n = 21), the mechanical alignment was 7.8° (range 1.2° to 15.2°). Seven patients had pre-operative valgus deformities averaging 6.93° (range 1.3° to 14.5°). Two patients were neutral. Post-operative alignment for all patients (n = 30) was varus 1.92° (range 0° to 5.8°). Seventy-eight percent of patients were within 3° and 97% of patients were within 3.6°. In comparison, post-operative alignment for standard TKA patients measured varus 1.85°, which was not statistically significant. Seventy-nine percent of patients were within 3°; however the outliers were more dramatic ranging 3.5° to 9.2°. Thirty femoral and 21 tibial resections were available for review using the MyKnee technique. The actual vs. planned resections for the distal medial femoral resection was 9.5 vs. 9.1mm respectively. Further actual vs. planned femoral resections include distal lateral femoral 8.4 vs. 6.3mm; posterior medial femoral 9.3 vs. 9.5mm; and posterior lateral femoral 8.6 vs. 7.0mm. The actual vs. planned tibial resections recorded include medial 6.07 vs. 6.29mm and lateral 9.36 vs. 8.19mm. Tourniquet time averaged 32.97 minutes (range 25 to 54) in the standard TKA group vs. 37.03 minutes (range 1 to 71) in the MyKnee group. This difference was not significant. However, the final 15 MyKnee patients had an average time of 33.46 minutes. No intraoperative complications occurred. Many techniques exist for performance of TKA. Patient-specific cutting blocks allow the surgeon to pre-operatively determine resection depths, rotations, alignment, and sizing prior to the operative procedure itself. The present study shows that intraoperative resections and post-operative alignments can be accurately achieved with pre-operative CT planning and using patient-specific instrumentation. For the typical varus knee deformity, cartilage will exist on the lateral side of the knee. This can cause measurement error when measuring the lateral compartments as the CT scan is based on bone only. This can be seen in 2.1mm and 1.6mm differences in the distal lateral femoral and posterior lateral femoral resections respectively. Thus, this difference can be explained by the false measurement of intact cartilage. More accurate results could be obtained if the cartilage was removed and bone measured. Valgus knees, being diseased in the lateral compartment, did not show such variance as expected in planned vs. actual resections. Intraoperative speed of surgery is important to all participants in TKA: surgeon, hospital, and patient. Obviously accuracy should not be sacrificed for speed so it is important for any new technology introduced to the market to accelerate surgery not compromise results. In the current study, the average times of MyKnee vs. standard TKA surgery were comparative and not significantly different using a two-sample T-test. The standard TKA average tourniquet time may appear faster than other reported literature; however the surgeon is on the end of learning curve with the system. The MyKnee average tourniquet time represents the initial procedures in the learning curve and can be considered slower than what they will eventually be as the author gains more experience with the technique. Efficiency was demonstrated with the decrease in tourniquet time for the last 15 patients. Furthermore, the goals of surgery were maintained radiographically. Regardless of the deformity, the patient's post-operative mechanical axes averaged 1.85° for standard technique and 1.92° for the MyKnee group, not statistically significantly different. These results were obtained via long-standing x-rays, which are well known to be prone to error in alignment secondary to potential flexion and rotation of the extremity. The standardised protocol for acquisition of the X-ray, attempts to prevent these errors and X-rays are routinely re-done if the technician feels error has occurred. The technique also appears safe as no intra-operative complications occurred and were recognised within the first six weeks post-operative. In conclusion, using patient-specific instrumentation (MyKnee) is safe, quick, and accurate in performance of TKA


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 24 - 24
1 Jul 2020
Di Laura A Henckel J Belzunce M Hothi H Hart A
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Introduction. The achieved anteversion of uncemented stems is to a large extent limited by the internal anatomy of the bone. A better understanding of this has recently become an unmet need because of the increased use of uncemented stems. We aimed to assess plan compliance in six degrees of freedom to evaluate the accuracy of PSI and guides for stem positioning in primary THAs. Materials and Methods. We prospectively collected 3D plans generated from preoperative CTs of 30 consecutive THAs (17 left and 13 right hips), in 29 patients with OA, consisting of 16 males and 13 females (median age 68 years, range 46–83 years). A single CT-based planning system and cementless type of implant were used. Post operatively, all patients had a CT scan which was reconstructed using state-of-the-art software solution: the plan and CT reconstruction models were. Outcome measures: 1) discrepancy between planned and achieved stem orientation angles Fig.2&3; 2) clinical outcome. Results. 1) The mean (±SD) discrepancy was low for: Varus-valgus −1.1 ± 1.4 deg (IQR −2.2 – 0.3 deg); Anterior-posterior 0.1 ± 1.6 deg (IQR −0.7 – 1.3 deg). The discrepancy was higher for femoral version −1.4 ± 8.2 deg (IQR −8.3 – 7.2 deg). 3D-CT planning correctly predicted sizes in 93% of the femoral components. 2) There was no intra-operative fracture, no case showed evidence of early periprosthetic osseous injury. Discussion. Surgeons and engineers should be cautious with their expectation of achieving the planned femoral stem version of an uncemented femoral stem from the pre-operative 3D-CT plan. Conclusion. This is the first study to 3D-mensionally evaluate 3D-printed patient-specific instrumentation and guides for achieved femoral stem component orientation vis-à-vis to the plan. The tools allow accurate implant orientation, however there is still potential for improvement. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 83 - 83
1 Feb 2020
Shimmin A Pierrepont J Bare J McMahon S
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Introduction & aims. Apparently well-orientated total hip replacements (THR) can still fail due to functional component malalignment. Previously defined “safe zones” are not appropriate for all patients as they do not consider an individual's spinopelvic mobility. The Optimized Positioning System, OPS. TM. (Corin, UK), comprises preoperative planning based on a patient-specific dynamic analysis, and patient-specific instrumentation for delivery of the target component alignment. The aim of this study was to determine the early revision rate from the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) for THRs implanted using OPS. TM. . Method. Between January 4. th. 2016 and December 20. st. 2017, a consecutive series of 841 OPS. TM. cementless total hip replacements were implanted using a Trinity acetabular cup (Corin, UK) with either a TriFit TS stem (98%) or a non-collared MetaFix stem (2%). 502 (59%) procedures were performed through a posterior approach, and 355 (41%) using the direct superior approach. Mean age was 64 (range; 27 to 92) and 51% were female. At a mean follow-up of 15 months (range; 3 to 27), the complete list of 857 patients was sent to the AOANJRR for analysis. Results. There were 5 revisions: . a periprosthetic femoral fracture at 1-month post-op in a 70F. a ceramic head fracture at 12-months post-op in a 59M. a femoral stem loosening at 7-months post-op in a 58M. a femoral stem loosening at 16-months post-op in a 64M. an anterior dislocation in a 53M, that was revised 9 days after the primary procedure. CT analysis, prior to revision surgery, revealed acetabular cup orientation of 46°/31° (inclination/anteversion) and femoral stem anteversion of 38°. Conclusions. These preliminary findings suggest the OPS. TM. dynamic planning and delivery system provides good early results, with a low rate of revision for dislocation. Limitations of the study will be discussed


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 31 - 31
1 Dec 2020
Shah DS Taylan O Berger P Labey L Vandenneucker H Scheys L
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Orthopaedic training sessions, vital for surgeons to understand post-operative joint function, are primarily based on passive and subjective joint assessment. However, cadaveric knee simulators, commonly used in orthopaedic research,. 1. could potentially benefit surgical training by providing quantitative joint assessment for active functional motions. The integration of cadaveric simulators in orthopaedic training was explored with recipients of the European Knee Society Arthroplasty Travelling Fellowship visiting our institution in 2018 and 2019. The aim of the study was to introduce the fellows to the knee joint simulator to quantify the surgeon-specific impact of total knee arthroplasty (TKA) on the dynamic joint behaviour, thereby identifying potential correlations between surgical competence and post-operative biomechanical parameters. Eight fellows were assigned a fresh-frozen lower limb each to plan and perform posterior-stabilised TKA using MRI-based patient-specific instrumentation. Surgical competence was adjudged using the Objective Structured Assessment of Technical Skills (OSATS) adapted for TKA. 2. All fellows participated in the in vitro specimen testing on a validated knee simulator,. 3. which included motor tasks – passive flexion (0°-120°) and active squatting (35°-100°) – and varus-valgus laxity tests, in both the native and post-operative conditions. Tibiofemoral kinematics were recorded with an optical motion capture system and compared between native and post-operative conditions using a linear mixed model (p<0.05). The Pearson correlation test was used to assess the relationship between the OSATS scores for each surgeon and post-operative joint kinematics of the corresponding specimen (p<0.05). OSATS scores ranged from 79.6% to 100% (mean=93.1, SD=7.7). A negative correlation was observed between surgical competence and change in post-operative tibial kinematics over the entire range of motion during passive flexion – OSATS score vs. change in tibial abduction (r=−0.87; p=0.003), OSATS score vs. change in tibial rotation (r=−0.76; p=0.02). When compared to the native condition, post-operative tibial internal rotation was higher during passive flexion (p<0.05), but lower during squatting (p<0.033). Post-operative joint stiffness was greater in extension than in flexion, without any correlation with surgical competence. Although trained at different institutions, all fellows followed certain standard intraoperative guidelines during TKA, such as achieving neutral tibial abduction and avoiding internal tibial rotation,. 4. albeit at a static knee flexion angle. However, post-operative joint kinematics for dynamic motions revealed a strong correlation with surgical competence, i.e. kinematic variability over the range of passive flexion post-TKA was lower for more skilful surgeons. Moreover, actively loaded motions exhibited stark differences in post-operative kinematics as compared to those observed in passive motions. In vitro testing on the knee simulator also introduced the fellows to new quantitative parameters for post-operative joint assessment. In conclusion, the inclusion of cadaveric simulators replicating functional joint motions could help quantify training paradigms, thereby enhancing traditional orthopaedic training, as was also the unanimous opinion of all participating fellows in their positive feedback


