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Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_11 | Pages 2 - 2
4 Jun 2024
Townshend D Bing A Clough T Sharpe I Blundell C Davenport J Davies H Davis J Dhar S Goldberg A Karski M Hepple S Kakwani R McKinley J Murty A Ragland M Shalaby H Smith R Taylor H
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Introduction. This is a multi-centre, prospective, observational study of 503 INFINITY fixed bearing total ankle arthroplasties. We report the minimum two-year results of this prosthesis which was introduced to the UK Market in 2014 and is now the most used ankle arthroplasty in the National Joint Registry of England and Wales. Methods. Patients were recruited from 11 centres in the United Kingdom between June 2016 and November 2019. Demographic, radiographic, and functional outcome data (Ankle Osteoarthritis Scale, Manchester Oxford Foot Ankle Questionnaire and Euroquol 5D-5L) were collected preoperatively, at 6 months, 1 year and 2 years and 5 years. The average age was 67.8 (range 23.9 to 88.5) and average BMI 29.3 (18.9 to 48.0). The COFAS grading system was used to stratify deformity. There were 261 (51.9%) COFAS Type 1, 122 (24.2%) COFAS Type 2, 31 (6.2%) COFAS 3 and 89 (17.7%) COFAS type 4. 38 patients (7.6%) presented with inflammatory arthritis. 99 (19.7%) implantations utilised patient specific instrumentation. Complications and reoperations were recorded as adverse events. Radiographs were assessed for lucencies, cysts and/or subsidence. Results. The mean follow up was 34.2 months (range 24–64). 15 patients have died, 8 withdrawn and 3 lost to follow up. 8 implants (1.6%) have been revised. According to the Glazebrook classification there were low grade complications in 6.6%, medium grade in 1.4% and high grade in 1.6%. There have been an additional 13 non revision re-operations (2.6%) at the latest follow up. There was a significant (p < 0.01) improvement across all functional outcome scores at a minimum of 2yr follow up. Discussion and conclusion. This large cohort has shown a low early revision rate and high functional outcomes with a low-profile fixed bearing prosthesis


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_16 | Pages 54 - 54
17 Nov 2023
Bishop M Zaffagnini S Grassi A Fabbro GD Smyrl G Roberts S MacLeod A
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Abstract. Background. Distal femoral osteotomy is an established successful procedure which can delay the progression of arthritis and the need for knee arthroplasty. The surgery, however, is complex and lengthy and consequently it is generally the preserve of highly experienced specialists and thus not widely offered. Patient specific instrumentation is known to reduce procedural complexity, time, and surgeons’ anxiety levels. 1. in proximal tibial osteotomy procedures. This study evaluated a novel patient specific distal femoral osteotomy procedure (Orthoscape, Bath, UK) which aimed to use custom-made implants and instrumentation to provide a precision correction while also simplifying the procedure so that more surgeons would be comfortable offering the procedure. Presenting problem. Three patients (n=3) with early-stage knee arthritis presented with valgus malalignment, the source of which was predominantly located within the distal femur, rather than intraarticular. Using conventional techniques and instrumentation, distal femoral knee osteotomy cases typically require 1.5–2 hours surgery time. The use of bi-planar osteotomy cuts have been shown to improve intraoperative stability as well as bone healing times. 2. This normally also increases surgical complexity; however, multiple cutting slots can be easily incorporated into patient specific instrumentation. Clinical management. All three cases were treated at a high-volume tertiary referral centre (Istituto Ortopedico Rizzoli, Bologna) using medial closing wedge distal femoral knee osteotomies by a team experienced in using patient specific osteotomy systems. 3. Virtual surgical planning was conducted using CT-scans and long-leg weight-bearing x-rays (Orthoscape, Bath, UK). Patient specific surgical guides and custom-made locking plates were design for each case. The guides were designed to allow temporary positioning, drilling and bi-planar saw-cutting. The drills were positioned such that the drills above and below the osteotomy became parallel on closing following osteotomy wedge removal. This gave reassurance of the achieved correction allowed the plate to be located precisely over the drills. All screw lengths were pre-measured. Discussion. The surgical time reduced to approximately 30 minutes by the third procedure. It was evident that surgical time was saved because no intraoperative screw length measurements were required, relatively few x-rays were used to confirm the position of the surgical guide, and the use of custom instrumentation significantly reduced the surgical inventory. The reduced invasiveness and ease of surgery may contribute to faster patient recovery compared to conventional techniques. The final post-operative alignment was within 1° of the planned alignment in all cases. Declaration of Interest. (a) fully declare any financial or other potential conflict of interest


