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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


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. 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
Full Access

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.


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


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.


The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1043 - 1049
1 Aug 2016
Huijbregts HJTAM Khan RJK Fick DP Hall MJ Punwar SA Sorensen E Reid MJ Vedove SD Haebich S

Aims

We conducted a randomised controlled trial to assess the accuracy of positioning and alignment of the components in total knee arthroplasty (TKA), comparing those undertaken using standard intramedullary cutting jigs and those with patient-specific instruments (PSI).

Patients and Methods

There were 64 TKAs in the standard group and 69 in the PSI group.

The post-operative hip-knee-ankle (HKA) angle and positioning was investigated using CT scans. Deviation of > 3° from the planned position was regarded as an outlier. The operating time, Oxford Knee Scores (OKS) and Short Form-12 (SF-12) scores were recorded.


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 354 - 359
1 Mar 2013
Chareancholvanich K Narkbunnam R Pornrattanamaneewong C

Patient-specific cutting guides (PSCGs) are designed to improve the accuracy of alignment of total knee replacement (TKR). We compared the accuracy of limb alignment and component positioning after TKR performed using PSCGs or conventional instrumentation. A total of 80 patients were randomised to undergo TKR with either of the different forms of instrumentation, and radiological outcomes and peri-operative factors such as operating time were assessed. No significant difference was observed between the groups in terms of tibiofemoral angle or femoral component alignment. Although the tibial component in the PSCGs group was measurably closer to neutral alignment than in the conventional group, the size of the difference was very small (89.8° (sd 1.2) vs 90.5° (sd 1.6); p = 0.030). This new technology slightly shortened the bone-cutting time by a mean of 3.6 minutes (p < 0.001) and the operating time by a mean 5.1 minutes (p = 0.019), without tangible differences in post-operative blood loss (p = 0.528) or need for blood transfusion (p = 0.789). This study demonstrated that both PSCGs and conventional instrumentation restore limb alignment and place the components with the similar accuracy. The minimal advantages of PSCGs in terms of consistency of alignment or operative time are unlikely to be clinically relevant.

Cite this article: Bone Joint J 2013;95-B:354–9.


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 83 - 83
1 Jul 2022
Dandridge O Garner A Amis A Cobb J Arkel RV
Full Access

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


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 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 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 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.


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.


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.


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.


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 660 - 666
1 Jun 2019
Chalmers BP Limberg AK Athey AG Perry KI Pagnano MW Abdel MP

Aims

There is little literature about total knee arthroplasty (TKA) after distal femoral osteotomy (DFO). Consequently, the purpose of this study was to analyze the outcomes of TKA after DFO, with particular emphasis on: survivorship free from aseptic loosening, revision, or any re-operation; complications; radiological results; and clinical outcome.

Patients and Methods

We retrospectively reviewed 29 patients (17 women, 12 men) from our total joint registry who had undergone 31 cemented TKAs after a DFO between 2000 and 2012. Their mean age at TKA was 51 years (22 to 76) and their mean body mass index 32 kg/m2 (20 to 45). The mean time between DFO and TKA was ten years (2 to 20). The mean follow-up from TKA was ten years (2 to 16). The prostheses were posterior-stabilized in 77%, varus-valgus constraint (VVC) in 13%, and cruciate-retaining in 10%. While no patient had metaphyseal fixation (e.g. cones or sleeves), 16% needed a femoral stem.


The Bone & Joint Journal
Vol. 98-B, Issue 10 | Pages 1360 - 1368
1 Oct 2016
Waterson HB Clement ND Eyres KS Mandalia VI Toms AD

Aims

Our aim was to compare kinematic with mechanical alignment in total knee arthroplasty (TKA).

Patients and Methods

We performed a prospective blinded randomised controlled trial to compare the functional outcome of patients undergoing TKA in mechanical alignment (MA) with those in kinematic alignment (KA). A total of 71 patients undergoing TKA were randomised to either kinematic (n = 36) or mechanical alignment (n = 35). Pre- and post-operative hip-knee-ankle radiographs were analysed. The knee injury and osteoarthritis outcome score (KOOS), American Knee Society Score, Short Form-36, Euro-Qol (EQ-5D), range of movement (ROM), two minute walk, and timed up and go tests were assessed pre-operatively and at six weeks, three and six months and one year post-operatively.