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11 | Pages 1457 - 1461
1 Nov 2012
Krishnan SP Dawood A Richards R Henckel J Hart AJ

Improvements in the surgical technique of total knee replacement (TKR) are continually being sought. There has recently been interest in three-dimensional (3D) pre-operative planning using magnetic resonance imaging (MRI) and CT. The 3D images are increasingly used for the production of patient-specific models, surgical guides and custom-made implants for TKR. The users of patient-specific instrumentation (PSI) claim that they allow the optimum balance of technology and conventional surgery by reducing the complexity of conventional alignment and sizing tools. In this way the advantages of accuracy and precision claimed by computer navigation techniques are achieved without the disadvantages of additional intra-operative inventory, new skills or surgical time. This review describes the terminology used in this area and debates the advantages and disadvantages of PSI


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_8 | Pages 65 - 65
1 Aug 2020
Ekhtiari S Shah A Levesque J Williams D Yan J Thornley P
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Three-dimensional (3D) printing has become more frequently used in surgical specialties in recent years. Orthopaedic surgery is particularly well-suited to 3D printing applications, and thus has seen a variety of uses for this technology. These uses include pre-operative planning, patient-specific instrumentation (PSI), and patient-specific implant production. As with any new technology, it is important to assess the clinical impact, if any, of three-dimensional printing. The purpose of this review was to answer the following questions: . What are the current clinical uses of 3D printing in orthopaedic surgery?. Does the use of 3D printing have an effect on peri-operative outcomes?. Four electronic databases (Embase, MEDLINE, PubMed, Web of Science) were searched for Articles discussing clinical applications of 3D printing in orthopaedics up to November 13, 2018. Titles, abstracts, and full texts were screened in duplicate and data was abstracted. Descriptive analysis was performed for all studies. A meta-analysis was performed among eligible studies to compare estimated blood loss (EBL), operative time, and fluoroscopy use between 3D printing cases and controls. Study quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) criteria for non-randomized studies and the Cochrane Risk of Bias Tool for randomized controlled trials (RCTs). This review was prospectively registered on PROSPERO (Registration ID: CRD42018099144). One-hundred and eight studies were included, published between 2012 and 2018. A total of 2328 patients were included in these studies, and 1558 patients were treated using 3D printing technology. The mean age of patients, where reported, was 47 years old (range 3 to 90). Three-dimensional printing was most commonly reported in trauma (N = 41) and oncology (N = 22). Pre-operative planning was the most common use of 3D printing (N = 63), followed by final implants (N = 32) and PSI (N = 22). Titanium was the most commonly used 3D printing material (16 studies, 27.1%). A wide range of costs were reported for 3D printing applications, ranging from “less than $10” to $20,000. The mean MINORS score for non-randomized studies was 8.3/16 for non-comparative studies (N = 78), and 17.7/24 for non-randomized comparative studies (N = 19). Among RCTs, the most commonly identified sources of bias were for performance and detection biases. Three-dimensional printing resulted in a statistically significant decrease in mean operative time (−15.6 mins, p < .00001), mean EBL (−35.9 mL, p<.00001), and mean fluoroscopy shots (−3.5 shots, p < .00001) in 3D printing patients compared to controls. The uses of 3D printing in orthopaedic surgery are growing rapidly, with its use being most common in trauma and oncology. Pre-operative planning is the most common use of 3D printing in orthopaedics. The use of 3D printing significantly reduces EBL, operative time, and fluoroscopy use compared to controls. Future research is needed to confirm and clarify the magnitude of these effects


The Bone & Joint Journal
Vol. 98-B, Issue 12 | Pages 1711 - 1712
1 Dec 2016
Haddad FS

L. Spencer-Gardner, J. Pierrepont, M. Topham, J. Baré, S. McMahon, A. J. Shimmin Patient-specific instrumentation improves the accuracy of acetabular component placement in total hip arthroplasty. Bone Joint J 2016;98-B:1342–1346


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 42 - 42
1 Dec 2017
Steimer D Suero E Luecke U Stuebig T Krettek C Liodakis E
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INTRODUCTION. To test whether there are differences in postoperative mechanical and component alignment, and in functional results, between conventional, navigated and patient-specific total knee arthroplasties in a low-volume centre?. MATERIAL AND METHODS. Retrospective cohort study of 391 patients who received conventional, navigated or patient- specific primary cemented TKA in a low-volume hospital. RESULTS. The risk of mechanical alignment outliers was 89% lower in the navigated group compared to the conventional TKA group. There was a 63% lower risk of femoral component malalignment and a 66% lower risk of tibial component malalignment in the navigated group. No significant reduction in the risk of malalignment was seen in the patient-specific group. Total WOMAC and Oxford scores were no different between the three techniques. The patient-specific group reported better WOMAC pain scores. PSI TKA was 33% more expensive than conventional TKA and 28% more expensive than Navigated TKA. DISCUSSION. Navigated TKA improved alignment, but neither navigated nor patient-specific TKA improved functional outcomes. Patient-specific TKA was more expensive, with little additional benefit. Clinical relevance: The routine use of patient-specific instrumentation in low-volume centers is not supported by the currently available data


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_8 | Pages 33 - 33
1 May 2019
Rodriguez J
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Knee replacement is a proven and reproducible procedure to alleviate pain, re-establish alignment and restore function. However, the quality and completeness to which these goals are achieved is variable. The idea of restoring function by reproducing condylar anatomy and asymmetry has been gaining favor. As knee replacements have evolved, surgeons have created a set of principles for reconstruction, such as using the femoral transepicondylar axis (TEA) in order to place the joint line of the symmetric femoral component parallel to the TEA, and this has been shown to improve kinematics. However, this bony landmark is really a single plane surrogate for independent 3-dimensional medial and lateral femoral condylar geometry, and a difference has been shown to exist between the natural flexion-extension arc and the TEA. The TEA works well as a surrogate, but the idea of potentially replicating normal motion by reproducing the actual condylar geometry and its involved, individual asymmetry has great appeal. Great variability in knee anatomy can be found among various populations, sizes, and genders. Each implant company creates their specific condylar geometry, or “so called” J curves, based on a set of averages measured in a given population. These condylar geometries have traditionally been symmetric, with the individualised spatial placement of the (symmetric) curves achieved through femoral component sizing, angulation, and rotation performed at the time of surgery. There is an inherent compromise in trying to achieve accurate, individual medial and lateral condylar geometry reproduction, while also replicating size and avoiding component overhang with a set implant geometry and limited implant sizes. Even with patient-specific instrumentation using standard over-the-counter implants, the surgeon must input his/her desired endpoints for bone resection, femoral rotation, and sizing as guidelines for compromise. When all is done, and soft tissue imbalance exists, soft tissue release is the final, common compromise. The custom, individually made knee design goals include reproducible mechanical alignment, patient-specific fit and positioning, restoration of articular condylar geometry, and thereby, more normal kinematics. A CT scan allows capture of three-dimensional anatomical bony details of the knee. The individual J curves are first noted and corrected for deformity, after which they are anatomically reproduced using a Computer-Aided Design (CAD) file of the bones in order to maximally cover the bony surfaces and concomitantly avoid implant overhang. No options for modifications are offered to the surgeon, as the goal is anatomic restoration. Given these ideals, to what extent are patients improved? The concept of reproducing bony anatomy is based on the pretext that form will dictate function, such that normal-leaning anatomy will tend towards normal-leaning kinematics. Therefore, we seek to evaluate knee function based on objective assessments of movement or kinematics. In summary, the use of custom knee technology to more closely reproduce an individual patient's anatomy holds great promise in improving the quality and reproducibility of postoperative function. Compromises of fit and rotation are minimised, and implant overhang is potentially eliminated as a source of pain. Early results have shown objective improvements in clinical outcomes. Admittedly, this technology is limited to those patients with mild to moderate deformity at this time, since options like constraint and stems are not available. Yet these are the patients who can most clearly benefit from a higher functional state after reconstruction. Time will reveal if this potential can become a reproducible reality