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 60 - 60
4 Apr 2023
MacLeod A Mandalia V Mathews J Toms A Gill H
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High tibial osteotomy (HTO) is an effective surgical treatment for isolated medial compartment knee osteoarthritis; however, widespread adoption is limited due to difficulty in achieving the planned correction, and patient dissatisfaction due to soft tissue irritation. A new HTO system – Tailored Osteotomy Knee Alignment (TOKA®, 3D Metal Printing Ltd, Bath, UK) could potentially address these barriers having a custom titanium plate and titanium surgical guides featuring a unique mechanism for precise osteotomy opening as well as saw cutting and drilling guides. The aim of this study was to assess the accuracy of this novel HTO system using cadaveric specimens; a preclinical testing stage ahead of first-in-human surgery according to the ‘IDEAL-D’ framework for device innovation. Local ethics committee approval was obtained. The novel opening wedge HTO procedure was performed on eight cadaver leg specimens. Whole lower limb CT scans pre- and post-operatively provided geometrical assessment quantifying the discrepancy between pre-planned and post-operative measurements for key variables: the gap opening angle and the patient specific surgical instrumentation positioning and rotation - assessed using the implanted plate. The average discrepancy between the pre-operative plan and the post-operative osteotomy correction angle was: 0.0 ± 0.2°. The R2 value for the regression correlation was 0.95. The average error in implant positioning was −0.4 ± 4.3 mm, −2.6 ± 3.4 mm and 3.1 ± 1.7° vertically, horizontally, and rotationally respectively. This novel HTO surgery has greater accuracy and smaller variability in correction angle achieved compared to that reported for conventional or other patient specific methods with published data available. This system could potentially improve the accuracy and reliability of osteotomy correction angles achieved surgically


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_2 | Pages 118 - 118
10 Feb 2023
Sundaraj K Corbett J Yong Yau Tai J Salmon L Roe J
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The emergence of patient specific instrumentation has seen an expansion from simple radiographs to plan total knee arthroplasty (TKA) with modern systems using computed tomography (CT) or magnetic resonance imaging scans. Concerns have emerged regarding accuracy of these non-weight bearing modalities to assess true mechanical axis. The aim of our study was to compare coronal alignment on full length standing AP imaging generated by the EOS acquisition system with the CT coronal scout image. Eligible patients underwent unilateral or bilateral primary TKA for osteoarthritis under the care of investigating surgeon between 2017 and 2022, with both EOS X-Ray Imaging Acquisition System and CT scans performed preoperatively. Coronal mechanical alignment was measured on the supine coronal scout CT scan and the standing HKA EOS. Pre-operative lower limb coronal alignment was assessed on 96 knees prior to TKA on the supine coronal scout CT scan and the standing HKA EOS. There were 56 males (56%), and 44 right knees (44%). The mean age was 68 years (range 53-90). The mean coronal alignment was 4.7 degrees (SD 5.3) on CT scan and 4.6 degrees (SD 6.2) on EOS (p=0.70). There was a strong positive correlation of coronal alignment on CT scan and EOS (pearson. 0.927, p=0.001). The mean difference between EOS and CT scan was 0.9 degrees (SD 2.4). Less than 3 degrees variation between measures was observed in 87% of knees. On linear regression for every 1° varus increase in CT HKA alignment, the EOS HKA alignment increased by 0.93° in varus orientation. The model explained 86% of the variability. CT demonstrates excellent reliability for assessing coronal lower limb alignment compared to EOS in osteoarthritic knees. This supports the routine use of CT to plan TKA without further weight bearing imaging in routine cases