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 119 - 119
1 Apr 2019
Cabarcas B Cvetanovich G Orias AE Inoue N Gowd A Liu J Verma N
Full Access

Background. Accurate placement of the glenoid component in total shoulder arthroplasty (TSA) is critical to optimize implant longevity. Commercially available patient-specific instrumentation systems can improve implant placement, but may involve considerable expense and production delays of up to six weeks. The purpose of this study was to develop a novel technique for in-house production of 3D-printed, patient-specific glenoid guides, and compare the accuracy of glenoid guidepin placement between the patient-specific guide and a standard guide using a cadaveric model. Methods. Twenty cadaveric shoulder specimens were randomized to receive glenoid guidepin placement via standard TSA guide (Wright Medical, Memphis, TN) or patient-specific guide. Three-dimensional scapular models were reconstructed from CT scans with Mimics 20.0 imaging software (Materialise NV, Leuven, Belgium). A pre-surgical plan was created for all specimens for the central glenoid guidepin of 0º version and inclination angles. Central pin entry and exit points were also calculated. Patient-specific guides were constructed to achieve the planned pin trajectory in Rhino3D software (Robert McNeel & Associates, Seattle, WA). Guides were 3D-printed on a Form2 printer with Formlabs Dental SG Resin (Formlabs, Somerville, MA). Glenoid labrum and cartilage were removed with preservation of other soft tissues in all specimens to mimic intraoperative TSA conditions. A fellowship-trained, board-eligible orthopaedic surgeon placed a 2.5 mm diameter titanium guidepin into each glenoid using the assigned guide for each specimen. After pin placement, repeat CT scans were performed, and a blinded measurer used superimposed 3D scapular reconstructions to calculate deviation from the pre-surgical plan in version and inclination angles, dot product angle, and guide pin entry and exit points. Student's t tests were performed to detect differences between pin placements for the two groups. Results. Cadaver age, sex, and BMI did not differ between groups (p>0.05 for all). Average production cost and time for the patient-specific guides were $29.95 and 4 hours and 40 minutes per guide, respectively. Guidepin version deviation did not differ between the patient-specific and standard guides (1.59º ± 1.60º versus 2.88 º ± 2.11º, respectively, p=0.141). Guidepin inclination deviation was significantly lower in the patient-specific group (1.54º ± 1.58º versus 6.42º ± 5.03º, p=0.009), similarly the dot product angle was lower in the patient-specific compared to standard guide group (2.35º ± 1.66º versus 7.48º ± 4.76º, p=0.005). Glenoid entry site exhibited less deviation for the patient-specific compared to standard guide (0.75mm ± 0.54mm versus 2.05mm ± 1.19mm, p=0.006). Glenoid exit site also was closer to the target for the patient- specific compared to standard group (1.75mm ± 0.99mm versus 4.75mm ± 2.97mm, p=0.010). Conclusion. We present a novel technique for in-house production of 3D-printed, patient-specific glenoid guides for TSA glenoid pin placement. These patient-specific guides improved pin placement accuracy based on 3D-CT measurements compared to standard TSA guides in a cadaveric model. Our patient-specific glenoid guides can be produced on-demand, in-house, inexpensively, and with significantly reduced time compared to commercially available guides. Future studies are required to validate these findings in clinical applications and determine the potential impact on implant longevity


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 84 - 84
1 Jun 2018
Rodriguez J
Full Access

Knee replacement is a proven and reproducible procedure to alleviate pain, re-establish alignment and restore function. However, the quality and completeness to which these goals are achieved is variable. The idea of restoring function by reproducing condylar anatomy and asymmetry has been gaining favor. As knee replacements have evolved, surgeons have created a set of principles for reconstruction, such as using the femoral transepicondylar axis (TEA) in order to place the joint line of the symmetric femoral component parallel to the TEA, and this has been shown to improve kinematics. However, this bony landmark is really a single plane surrogate for independent 3-dimensional medial and lateral femoral condylar geometry, and a difference has been shown to exist between the natural flexion-extension arc and the transepicondylar axis. The TEA works well as a surrogate, but the idea of potentially replicating normal motion by reproducing the actual condylar geometry and its involved, individual asymmetry has great appeal. Great variability in knee anatomy can be found among various populations, sizes, and genders. Each implant company creates their specific condylar geometry, or “so called” J curves, based on a set of averages measured in a given population. These condylar geometries have traditionally been symmetric, with the individualised spatial placement of the (symmetric) curves achieved through femoral component sizing, angulation, and rotation performed at the time of surgery. There is an inherent compromise in trying to achieve accurate, individual medial and lateral condylar geometry reproduction, while also replicating size and avoiding component overhang with a set implant geometry and limited implant sizes. Even with patient-specific instrumentation using standard over-the-counter implants, the surgeon must input his/her desired endpoints for bone resection, femoral rotation, and sizing as guidelines for compromise. When all is done, and soft tissue imbalance exists, soft tissue release is the final, common compromise. The custom, individually made knee design goals include reproducible mechanical alignment, patient-specific fit and positioning, restoration of articular condylar geometry, and thereby, more normal kinematics. A CT scan allows capture of three-dimensional anatomical bony details of the knee. The individual J curves are first noted and corrected for deformity, after which they are anatomically reproduced using a Computer-Aided Design (CAD) file of the bones in order to maximally cover the bony surfaces and concomitantly avoid implant overhang. No options for modifications are offered to the surgeon, as the goal is anatomic restoration. In summary, the use of custom knee technology to more closely reproduce an individual patient's anatomy holds great promise in improving the quality and reproducibility of post-operative function. Compromises of fit and rotation are minimised, and implant overhang is potentially eliminated as a source of pain. Early results have shown objective improvements in clinical outcomes. Admittedly, this technology is limited to those patients with mild to moderate deformity at this time, since options like constraint and stems are not available. Yet these are the patients who can most clearly benefit from a higher functional state after reconstruction. Time will reveal if this potential can become a reproducible reality


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_8 | Pages 16 - 16
1 May 2016
Hafez M Sheikhedrees S
Full Access

Background. The knee joint morphology varies according to gender and morphotype of the patients. Objectives. To measure the dimensions of the proximal tibia and distal femur of osteoarthritic knees in a group of patients from the same ethnic group (Arabs) and to compare these measurements with the dimensions of six total knee implants. Patients and methods. Three-dimensional CT reconstructions were used to collect morphologic data from 124 osteoarthritic knees. Anteroposterior and mediolateral measurements were obtained from tibial and femoral bony resection surfaces planned for patient-specific instrumentation (Figures 1 and 2). These measurements were compared to the dimensions for six different types of knee implants. Results. The average tibial mediolateral (tML) and tibial anteroposterior (tAP) measurement for the study group were 74.36±6 mm and 48.94±4.57 mm, respectively; the medial tibial plateau was larger than lateral. The average femur mediolateral (fML) and femur anteroposterior (fAP) measurements for the same group were 72.04±6.6 and 68.1±7.75, respectively. For implant matching, the average tibial aspect ratio was 152.62±12.66 and the femoral average aspect ratio was 106.37±14.34. Differences were found between morphometric measurements of males and females with significantly higher parameters for males when compared to female when compared in AP and mediolateral dimensions. Also, 22.5% of the operated knees had mismatch within 2 size of the same implant. Conclusion. There is significant asymmetry of proximal tibial plateau and femur condyles. Our data suggest mismatch between osteoarthritic Arabian knees and implant designs. These ethnic differences should be considered when designing knee implants