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_1 | Pages 11 - 11
1 Jan 2022
Cheruvu MS Ganapathi M
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Abstract. Background. Conventional TKR aims for neutral mechanical alignment which may result in a smaller lateral distal femoral condyle resection than the implant thickness. We aim to explore the mismatch between implant thickness and bone resection using 3D planning software used for Patient Specific Instrumentation (PSI) TKR. Methods. This is a retrospective anatomical study from pre-operative MRI 3D models for PSI TKR. Cartilage mapping allowed us to recreate the native anatomy, enabling us to quantify the mismatch between the distal lateral femoral condyle resection and the implant thickness. Results. We modelled 292 knees from PSI TKR performed between 2012 and 2015. There were 225 varus knees and 67 valgus knees, with mean supine hip-knee-angle of 5.6±3.1 degrees and 3.6±4.6 degrees, respectively. In varus knees, the mean cartilage loss from medial and lateral femoral condyle was 2.3±0.7mm and 1.1±0.8mm respectively; the mean overstuffing of the lateral condyle 1.9±2.2mm. In valgus knees, the mean cartilage loss from medial and lateral condyle was 1.4±0.8mm and 1.5±0.9mm respectively; the mean overstuffing of the lateral condyle was 4.1±1.9mm. Conclusions. Neutral alignment TKR often results in overstuffing of the lateral condyle. This may increase the patello-femoral pressure at the lateral facet in flexion. Anterior knee pain may be persistent even after patellar resurfacing due to tight lateral retinacular structures. An alternative method of alignment such as anatomic alignment may minimise this problem


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


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.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_11 | Pages 83 - 83
1 Dec 2020
Shah DS Taylan O Labey L Scheys L
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Understanding the long-term effects of total knee arthroplasty (TKA) on joint kinematics is vital to assess the success of the implant design and surgical procedure. However, while in vitro cadaveric studies quantifying post-operative biomechanics primarily reflect joint behaviour immediately after surgery,. 1. in vivo studies comprising of follow-up TKA patients often reflect joint behaviour a few months after surgery. 2. Therefore, the aim of this cadaveric study was to explore the long-term effects of TKA on tibiofemoral kinematics of a donor specimen, who had already undergone bilateral TKA, and compare them to post-operative kinematics reported in the literature. Two fresh-frozen lower limbs from a single donor (male, age: 83yr, ht: 1.83m, wt: 86kg), who had undergone bilateral TKA (Genesis II, Smith&Nephew, Memphis, USA) 19 years prior to his demise, were obtained following ethical approval from the KU Leuven institutional board. The specimens were imaged using computed tomography (CT) and tested in a validated knee simulator. 3. replicating active squatting and varus-valgus laxity tests. Tibiofemoral kinematics were recorded using an optical motion capture system and compared to various studies in the literature using the same implant – experimental studies based on cadaveric specimens (CAD). 1,4. and an artificial specimen (ART). 5. , and a computational study (COM). 6. . Maximum tibial abduction during laxity tests for the left leg (3.54°) was comparable to CAD (3.30°), while the right leg exhibited much larger joint laxity (8.52°). Both specimens exhibited valgus throughout squatting (left=2.03±0.57°, right=5.81±0.19°), with the change in tibial abduction over the range of flexion (left=1.89°, right=0.64°) comparable to literature (CAD=1.28°, COM=2.43°). The left leg was externally rotated (8.00±0.69°), while the right leg internally rotated (−15.35±1.50°), throughout squatting, with the change in tibial rotation over the range of flexion (left=2.61°, right=4.79°) comparable to literature (CAD=5.52°, COM=4.15°). Change in the femoral anteroposterior translation over the range of flexion during squatting for both specimens (left=14.88mm, right=6.76mm) was also comparable to literature (ART=13.40mm, COM=20.20mm). Although TKA was reportedly performed at the same time on both legs of the donor by the same surgeon, there was a stark difference in their post-operative joint kinematics. A larger extent of intraoperative collateral ligament release could be one of the potential reasons for higher post-operative joint laxity in the right leg. Relative changes in post-operative tibiofemoral kinematics over the range of squatting were similar to those reported in the literature. However, differences between absolute magnitudes of joint kinematics obtained in this study and findings from the literature could be attributed to different surgeons performing TKA, with presumable variations in alignment techniques and/or patient specific instrumentation, and the slightly dissimilar ranges of knee flexion during squatting. In conclusion, long-term kinematic effects of TKA quantified using in vitro testing were largely similar to the immediate post-operative kinematics reported in the literature; however, variation in the behaviour of two legs from the same donor suggested that intraoperative surgical alterations might have a greater effect on joint kinematics over time


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. 102-B, Issue SUPP_6 | Pages 20 - 20
1 Jul 2020
Ge S Barimani B Epure L Aoude A Luo L Volesky M Chaytor RE
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Recent innovations in total ankle replacement (TAR) have led to improvements in implant survivorship, accuracy of component positioning and sizing, and patient outcomes. CT-generated pre-operative plans and cutting guides show promising results in terms of placement enhancement and reproducibility in clinical studies. The purpose of this study was to determine the accuracy of 1) implant sizes used and 2) alignment corrections obtained intraoperatively using the cutting guides provided, compared to what was predicted in the CT generated pre-operative plans.

This is a retrospective study looking at 36 patients who underwent total ankle arthroplasty using a CT generated pre-operative planning system between July 2015 and December 2017. Personalized pre-operative planning data was obtained from the implant company. Two evaluators took measurements of the angle corrected using pre- and post-operative weight bearing ankle AP X-rays. All patients had a minimum three-month follow-up with weightbearing postoperative radiographs. The actual correction calculated from the radiographic assessment was compared with the predicted angles obtained from pre-operative plans. The predicted and predicted alternative component sizes and actual sizes used were also compared. If either a predicted or predicted alternative size was implanted, we considered it to be accurate.

Average age for all patients was 64 years (range 40–83), with a body mass index of 28.2 ± 5.6. All surgeries were performed by two foot and ankle surgeons. The average total surgical time was 110 ± 23 minutes. Pre-operative alignment ranged from 36.7 degrees valgus to 20 degrees varus. Average predicted coronal alignment correction was 0.8 degrees varus ± 9.3 degrees (range, 18.2 degrees valgus to 29 degrees varus) and average correction obtained was 2.1 degrees valgus ± 11.1 degrees. Average post-op alignment was consistently within 5 degrees of neutral. There were no significant differences between the predicted alignments and the postoperative weightbearing alignments. The predicted tibia implant size was accurate in all cases. The predicted sizes were less accurate for talar implants and predicted the actual talar implant size used in 66% of cases. In all cases of predicted talar size mismatch, surgical plans predicted 1 implant size larger than used.

Preliminary analyses of our data is comparable to previous studies looking at similar outcomes. However, our study had higher pre-operative deformities. Despite that, post-op alignments were consistently within 5 degress of neutral with no significant difference between the predicted and actual corrections. Tibial implant sizes are highly accurate while talar implant sizes had a trend of being one size smaller than predicted. Moreover, this effect seems to be more pronounced in the earlier cases likely reflective of increasing surgeon comfort with the implant with each subsequent case. These results confirm that pre-operative cutting guides are indeed helpful in intra-operative implant selection and positioning, however, there is still some room for innovation.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 779 - 787
1 Jun 2020
Gupta S Griffin AM Gundle K Kafchinski L Zarnett O Ferguson PC Wunder J

Aims

Iliac wing (Type I) and iliosacral (Type I/IV) pelvic resections for a primary bone tumour create a large segmental defect in the pelvic ring. The management of this defect is controversial as the surgeon may choose to reconstruct it or not. When no reconstruction is undertaken, the residual ilium collapses back onto the remaining sacrum forming an iliosacral pseudarthrosis. The aim of this study was to evaluate the long-term oncological outcome, complications, and functional outcome after pelvic resection without reconstruction.

Methods

Between 1989 and 2015, 32 patients underwent a Type I or Type I/IV pelvic resection without reconstruction for a primary bone tumour. There were 21 men and 11 women with a mean age of 35 years (15 to 85). The most common diagnosis was chondrosarcoma (50%, n = 16). Local recurrence-free, metastasis-free, and overall survival were assessed using the Kaplan-Meier method. Patient function was evaluated using the Musculoskeletal Tumour Society (MSTS) and Toronto Extremity Salvage Score (TESS).