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 27 - 27
1 Jan 2016
Hananouchi T Giets E Ex J Delport H
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Introduction. Optimal alignment of the acetabulum cup component is crucial for good outcome of Total Hip Arthroplasty (THA). A patient-specific instrumentation (PSI) for cup alignment manufactured by 3D printing might improve cup alignment in conventional THAs with patient's lateral decubitus position. In this study, we developed PSI for cup alignment which transferred preoperatively planned cup alignment to the operation room as a linear visual reference(Figure 1), then investigated its accuracy in terms of fitting of PSI on the bony surface and angle deviation between pre- and post-operative cup alignments. Methods. 3-Dimensional bone models created from CT images of both sides of 6 cadaveric specimens were used in the current study. In the first experiment (first 3 specimens and six hips), we designed PSI to fit on the acetabular rim, and we inserted a Kirschner wire (K-wire) through PSI after PSI's fitting. In the second experiment (remaining 3 specimens and six hips), after the same steps like the first experiment were done, we reamed and finally impacted plastic cups with the visual reference of the K-wire. Using postoperative CT images taken after both experiments, we measured deviation of the K-wire placement for the first experiment, and measured deviation of the cup placement from planned cup alignment. Results. The angle deviation of the K-wire alignment on the basis of radiographic inclination and anteversion angles was on average 2.2°±2.5° and 1.0°±1.3° respectively in the first experiment. The angle deviation of the cup alignment with the same definition was on average 2.88°±1.63° and 4.15°±2.56°. For one cadaveric specimen data for the first experiment were missing. Conclusion. We conclude that the accuracy of acetabular cup placement can be improved by the use of patient-specific cup orientation guides


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_15 | Pages 35 - 35
1 Aug 2017
Rodriguez J
Full Access

Knee replacement is a proven and reproducible procedure to alleviate pain, re-establish alignment and restore function. However, the quality and completeness to which these goals are achieved is variable. The idea of restoring function by reproducing condylar anatomy and asymmetry has been gaining favor As knee replacements have evolved, surgeons have created a set of principles for reconstruction, such as using the femoral transepicondylar axis (TEA) in order to place the joint line of the symmetric femoral component parallel to the TEA, and this has been shown to improve kinematics. However, this bony landmark is really a single plane surrogate for 3-dimensional medial and lateral femoral condylar geometry, and a difference has been shown to exist between the natural flexion-extension arc and the TEA. The TEA works well as a surrogate, but the idea of potentially replicating normal motion by reproducing the actual condylar geometry and its involved, individual asymmetry has great appeal. Great variability in knee anatomy can be found among various populations, sizes, and genders. Each implant company creates their specific condylar geometry, or “so called” J curves, based on a set of averages measured in a given population. These condylar geometries have traditionally been symmetric, with the individualised spatial placement of the (symmetric) curves achieved through femoral component sizing, angulation, and rotation performed at the time of surgery. There is an inherent compromise in trying to achieve accurate, individual medial and lateral condylar geometry reproduction, while also replicating size and avoiding component overhang with a set implant geometry and limited implant sizes. Even with patient-specific instrumentation using standard over-the-counter implants, the surgeon must input his/her desired endpoints for bone resection, femoral rotation, and sizing as guidelines for compromise. When all is done, and soft tissue imbalance exists, soft tissue release is the final, common compromise. The custom, individually made knee design goals include reproducible mechanical alignment, patient-specific fit and positioning, restoration of articular condylar geometry, and thereby, more normal kinematics. A CT scan allows capture of three-dimensional anatomical bony details of the knee. The individual J curves are first noted and corrected for deformity, after which they are anatomically reproduced using a Computer-Aided Design (CAD) file of the bones in order to maximally cover the bony surfaces and concomitantly avoid implant overhang. No options for modifications are offered to the surgeon, as the goal is anatomic restoration. Given these ideals, to what extent are patients improved? The concept of reproducing bony anatomy is based on the pretext that form will dictate function, such that normal-leaning anatomy will tend towards normal-leaning kinematics. Therefore, we seek to evaluate knee function based on objective assessments of movement or kinematics. The use of custom knee technology to more closely reproduce an individual patient's anatomy holds great promise in improving the quality and reproducibility of post-operative function. Compromises of fit and rotation are minimised, and implant overhang is potentially eliminated as a source of pain. Early results have shown objective improvements in clinical outcomes. Admittedly, this technology is limited to those patients with mild to moderate deformity at this time, since options like constraint and stems are not available. Yet these are the patients who can most clearly benefit from a higher functional state after reconstruction. Time will reveal if this potential can become a reproducible reality


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 559 - 559
1 Dec 2013
Thienpont E
Full Access

Background. Finding the anatomical landmarks used for correct femoral rotational alignment can be difficult. The Posterior Condylar Line (PCL) is probably the easiest to find during surgery. The aim of this study was to analyze if a predetermined fixed angle referencing of the PCL could help obtain good femoral alignment in TKA patients. Methods. 2637 CT scans used for preoperative planning and creation of patient-specific instrumentation (PSI) were used to analyze the Posterior Condylar Angle (PCA) between the Surgical Epicondylar Axis (SEA) and the PCL. Results. The mean PCA was 3.99° +/− 1.35° of external rotation. A significant relation was found between more external rotation and more varus of the tibia and more valgus of the femur. In 132 patients bilateral CT's were available and 94 (71%) had rotation within 1° of the opposite side. 96% of patients would receive the right amount of external rotation with 6°. On 105 (4%) CT's external rotation between 7° to 11° was measured and 77 (73%) of those were in varus or neutral alignment. Conclusions. After substracting a correction of 1° for cartilage remnants, a posterior condylar angle of 5° external rotation is proposed which should cover 96% of the population. For 4% of patients, both varus and valgus knees, 5° of external rotation will not be sufficient. The epicondylar axis should be explored during surgery, determined with patient-specific instruments, or a balancer should be used for this group


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 64 - 64
1 May 2014
Rosenberg A
Full Access

The presentations to be discussed by the panel are: 1.) No Increased Risk of Knee Arthroplasty Failure in Metal Hypersensitive Patients: A Matched Cohort Study; 2.) Knee Arthrodesis is Most Likely to Control Infection and Preserve Function Following Failed 2 Stage Procedure for Treatment of Infected TKA: A Decision Tree Analysis; 3.) Does Malnutrition Correlate with Septic Failure of Hip and Knee Arthroplasties?; 4.) Diagnosing Periprosthetic Joint Infection: The Era of the Biomarker Has Arrived; 5.) Are Patient Reported Allergies a Risk Factor for Poor Outcomes in Total Hip and Knee Arthroplasty?; 6.) Revising an HTO or UKA to TKA: Is it more like a Primary TKA or a Revision TKA?; 7.) At 5 Years Highly-Porous-Metal Tibial Components Were Durable and Reliable: A Randomised Clinical Trial of 389 Patients; 8.) Current Data Does Not Support Routine Use of Patient-Specific Instrumentation in Total Knee Arthroplasty; 9.) Barbed vs. Standard Sutures for Closure in Total Knee Arthroplasty: A Multicenter Prospective Randomised Trial; 10.) Particles from Vitamin-E-diffused HXL UHMWPE Induce Less Osteolysis Compared to Virgin HXL UHMWPE in a Murine Calvarial Bone Model; 11.) Construct Rigidity: Keystone for Reconstructing Pelvic Discontinuity; 12.) Do You Have to Remove a Corroded Femoral Stem?; 13.) Direct Anterior Versus Mini-Posterior Total Hip Arthroplasty with the Same Advanced Pain Management and Rapid Rehabilitation Protocol: Some Surprises in Early Outcome; 14.) Adverse Clinical Outcomes in a Primary Modular Neck/Stem System


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 77 - 77
1 Apr 2017
Rodriguez J
Full Access

Knee replacement is a proven and reproducible procedure to alleviate pain, re-establish alignment and restore function. However, the quality and completeness to which these goals are achieved is variable. The idea of restoring function by reproducing condylar anatomy and asymmetry has been gaining favor. As knee replacements have evolved, surgeons have created a set of principles for reconstruction, such as using the femoral transepicondylar axis (TEA) in order to place the joint line of the symmetric femoral component parallel to the TEA, and this has been shown to improve kinematics. However, this bony landmark is really a single plane surrogate for 3-dimensional medial and lateral femoral condylar geometry, and a difference has been shown to exist between the natural flexion-extension arc and the TEA. The TEA works well as a surrogate, but the idea of potentially replicating normal motion by reproducing the actual condylar geometry and its involved, individual asymmetry has great appeal. Great variability in knee anatomy can be found among various populations, sizes, and genders. Each implant company creates their specific condylar geometry, or “so called” J curves, based on a set of averages measured in a given population. These condylar geometries have traditionally been symmetric, with the individualised spatial placement of the (symmetric) curves achieved through femoral component sizing, angulation, and rotation performed at the time of surgery. There is an inherent compromise in trying to achieve accurate, individual medial and lateral condylar geometry reproduction, while also replicating size and avoiding component overhang with a set implant geometry and limited implant sizes. Even with patient-specific instrumentation using standard over-the-counter implants, the surgeon must input his/her desired endpoints for bone resection, femoral rotation, and sizing as guidelines for compromise. When all is done, and soft tissue imbalance exists, soft tissue release is the final, common compromise. The custom, individually made knee design goals include reproducible mechanical alignment, patient-specific fit and positioning, restoration of articular condylar geometry, and thereby, more normal kinematics. A CT scan allows capture of three-dimensional anatomical bony details of the knee. The individual J curves are first noted and corrected for deformity, after which they are anatomically reproduced using a Computer-Aided Design (CAD) file of the bones in order to maximally cover the bony surfaces and concomitantly avoid implant overhang. No options for modifications are offered to the surgeon, as the goal is anatomic restoration. Given these ideals, to what extent are patients improved? The concept of reproducing bony anatomy is based on the pretext that form will dictate function, such that normal-leaning anatomy will tend towards normal-leaning kinematics. Therefore, we seek to evaluate knee function based on objective assessments of movement or kinematics. In summary, the use of custom knee technology to more closely reproduce an individual patient's anatomy holds great promise in improving the quality and reproducibility of post-operative function. Compromises of fit and rotation are minimised, and implant overhang is potentially eliminated as a source of pain. Early results have shown objective improvements in clinical outcomes. Admittedly, this technology is limited to those patients with mild to moderate deformity at this time, since options like constraint and stems are not available. Yet these are the patients who can most clearly benefit from a higher functional state after reconstruction. Time will reveal if this potential can become a reproducible reality


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_7 | Pages 10 - 10
1 Apr 2014
Halai M Jamal B Robinson P Qureshi M Kimpton J Syme B McMillan J Holt G
Full Access

Three distal femoral axes have been described to aid in alignment of the femoral component; the Trans Epicondylar Axis (TEA), the Posterior Condylar Axis (PCA) and the Antero Posterior (AP) axis. Our aim was to identify if there was a reproducible relationship between the axes. Hopefully this will aid the surgeon to more accurately judge the rotation of the femoral cutting block by using the axes with the least variation. This is the first study compare all three distal femoral axes with each other using magnetic resonance imaging (MRI) in a Caucasian population awaiting total knee arthroplasty (TKA). We identified the relationship between these axes by performing MRI scans on 89 patients awaiting TKA with patient-specific instrumentation. Measurements were taken by two observers. Patients had a mean age of 62.5 years (range 32–91). 51 patients were female. The mean angle between the TEA and AP axis was 92.78°, standard deviation (SD) 2.51° (range 88°–99°). The mean angle between the AP axis and PCA was 95.43°, SD 2.75° (range 85°–105°). The mean angle between the TEA and PCA was 2.78°, SD 1.91° (range 0°–10°). We conclude that while there is a reproducible relationship between the differing femoral axes, there is a significant range in the relationship between the femoral axes. This range may lead to greater inaccuracy than has previously been appreciated when defining the rotation of the femoral component. There is most variation between the PCA and the AP axis. Most systems have a cutting block with 3° of external rotation from the PCA and this would be parallel to the TEA in the majority, but not all, cases in this series. This data suggests that if the surgeon is to pick two axes to reference from, one should include the TEA


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 56 - 56
1 Jan 2017
Belvedere C Ensini A Tamarri S Ortolani M Leardini A
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In total knee replacement (TKR), neutral mechanical alignment (NMA) is targeted in prosthetic component implantation. A novel implantation approach, referred to as kinematic alignment (KA), has been recently proposed (Eckhoff et al. 2005). This is based on the pre-arthritic lower limb alignment which is reconstructed using suitable image-based techniques, and is claimed to allow better soft-tissue balance (Eckhoff et al. 2005) and restoration of physiological joint function. Patient-specific instrumentation (PSI) introduced in TKR to execute personalized prosthesis component implantation are used for KA. The aim of this study was to report knee kinematics and electromyography (EMG) for a number lower limb muscles from two TKR patient groups, i.e. operated according to NMA via conventional instrumentation, or according to KA via PSI. 20 patients affected by primary gonarthrosis were implanted with a cruciate-retaining fixed-bearing prosthesis with patella resurfacing (Triathlon® by Stryker®, Kalamazoo, MI-USA). 17 of these patients, i.e. 11 operated targeting NMA (group A) via convention instrumentation and 6 targeting KA (group B) via PSI (ShapeMatch® by Stryker®, Kalamazoo, MI-USA), were assessed clinically using the International Knee Society Scoring (IKSS) System and biomechanically at 6-month follow-up. Knee kinematics during stair-climbing, chair-rising and extension-against-gravity was analysed by means of 3D video-fluoroscopy (CAT® Medical System, Monterotondo, Italy) synchronized with 4-channel EMG analysis (EMG Mate, Cometa®, Milan, Italy) of the main knee ad/abductor and flexor/extensor muscles. Knee joint motion was calculated in terms of flex/extension (FE), ad/abduction (AA), and internal/external rotation (IE), together with axial rotation of condyle contact point line (CLR). Postoperative knee and functional IKSS scores in group A were 78±20 and 80±23, worse than in group B, respectively 91±12 and 90±15. Knee motion patterns were much more consistent over patients in group B than A. In both groups, normal ranges were found for FE, IE and AA, the latter being generally smaller than 3°. Average IE ranges in the three motor tasks were respectively 8.2°±3.2°, 10.1°±3.9° and 7.9°±4.0° in group A, and 6.6°±4.0°, 10.5°±2.5° and 11.0°±3.9° in group B. Relevant CLRs were 8.2°±3.2°, 10.2°±3.7° and 8.8°±5.3° in group A, and 7.3°±3.5°, 12.6°±2.6° and 12.5°±4.2° in group B. EMG analysis revealed prolonged activation of the medial/lateral vasti muscles in group A. Such muscle co-contraction was not generally observed in all patients in group B, this perhaps proving more stability in the knee replaced following the KA approach. These results reveal that KA results in better function than NMA in TKR. Though small differences were observed between groups, the higher data consistency and the less prolonged muscle activations detected using KA support indirectly the claim of a more natural knee soft tissue balance. References


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_20 | Pages 91 - 91
1 Nov 2016
Almaawi A Alsheikh K Masse V Lavigne M Vendittoli P
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Modifying Knee anatomy during mechanical Total Knee Arthroplasty (TKA) may impact ligament balance, patellar tracking and quadriceps function. Although well fixed, patients may report high levels (20%) of dissatisfaction. One theory is that putting the knee in neutral mechanical alignment may be responsible for these unsatisfactory results. Kinematic TKA has gained interest in recent years; it aims to resurface the knee joint and preservation of natural femoral flexion axis about which the tibia and patella articulate, recreating the native knee without the need for soft tissue relaease. That's being said, it remains the question of whether all patients are suitable for kinematic alignment. Some patients' anatomy may be inherently biomechanically inferior and recreating native anatomy in these patients may result in early implant failure. The senior author (PAV) has been performing Kinematic TKA since 2011, and has developed an algorithm in order to better predict which patient may benefit from this technique. Lower limb CT scans from 4884 consecutive patients scheduled for TKA arthroplasty were analysed. These exams were performed for patient-specific instrumentation production (My Knee®, Medacta, Switzerland). Multiple anatomical landmarks used to create accurate CT-based preoperative planning and determine the mechanical axis of bone for the femur and tibia and overall Hip-knee-Ankle (HKA). We wanted to test the safe range for kinematic TKA for the planned distal resection of the femur and tibia. Safe range algorithm was defined as the combination of the following criteria: – Independent tibial and femoral cuts within ± 5° of the bone neutral mechanical axis and HKA within ± 3°. The purpose of this study is to verify the applicability of the proposed safe range algorithm on a large sample of individual scheduled for TKA. The preoperative tibial mechanical angle average 2.9 degrees in varus, femoral mechanical angle averaged 2.7 degrees in valgus and overall HKA averaged of 0.1 in varus. There were 2475 (51%) knees out of 4884, with femur and tibia mechanical axis within ±5° and HKA within ±3° without need for bony corrections. After applying the algorithm, a total of 4062 cases (83%) were successfully been evaluated using the proposed protocol to reach a safe range of HKA ±3° with minimal correction. The remaining 822 cases (17%) could not be managed by the proposed algorithm because of their unusual anatomies and were dealt with individually. In this study, we tested a proposed algorithm to perform kinematic alignment TKA avoiding preservation/restoration of some extreme anatomies that might not be suitable for TKA long-term survivorship. A total of 4062 cases (83%) were successfully eligible for our proposed safe range algorithm for kinematic TKA. In conclusion, kinematically aligned TKA may be a promising option to improve normal knee function restoration and patient satisfaction. Until we have valuable data confirming the compatibility of all patients' pre arthritic anatomies with TKA long-term survivorship, we believe that kinematically alignment should be performed within some limits. Further studies with Radiostereometry or longer follow up might help determine if all patients' anatomies are suitable for Kinematic TKA