The use of Patient Reported Outcome Measures (PROMS) has been critical to the success of total joint arthroplasty (TJA). They have made possible the evaluations of new implants, materials and surgical techniques that have been essential to the development of these technologies. PROMS have had a major impact on the decisions that surgeons make regarding treatment and care of patients. However, there are serious limitations of PROMS. They are useless in the first few weeks after surgery. They provide very little objective functional information to which health care providers can respond in the early, critical post-operative period. PROMS do not objectively measure specific outcome measures (e.g. ROM, distance walked). PROMS are also cumbersome and time consuming to use. Joint specific surface sensors are emerging to allow objective measurements of specific functional outcomes of knee surgery. This allows an examination of the factors that might affect these functional outcomes. The purpose of this study was to examine the relationship of age, gender, BMI and pain following TKA on ROM and activity measured using a joint specific surface sensor. Methods. 40 patients who underwent primary cruciate retaining TKA using the same implant system and patient specific instrumentation (PSI) were followed for 3 weeks with a knee specific surface sensor (TracPatch. tm. ). The device was applied one day following surgery. Standard post-TKA care protocols were used. The ROM and distance walked was measured by the device. The relationship of these outcomes to patients’ age, gender, BMI and pain were examined. Results. All but one patient tolerated the device. This patient had a superficial, transient skin reaction to the adhesive and was not included in the study. Patients under 60 regained more motion and were more active in the first 3 weeks after surgery than patients 60–69 and patients 70+. Gender had no significant impact on ROM or activity for each age group. BMI under 30 had no impact on ROM or activity. BMI over 40 had a significant impact on both ROM and activity. Pain had very little impact on ROM and moderate impact on activity in the first 3 weeks after surgery. Summary. Joint specific sensors are becoming available to provide objective measurements of a joint's function. The knee specific sensors used in this study measured the number of steps taken and ROM in patients who underwent a primary, cruciate retaining TKA. The device was liked and well tolerated by patients. ROM was affected by age and BMI, but not by gender or, to a significant degree, by pain. The device will be useful in focusing therapy on those patients who most need it. Use of the device has the potential of making post-surgical care more effective and cost efficient


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


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. Results. Four UKA to TKA surgeries have been performed using revision PSI guides. The maximum difference from planned to achieved component alignments are: Femoral valgus = 2.4â□°, Tibial varus = 2.5â□°, Femoral internal rotation = 3.6â□°, Femoral flexion = 5.1â□° and tibial slope = 2.9â□°, see boxplot of results in Figure 2. All median values are within 2.5â□° of the planned alignment. A further five cases are to be analysed. Conclusions. A PSI guide designed for UKR to TKR revision surgery has been successfully used in surgery with acceptable errors. A larger study must be performed to determine the reliability and reproducibility of the design and method over a wide range of patient anatomy and UKA imaging flare


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. Results. There were no differences (p > 0.05) between the PSI and CI groups for demographics or pre- and post-operative patient reported outcome scores. Three patients in the PSI group and seven patients in the CI group (p = 0.28) had a post-operative limb alignment outside of the neutral target (>3° varus or valgus). There was no difference in the change of tibial slope from pre- to post-operation between groups (p = 0.49). There were no differences (p > 0.05) in translations or rotations in any individual plane across all time points for either the tibial or femoral components. Maximum total point motion (MTPM) at 6 months for the tibial component was 0.54 ± 0.25 mm in the CI group and 0.51 ± 0.22 mm in the PSI group (p = 0.77), placing both groups at the low end of the “at risk” category for predicted loosening. Change in MTPM from 6 months to 1 year and again from 1 year to 2 years was <0.2 mm, indicating both groups of implants had stable fixation. Femoral component MTPM was also not different (p > 0.05) between groups. There was no significant difference between PSI and CI groups with respect to magnitude of excursion on both medial (p = 0.54) and lateral (p = 0.81) condyles. There was also no difference in contact locations on both the medial and lateral condyles (p = 0.28 to 0.91) for all angles of flexion. There was no significant difference present between PSI and CI groups when comparing the stability for both the medial (p = 0.06) and lateral (= 0.85) condyles. Condylar separation was present in 3/20 CI patients and 0/16 PSI patients (p = 0.24). Conclusion. Using the latest RSA criteria for predicting failure from early migration, the use of PSI does not provide an advantage over CI for preventing aseptic loosening. Moreover, PSI did not provide any substantial advantage over CI for TKA surgery with respect to contact kinematics