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XLIV | Pages 40 - 40
1 Oct 2012
McCoy B Yaffe M Stulberg S
Full Access

Custom instrumentation in TKA utilises pre-operative imaging to generate a customised guide for cutting block placement. The surgeon is able to modify the plan using three-dimensional software. Although this technology is increasingly gaining acceptance, there is a paucity of clinical data supporting it. One hundred and eleven patients underwent primary TKA using the Zimmer Patient-Specific Instrumentation (PSI) system, in 28 of the cases surgical navigation was used to validate the PSI-generated cuts. Alignment measurements included long-leg alignment and biplanar distal femoral and proximal tibial cuts. Further measurements evaluated femoral implant placement in the AP plane, femoral component rotation, measured bone resection and implant sizing accuracy. The mean final limb alignment as recorded by computer-assisted surgical (CAS) tools was 0.3° of varus. Only two limbs were malaligned by greater than 3°. The femoral component had a mean alignment of 0.3° of valgus and 4.5° of flexion (PSI plan 3° flexion). The predicted femoral size was accurate in 89% of cases and the anterior femoral cut was congruent with the anterior cortex in 92% of cases. The PSI-directed femoral component rotation was consistent with the surgeon's perceived rotation in 95% of cases. The posterior condylar bone resection had a mean difference of < 1mm from the predicted resection. The tibial component had a mean alignment of 0.5° of varus and 8.5° of posterior slope (PSI plan 7° posterior slope). The only statistically significant deviation in alignment was the increased tibial slope (p = 0.046). The tibial component size was accurately predicted in 66% of cases. Custom instrumentation in total knee arthroplasty accurately achieved implant and limb alignment in our study. The plan was more reproducible on the femoral slide. The overestimation of tibial slope and tibial sizing incongruity were related to some of the reference points for the software. A potential benefit of this technology is improved mid-flexion stability by accurately determining femoral component size, placement, and rotation. Further studies will need to be conducted to determine the efficiency and cost-effectiveness of this technology


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XL | Pages 222 - 222
1 Sep 2012
McCoy B Yaffe M Stulberg SD
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Introduction. Custom instrumentation in TKA utilizes pre-operative imaging to generate a customized guide for cutting block placement (Figure 1). The surgeon is able to modify the plan using three-dimensional software (Figure 2). Although this technology is increasingly gaining acceptance, there is a paucity of clinical data supporting it. Methods. One hundred and eleven patients underwent primary TKA using the Patient-Specific Instrumentation (PSI) system, in twenty-eight of the cases surgical navigation was used to validate the PSI-generated cuts. Alignment measurements included long-leg alignment and biplanar distal femoral and proximal tibial cuts. Further measurements evaluated femoral implant placement in the AP plane, femoral component rotation, measured bone resection and implant sizing accuracy. Results. The mean final limb alignment as recorded by computer-assisted surgical (CAS) tools was 0.3° of varus. Only two limbs were malaligned by greater than 3° (Figure 3). The femoral component had a mean alignment of 0.3° of valgus and 4.5° of flexion (PSI plan 3° flexion). The predicted femoral size was accurate in 89% of cases and the anterior femoral cut was congruent with the anterior cortex in 92% of cases. The PSI-directed femoral component rotation was consistent with the surgeon's perceived rotation in 95% of cases. The posterior condylar bone resection had a mean difference of < 1mm from the predicted resection. The tibial component had a mean alignment of 0.5° of varus and 8.5° of posterior slope (PSI plan 7° posterior slope). The only statistically significant deviation in alignment was the increased tibial slope (p=0.046) (Figure4). The tibial component size was accurately predicted in 66% of cases. Discussion. Custom instrumentation in total knee arthroplasty accurately achieved implant and limb alignment in our study. The plan was more reproducible on the femoral slide. The overestimation of tibial slope and tibial sizing incongruity were related to some of the reference points for the software. A potential benefit of this technology is improved mid-flexion stability by accurately determining femoral component size, placement, and rotation. Further studies are needed to determine the efficiency and cost-effectiveness of this technology


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 539 - 539
1 Dec 2013
Alvi H Luo M Talati R Sweeney P Patel A Yaffe M Stulberg SD
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Introduction:. Total knee arthroplasty (TKA) is an effective operation for the management of osteoarthritis of the knee. Conventional technique utilizing manual instrumentation (MI) allows for reproducible and accurate execution of the procedure. The most common techniques make use of intramedullary femoral guides and either extrameduallary or intrameduallary tibial guides. While these methods can achieve excellent results in the majority of patients, those with ipsilateral hardware, post-traumatic deformity or abnormal anatomy may preclude the accurate use of these techniques. Patient-specific instrumentation (PSI) is an alternative innovation for total knee arthroplasty. Utilizing magnetic resonance imaging (MRI) or computed tomography (CT), custom guide blocks are fabricated based on a patient's unique anatomy. This allows for the benefits of computer assisted navigation (CAN) but without the increased operative times or the high learning curve associated with it. Furthermore it allows the use of familiar cutting blocks and guides to check the accuracy of the PSI guide blocks. In this study we sought to evaluate the accuracy of PSI techniques in patients with previous ipsilateral hardware, which would make the use of MI technically challenging and possibly subject to inaccuracy. Methods:. After reviewing our database of 300 PSI total knee arthroplasty patients, 16 patients were identified (10 male, 6 female) using the Zimmer NexGen Patient Specific Instrumentation System. Fourteen patients included in the study had a preexisting total hip arthroplasty on the ipsilateral side, 1 had a preexisting sliding hip screw, and 1 patient had a preexisting cephalomedullary nail. Postoperative mechanical axis alignment measurements were performed using plain long-standing radiographs. The American Knee Society Score was used to evaluate clinical outcomes postoperatively. Results:. Sixteen total knee arthroplasties were performed using PSI, all in the setting of previous ipsilateral hardware placement. The average age at the time of surgery was 72, with patients ranging from 56 to 85 years of age. Eleven of the included knees had a preoperative varus alignment and 5 had valgus alignment. The average value of a deformity identified via the preoperative planning software was 7.85°. The average value of a deformity identified via preoperative radiographs was 10.1°. Average postoperative mechanical axis was 3.1° measured from plain radiographs. Average angle between the femoral mechanical axis and femoral component was 90.0°. The average angle between the tibial mechanical axis and tibial component was 90.6°. The average difference between the femoral mechanical and anatomic axes was 5.9°. The average discrepancy between medial and lateral joint space on an anterior-posterior standing radiograph was 0.4 mm. At an average of 4.5 months follow-up, American Knee Society knee scores show an aggregate average score of 82.94. Conclusion:. Patient specific instrumentation is an innovative technology in TKA that replaces the use of intramedullary femoral guides and either extramedullary or intramedullary tibial guides. This study demonstrates that PSI is capable of producing favorable radiographic and clinical outcomes despite preexisting ipsilateral hardware, which may preclude the use of customary manual instrumentation. We believe PSI is an accurate and effective tool for use in patients with preexisting ipsilateral hardware