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_10 | Pages 112 - 112
1 Jun 2018
Vince K
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The most recent Australian registry has a database of 547,407 knee arthroplasties, having added over 52,000 in 2016. Total knee arthroplasties (TKA) comprise 83.8%, revisions (RevTKA) 8.1% and “partials of all types” 8.1%. Since 2003, the percent of TKA has increased from 76.7%, RevTKA has stayed stable and partial replacements have declined from 14.5%. In the last year, however, TKA declined slightly. There is a slightly higher percentage of women (56.1%) undergoing TKA and this has remained very stable since 2003. Revision rates are slightly higher for men. Percentages of the youngest (<55) and oldest (>85) are small and stable. The 75–84 year olds have declined as 55–74 year olds have increased. This represents a gradual shift to earlier TKA surgery. More patella are resurfaced and this is a gradual trend with a cross over in 2010 when half were resurfaced. Computer navigation is progressively more popular and now accounts for almost 30% of cases. Cement fixation is also increasing and accounts for about 65% of cases. Crosslinked polyethylene is gradually replacing non crosslinked and in 2014 was used in 50% of cases. Revisions are performed most commonly for loosening and infection. Revision rates correlate directly with age. Loosening is the most common indication for revision in both genders, but males have a distinctly higher revision rate due to infection. Revision rates are slightly higher in all forms of mobile bearing than fixed bearing. Minimally constrained (cruciate retaining) devices are used in the majority of TKAs. Posterior stabilised implants are in slight decline, having peaked in about 2008–2010. Minimally constrained implants are in slight decline as medial pivot/medial congruent devices have been used more frequently. Revision rates are similar amongst all three implant types: PS implants are revised at a slightly higher rate. When an early Medial Pivot (MP) implant is excluded the newer version has better results. The reasons for revision are similar amongst all 3 groups with slightly higher loosening rates for PS designs. (Could this represent backside wear with older locking mechanisms, surface finish and non crosslinked poly?) The MP designs had slightly higher revision rates for “pain”, which is not recognised as a reasonable indication for revision. Revision rates are steadily higher for TKAs without patella resurfacing over 16 years, but the questions as to whether: i. the surgeries were secondary resurfacings or full revisions or ii. if secondary resurfacings eliminated pain are unknown. The combinations at greatest risk of revision were a posterior stabilised or medial pivot arthroplasty without patellar resurfacing. Cementless fixation leads to a higher revision rate. If age and computer navigation are evaluated in terms of revision rates, young patients with and without computer navigated arthroplasties failed at the highest rates, distinct from patients >65. However, if failure rates due only to loosening are evaluated, then computer navigation leads to a lower revision rate in the <65 group. This has been interpreted as the protective effect of better component position that only shows up in patients who use the arthroplasty more aggressively. Patient specific instrumentation (PSI) or Individual Designed Instrumentation (IDI) were revised at marginally higher rates than conventional instrumentation. Crosslinked polyethylene appears to be superior at 12 years (CRR= 4%) versus non crosslinked polyethylene (CRR>7%). This is the result of fewer failures due to loosening with crosslinked poly. The superiority of crosslinked poly was greater in the younger, more active patient


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. Results. The mean age of the cohort was 72.9±7.5years (range, 55–85years). The study included 11men and 55women, with a mean height of 151±8.2cm (range, 135–175cm), mean weight of 59.4±4.3kg (range, 42–82kg), and a mean of Body Mass Index of 25.9±3.6 (range, 17.2–36.4). HKA angle (supine position) measured by CT was 170.8 ±4.4 degree(range, 162.5–182degree). Diagnosis was osteoarthritis in all patient. There was no statistically significant difference in PSI position alignment for femoral flexion, tibial coronal angle, tibial slope between the two groups with two examiners. However, the intraoperative coronal position using the femoral STD PSI significantly deviated from using femoral MIS PSI from both examiners. (PSI vs. MIS, examiner1 p = 0.02, examiner2 p=0.04)


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


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_20 | Pages 35 - 35
1 Dec 2017
Bosma S Jutte P Wong K Paul L Gerbers J
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Computer Assisted Surgery (CAS) and Patient Specific Instrumentation (PSI) have been reported to increase accuracy and predictability of tumour resections. The technically demanding joint-preserving surgery that retains the native joint with the better function may benefit from the new techniques. This cadaver study is to investigate the surgical accuracy of CAS and PSI in joint-preserving surgery of knee joint. CT scans of four cadavers were performed and imported into an engineering software (MIMICS, Materialise) for the 3D surgical planning of simulated, multiplanar joint-preserving resections for distal femur or proximal tibia metaphyseal bone sarcoma. The planned resections were transferred to the navigation system (OrthoMap 3D, Stryker) for navigation planning and used for the design and fabrication of the PSI. Each of the four techniques (freehand, CAS, PSI and CAS + PSI) was used in four joint-preserving resections. Location accuracy (the maximum deviation of distance between the planned and the achieved resections) and bone resection time were measured. The results were compared by using t-test (statistically significant if P< 0.05). Both the CAS+PSI and PSI techniques could reproduce the planned resections with a mean location accuracy of < 2 mm, compared to 3.6 mm for CAS assistance and 9.2 mm for the freehand technique. There was no statistical difference in location accuracy between the CAS+PSI and the PSI techniques (p=0.92) but a significant difference between the CAS technique and the CAS+PSI (p=0.042) or PSI technique (p=0.034) and the freehand technique with the other assisted techniques. The PSI technique took the lowest mean time of 4.78 ±0.97min for bone resections. This was significantly different from the CAS+PSI technique (mean 12.78 min; p < 0.001) and the CAS technique (mean 16.97 min; p = < 0.001). CAS and PSI assisted techniques help reproduce the planned multiplanar resections. The PSI technique could achieve the most accurate bone resections (within 2mm error) with the least time for bone resections. Combining CAS with PSI might not improve surgical accuracy and might increase bone resection time. However, PSI placement on the bone surface depends only on the subjective feeling of surgeons and may not apply if the extraosseous tumor component is large. Combining CAS with PSI could address the limitations


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_6 | Pages 49 - 49
1 Mar 2017
Twiggs J Theodore W Liu D Dickison D Bare J Miles B
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Introduction. Surgical planning for Patient Specific Instrumentation (PSI) in total knee arthroplasty (TKA) is based on static non-functional imaging (CT or MRI). Component alignment is determined prior to any assessment of clinical soft tissue laxity. This leads to surgical planning where assumptions of correctability of preoperative deformity are false and a need for intraoperative variation or abandonment of the PSI blocks occurs. The aim of this study is to determine whether functional radiology complements pre-surgical planning by identifying non-predictable patient variation in laxity. Method. Pre-operative CT's, standing radiographs and functional radiographs assessing coronal laxity at 20° flexion were collected for 20 patients. Varus/valgus laxity was assessed using the TELOS stress device (TELOS GmbH, Marburg, Germany, see Figure 1). The varus/valgus load was incrementally increased to either a maximum load of 150N or until the patient could not tolerate the discomfort. Radiographs were taken whilst the knee was held in the stressed position. CT scans were segmented and anatomical points landmarked. 2D–3D pose estimations were performed using the femur and tibia against the radiographs to determine knee alignment with each functional radiograph and so characterise the varus/valgus laxity. Results. The mean coronal alignment on CT and standing radiographs were 3.8° varus (SD, 5.6°) and 4.3° varus (SD, 6.7°) respectively. Of these, 5 of the knees were valgus aligned and 15 varus aligned in both standing and CT positions. The varus group had a mean of 5.9° in CT and 6.9° varus standing, while the valgus group had means of 4.4° valgus and 5.4° valgus in standing, indicating a collapse into further coronal malalignment while weightbearing. Each knee in the group had a laxity envelope calculated from the varus and valgus stressed radiographs. In the varus knees, the envelope ranged from 11.0° to 1.0° degree, with a mean of 5.1° (SD, 2.4°). In the valgus knees, the envelope ranged from 10.0° to 5.0° degrees, with a mean of 6.6° (SD, 2.3°), though this difference did not reach statistical significance. Using ±3° of neutral alignment as an indicator of correctable deformity, 7 of the 15 varus knees did not have a correctable deformity, while all of the valgus did. As determined by laxity limits, the CT and standing alignments were not well centered within their functional radiology groups. Specifically, for the valgus knees, 2 were near the valgus limit (lower quartile) of their laxity envelope, while for the varus knees, 9 were near their varus limit (upper quartile) and 2 at the valgus limit. In total, 65% of the knees did not have their standing alignment well centered on their functional laxity imits. Conclusions. Varus/valgus laxity in TKA appears to be subject specific and divorced from static radiological parameters. Surgical planning without reproducible clinical assessments of coronal laxity may not be sufficient to obtain a balanced TKA while avoiding ligament releases. Functional radiographs may be a viable method to individualise and refine the surgical plan in TKA on a per patient basis, incorporating objective information normally only available during the surgery itself. For any figures or tables, please contact authors directly (see Info & Metrics tab above).