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_28 | Pages 95 - 95
1 Aug 2013
Ensini A Leardini A d'Amato M Fusai F Belvedere C Barbadoro P Timoncini A Giannini S
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INTRODUCTION. In Total Knee Arthroplasty (TKA), the neutral overall limb alignment (NOLA), i.e. the mechanical alignment of the lower limb within 0°±3°, is targeted for achieving good clinical/functional results. The kinematic overall limb alignment (KOLA), which uses the axis through the centres of the femur posterior condyles modelled as cylinders, represents a novel approach for achieving better soft tissue balance. Patient-specific instrumentation (PSI) is nowadays offered as an effective technology in TKA to obtain better lower limb alignments than those via conventional guides (CON). Although relevant results are still inconsistent, the benefits claimed include shorter operative time, reduced surgical instrumentation, and accurate preoperative planning. The aim of this study was to report the preliminary clinical and radiological results of TKA patients operated via NOLA-PSI and KOLA-PSI. Comparisons between them and with the results obtained via NOLA-CON were performed. PATIENTS AND METHODS. A four-centre randomised study on 144 patients has been designed to assess these three techniques. In each centre, 36 patients are planned to be operated, 12 per technique. Currently, in our centre 18 patients have been operated so far: 6 via NOLA-CON (Group A), 3 via NOLA-PSI (Group B), and 9 via KOLA-PSI (Group C). All patients were implanted with a cruciate-retaining TKA (Triathlon®, Stryker®-Orthopaedics, Mahwah, NJ-USA) with patella resurfacing, those in PSI groups according to Otismed® imaging protocol. This includes pre-operative MRI scans at the hip, knee and ankle joints. Clinical evaluations were performed pre-operatively, at 45 days, and 3, 6 and 12 months post-operatively using the knee and functional IKSS (International Knee Society Score). At 45 days post-operatively a weight-bearing long leg radiograph was performed to measure possible differences between planned and implanted component alignment in patients operated via NOLA groups (A and B) and via KOLA group (C). RESULTS. The post-operative knee and functional scores at the most recent follow-up in NOLA groups (A and B) were 78±19 (minimum÷maximum, 51÷95) and 80±23 (45÷100), respectively; in group C these were 91±12 (65÷100) and 89±15 (60÷100). The mean alignment of the mechanical axis in the coronal plane in NOLA-CON (group A) was 1.5° in varus, the 20% being larger than 3° and considered as outliers. In the PSI groups (B and C), the mean absolute difference with respect to the planned alignment was 0.7°, without outliers. Only one complication was observed (group B), where a manipulation was necessary two months after TKA due to small knee motion range. DISCUSSION. The present results in PSI showed good accuracy and reproducibility of the planned alignments with respect to those achieved during surgery. Particularly, KOLA showed better clinical/functional results, without soft tissue release; the 25% of the remaining patients had medial or lateral structure release. KOLA seems the ideal reference in TKA, though it does not reflect normal morphology. However, lower limb alignment larger than 3° has been estimated in an important fraction of the normal adult population. In conclusion these preliminary results revealed a good efficacy of the examined PSI, in general, and better clinical results via KOLA


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_15 | Pages 126 - 126
1 Mar 2013
Snyder B Ayers D Franklin P
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Purpose. Arthritis is the most common chronic illness in the United States. TKR provides reliable pain relief and improved function for patients with advanced knee arthritis. Total joint replacement now represents the greatest expense in the national healthcare budget. Surgical costs are driven by two key components: fixed and variable costs. Patient Specific Instruments™ (PSI, Zimmer, Warsaw, IN, USA) has the potential to reduce both fixed and variable costs by shortening operative time and reducing surgical instrumentation. However, PSI requires the added costs of pre-operative MRI scanning and fabrication of custom pin guides. Previous studies have shown reduction in operating room times and required instrumentation, but question the cost-effectiveness of the technology. Also, these studies failed to show improvement in coronal alignment, but call for additional studies to determine any improvement in clinical function and patient satisfaction. Our pilot study aims to compare the incremental PSI costs to fixed and variable OR cost savings, and compare meaningful patient and clinical outcomes between PSI and standard TKR surgeries. Methods. This IRB approved, prospective, randomized pilot trial involves 20 TKR patients. Inclusion criteria includes: diagnosis of osteoarthritis, ability to undergo MRI, and consent for primary TKR. Following informed consent, patients are randomized to PSI or standard TKR. Patients randomized to PSI undergo pre-operative non-contrast MRI of the affected knee at least 4 weeks prior to surgery. Custom pin guides are prototyped from 3D pre-operative planning software customizable to individual surgeon and patient. All surgeries will be completed by a single surgeon (DA), using a medial parapatellar arthrotomy and Zimmer Nexgen™ implants. Surgical technique for PSI patients utilizes custom pin guides to determine placement of the femoral and tibial cutting guides, whereas an intramedullary femoral rod and extramedullary tibial guide are used in standard TKR patients. Our pilot study will compare numerous intra-operative and post-operative variables between the two patient cohorts. Intra-operative variables include: bony cutting time, tourniquet time, total OR time, surgical instrumentation, and bony resection height. Post-operative variables include: instrument processing and sterilization, blood transfusion, pain medication usage, length of stay, complications (including hospital readmission), and patient reported outcomes (SF-36, WOMAC, and satisfaction) at 4 weeks, 6 months, and 1 year. Additional economic sensitivity analyses using hospital and national cost-to-charge figures will quantify the potential added revenue or costs of implementing the PSI system. Discussion. This pilot study will illustrate the potential benefits of the PSI technology. To our knowledge no clinical trials have been published on the PSI system. Former studies have neglected to include meaningful clinical and patient outcomes, which could potentially add to the cost savings of the technology through reduced blood transfusions, length of stay, and hospital readmission. Additionally, improved rotational alignment may produce superior patient function and satisfaction. Studies recently published on alternative patient-specific TKR systems question the cost-effectiveness and technical improvement of patient-specific instrumentation. Although our sample size may fail to produce statistical significance, the consummate measurement of all the proposed hospital, surgical, and patient factors will inform future randomized multicenter trials


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 114 - 120
1 Feb 2024
Khatri C Metcalfe A Wall P Underwood M Haddad FS Davis ET

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.

Cite this article: Bone Joint J 2024;106-B(2):114–120.


Bone & Joint Open
Vol. 4, Issue 9 | Pages 682 - 688
6 Sep 2023
Hampton M Balachandar V Charalambous CP Sutton PM

Aims

Aseptic loosening is the most common cause of failure following cemented total knee arthroplasty (TKA), and has been linked to poor cementation technique. We aimed to develop a consensus on the optimal technique for component cementation in TKA.

Methods

A UK-based, three-round, online modified Delphi Expert Consensus Study was completed focusing on cementation technique in TKA. Experts were identified as having a minimum of five years’ consultant experience in the NHS and fulfilling any one of the following criteria: a ‘high volume’ knee arthroplasty practice (> 150 TKAs per annum) as identified from the National joint Registry of England, Wales, Northern Ireland and the Isle of Man; a senior author of at least five peer reviewed articles related to TKA in the previous five years; a surgeon who is named trainer for a post-certificate of comletion of training fellowship in TKA.


Bone & Joint 360
Vol. 11, Issue 5 | Pages 20 - 23
1 Oct 2022


Bone & Joint Open
Vol. 4, Issue 4 | Pages 262 - 272
11 Apr 2023
Batailler C Naaim A Daxhelet J Lustig S Ollivier M Parratte S

Aims

The impact of a diaphyseal femoral deformity on knee alignment varies according to its severity and localization. The aims of this study were to determine a method of assessing the impact of diaphyseal femoral deformities on knee alignment for the varus knee, and to evaluate the reliability and the reproducibility of this method in a large cohort of osteoarthritic patients.

Methods

All patients who underwent a knee arthroplasty from 2019 to 2021 were included. Exclusion criteria were genu valgus, flexion contracture (> 5°), previous femoral osteotomy or fracture, total hip arthroplasty, and femoral rotational disorder. A total of 205 patients met the inclusion criteria. The mean age was 62.2 years (SD 8.4). The mean BMI was 33.1 kg/m2 (SD 5.5). The radiological measurements were performed twice by two independent reviewers, and included hip knee ankle (HKA) angle, mechanical medial distal femoral angle (mMDFA), anatomical medial distal femoral angle (aMDFA), femoral neck shaft angle (NSA), femoral bowing angle (FBow), the distance between the knee centre and the top of the FBow (DK), and the angle representing the FBow impact on the knee (C’KS angle).


Bone & Joint Research
Vol. 11, Issue 4 | Pages 210 - 213
1 Apr 2022
Fontalis A Haddad FS


Bone & Joint Open
Vol. 3, Issue 5 | Pages 383 - 389
1 May 2022
Motesharei A Batailler C De Massari D Vincent G Chen AF Lustig S

Aims

No predictive model has been published to forecast operating time for total knee arthroplasty (TKA). The aims of this study were to design and validate a predictive model to estimate operating time for robotic-assisted TKA based on demographic data, and evaluate the added predictive power of CT scan-based predictors and their impact on the accuracy of the predictive model.

Methods

A retrospective study was conducted on 1,061 TKAs performed from January 2016 to December 2019 with an image-based robotic-assisted system. Demographic data included age, sex, height, and weight. The femoral and tibial mechanical axis and the osteophyte volume were calculated from CT scans. These inputs were used to develop a predictive model aimed to predict operating time based on demographic data only, and demographic and 3D patient anatomy data.


The Bone & Joint Journal
Vol. 104-B, Issue 5 | Pages 604 - 612
1 May 2022
MacDessi SJ Wood JA Diwan A Harris IA

Aims

Intraoperative pressure sensors allow surgeons to quantify soft-tissue balance during total knee arthroplasty (TKA). The aim of this study was to determine whether using sensors to achieve soft-tissue balance was more effective than manual balancing in improving outcomes in TKA.

Methods

A multicentre randomized trial compared the outcomes of sensor balancing (SB) with manual balancing (MB) in 250 patients (285 TKAs). The primary outcome measure was the mean difference in the four Knee injury and Osteoarthritis Outcome Score subscales (ΔKOOS4) in the two groups, comparing the preoperative and two-year scores. Secondary outcomes included intraoperative balance data, additional patient-reported outcome measures (PROMs), and functional measures.


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 912 - 919
1 Aug 2023
Cunningham LJ Walton M Bale S Trail IA

Aims

Reverse total shoulder arthroplasty (rTSA) can be used in complex cases when the glenoid requires reconstruction. In this study, a baseplate with composite bone autograft and a central trabecular titanium peg was implanted, and its migration was assessed for two years postoperatively using radiostereometric analysis (RSA).

Methods

A total of 14 patients who underwent a rTSA with an autograft consented to participate. Of these, 11 had a primary rTSA using humeral head autograft and three had a revision rTSA with autograft harvested from the iliac crest. The mean age of the patients was 66 years (39 to 81). Tantalum beads were implanted in the scapula around the glenoid. RSA imaging (stereographic radiographs) was undertaken immediately postoperatively and at three, six, 12, and 24 months. Analysis was completed using model-based RSA software. Outcomes were collected preoperatively and at two years postoperatively, including the Oxford Shoulder Score, the American Shoulder and Elbow Score, and a visual analogue score for pain. A Constant score was also obtained for the assessment of strength and range of motion.


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 3 - 5
1 Jan 2022
Rajasekaran RB Ashford R Stevenson JD Pollock R Rankin KS Patton JT Gupta S Cosker TDA


Bone & Joint 360
Vol. 10, Issue 3 | Pages 20 - 23
1 Jun 2021


The Bone & Joint Journal
Vol. 103-B, Issue 11 | Pages 1642 - 1645
1 Nov 2021
Kayani B Giebaly D Haddad FS


Aims

Nearly 99,000 total knee arthroplasties (TKAs) are performed in UK annually. Despite plenty of research, the satisfaction rate of this surgery is around 80%. One of the important intraoperative factors affecting the outcome is alignment. The relationship between joint obliquity and functional outcomes is not well understood. Therefore, a study is required to investigate and compare the effects of two types of alignment (mechanical and kinematic) on functional outcomes and range of motion.

Methods

The aim of the study is to compare navigated kinematically aligned TKAs (KA TKAs) with navigated mechanically aligned TKA (MA TKA) in terms of function and ROM. We aim to recruit a total of 96 patients in the trial. The patients will be recruited from clinics of various consultants working in the trust after screening them for eligibility criteria and obtaining their informed consent to participate in this study. Randomization will be done prior to surgery by a software. The primary outcome measure will be the Knee injury and Osteoarthritis Outcome Score The secondary outcome measures include Oxford Knee Score, ROM, EuroQol five-dimension questionnaire, EuroQol visual analogue scale, 12-Item Short-Form Health Survey (SF-12), and Forgotten Joint Score. The scores will be calculated preoperatively and then at six weeks, six months, and one year after surgery. The scores will undergo a statistical analysis.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1277 - 1278
1 Oct 2020
Hughes R Hallstrom B Schemanske C Howard PW Wilton T


Bone & Joint Open
Vol. 2, Issue 7 | Pages 503 - 508
8 Jul 2021
Callaghan CJ McKinley JC

Aims

Arthroplasty has become increasingly popular to treat end-stage ankle arthritis. Iatrogenic posterior neurovascular and tendinous injury have been described from saw cuts. However, it is hypothesized that posterior ankle structures could be damaged by inserting tibial guide pins too deeply and be a potential cause of residual hindfoot pain.

Methods

The preparation steps for ankle arthroplasty were performed using the Infinity total ankle system in five right-sided cadaveric ankles. All tibial guide pins were intentionally inserted past the posterior tibial cortex for assessment. All posterior ankles were subsequently dissected, with the primary endpoint being the presence of direct contact between the structure and pin.


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1150 - 1154
1 Jun 2021
Kurisunkal V Laitinen MK Kaneuchi Y Kapanci B Stevenson J Parry MC Reito A Fujiwara T Jeys LM

Aims

Controversy exists as to what should be considered a safe resection margin to minimize local recurrence in high-grade pelvic chondrosarcomas (CS). The aim of this study is to quantify what is a safe margin of resection for high-grade CS of the pelvis.

Methods

We retrospectively identified 105 non-metastatic patients with high-grade pelvic CS of bone who underwent surgery (limb salvage/amputations) between 2000 and 2018. There were 82 (78%) male and 23 (22%) female patients with a mean age of 55 years (26 to 84). The majority of the patients underwent limb salvage surgery (n = 82; 78%) compared to 23 (22%) who had amputation. In total, 66 (64%) patients were grade 2 CS compared to 38 (36%) grade 3 CS. All patients were assessed for stage, pelvic anatomical classification, type of resection and reconstruction, margin status, local recurrence, distant recurrence, and overall survival. Surgical margins were stratified into millimetres: < 1 mm; > 1 mm but < 2 mm; and > 2 mm.


Bone & Joint Open
Vol. 2, Issue 6 | Pages 397 - 404
1 Jun 2021
Begum FA Kayani B Magan AA Chang JS Haddad FS

Limb alignment in total knee arthroplasty (TKA) influences periarticular soft-tissue tension, biomechanics through knee flexion, and implant survival. Despite this, there is no uniform consensus on the optimal alignment technique for TKA. Neutral mechanical alignment facilitates knee flexion and symmetrical component wear but forces the limb into an unnatural position that alters native knee kinematics through the arc of knee flexion. Kinematic alignment aims to restore native limb alignment, but the safe ranges with this technique remain uncertain and the effects of this alignment technique on component survivorship remain unknown. Anatomical alignment aims to restore predisease limb alignment and knee geometry, but existing studies using this technique are based on cadaveric specimens or clinical trials with limited follow-up times. Functional alignment aims to restore the native plane and obliquity of the joint by manipulating implant positioning while limiting soft tissue releases, but the results of high-quality studies with long-term outcomes are still awaited. The drawbacks of existing studies on alignment include the use of surgical techniques with limited accuracy and reproducibility of achieving the planned alignment, poor correlation of intraoperative data to long-term functional outcomes and implant survivorship, and a paucity of studies on the safe ranges of limb alignment. Further studies on alignment in TKA should use surgical adjuncts (e.g. robotic technology) to help execute the planned alignment with improved accuracy, include intraoperative assessments of knee biomechanics and periarticular soft-tissue tension, and correlate alignment to long-term functional outcomes and survivorship.


Bone & Joint Open
Vol. 2, Issue 3 | Pages 191 - 197
1 Mar 2021
Kazarian GS Barrack RL Barrack TN Lawrie CM Nunley RM

Aims

The purpose of this study was to compare the radiological outcomes of manual versus robotic-assisted medial unicompartmental knee arthroplasty (UKA).

Methods

Postoperative radiological outcomes from 86 consecutive robotic-assisted UKAs (RAUKA group) from a single academic centre were retrospectively reviewed and compared to 253 manual UKAs (MUKA group) drawn from a prior study at our institution. Femoral coronal and sagittal angles (FCA, FSA), tibial coronal and sagittal angles (TCA, TSA), and implant overhang were radiologically measured to identify outliers.


Bone & Joint 360
Vol. 8, Issue 3 | Pages 3 - 7
1 Jun 2019
Patel NG Waterson HB Phillips JRA Toms AD


The Bone & Joint Journal
Vol. 101-B, Issue 7_Supple_C | Pages 115 - 120
1 Jul 2019
Hooper J Schwarzkopf R Fernandez E Buckland A Werner J Einhorn T Walker PS

Aims

This aim of this study was to assess the feasibility of designing and introducing generic 3D-printed instrumentation for routine use in total knee arthroplasty.

Materials and Methods

Instruments were designed to take advantage of 3D-printing technology, particularly ensuring that all parts were pre-assembled, to theoretically reduce the time and skill required during surgery. Concerning functionality, ranges of resection angle and distance were restricted within a safe zone, while accommodating either mechanical or anatomical alignment goals. To identify the most suitable biocompatible materials, typical instrument shapes and mating parts, such as dovetails and screws, were designed and produced.