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Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.

ABSTRACT: INTRODUCTION:Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The primary hypothesis of this study is that achieving knee balance with use of sensors in TKA will improve patient-reported outcomes when compared with manual balancing. METHODS AND ANALYSIS:A multicentred, randomised controlled trial will compare patient-reported outcomes in 222 patients undergoing TKA using sensor-guided balancing versus manual balancing. The sensor will be used in both arms for purposes of data collection; however, surgeons will be blinded to the pressure data in patients randomised to manual balancing. The primary outcome will be the change from baseline to 1?year postoperatively in the mean of the four subscales of the Knee Injury and Osteoarthritis Outcome Score (KOOS4) that are most specific to TKA recovery: pain, symptoms, function and knee-related quality of life. Secondary outcomes will include the surgeon's capacity to determine knee balance, radiographic and functional measures and additional patient-reported outcomes. Normality of data will be assessed, and a Student's t-test and equivalent non-parametric tests will be used to compare differences in means among the two groups. ETHICS AND DISSEMINATION:Ethics approval was obtained from South Eastern Sydney Local Health District, Approval (HREC/18/POWH/320). Results of the trial will be presented at orthopaedic surgical meetings and submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER:ACTRN#12618000817246.

SUBMITTER: MacDessi SJ

PROVIDER: S-EPMC6530442 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.

MacDessi Samuel J SJ Bhimani Aziz A Burns Alexander W R AWR Chen Darren B DB Leong Anthony K L AKL Molnar Robert B RB Mulford Jonathan S JS Walker Richard M RM Harris Ian A IA Diwan Ashish A Wood Jil A JA

BMJ open 20190510 5

<h4>Introduction</h4>Soft tissue imbalance is considered to be a major surgical cause of dissatisfaction following total knee arthroplasty (TKA). Surgeon-determined manual assessment of ligament tension has been shown to be a poor determinant of the true knee balance state. The recent introduction of intraoperative sensors, however, allows surgeons to precisely quantify knee compartment pressures and tibiofemoral kinematics, thereby optimising coronal and sagittal plane soft tissue balance. The ...[more]

PMID: 31079087

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Project description:BackgroundSoft-tissue releases are commonly necessary to achieve symmetrical flexion and extension gaps in primary total knee arthroplasty performed with a measured resection technique. We reviewed the frequency of required releases according to preoperative alignment and the clinical and radiographic results; associations with failure, reoperations, and complications are presented.MethodsWe reviewed 1216 knees that underwent primary total knee arthroplasty from 2004 to 2009; 774 (64%) were in female patients and 442 (36%), in male patients. In the coronal plane, 855 knees had preoperative varus deformity, 123 were neutral, and 238 had valgus deformity. The mean age at the time of the index procedure was 62.7 years (range, twenty-three to ninety-four years), and the mean body mass index was 32.7 kg/m² (range, 17.4 to 87.9 kg/m²). Clinical outcomes included the Knee Society Score (KSS), implant failure, reoperation, and complications. Radiographs were analyzed for component alignment.ResultsThe only difference in the total KSS was found at the time of final follow-up between valgus knees with zero releases (total KSS = 178) and those with one or two releases (KSS = 160, p = 0.026). Overall, 407 knees (33.5%) required zero releases, 686 (56.4%) required one or two releases, and 123 (10.1%) required three or more releases. Among varus knees, 37% required zero releases, 55% required one or two releases, and 7.5% required three or more releases. Among neutral knees, 39% required zero releases, 55% required one or two releases, and 5.7% required three or more releases. Only 17% of valgus knees required zero releases whereas 61% required one or two releases and 21.8% required three or more releases. Valgus knees required more releases than neutral or varus knees did (p < 0.001).ConclusionsSelective soft-tissue release for gap balancing in primary total knee arthroplasty is an effective technique that produced excellent clinical and radiographic results regardless of preoperative alignment. Consistent anatomic coronal-plane alignment and soft-tissue balance could be achieved without bone cut modification by using measured bone resection and selective soft-tissue release.

Project description:BackgroundThis meta-analysis was designed to compare the accuracy of soft tissue balancing and femoral component rotation as well as change in joint line positions, between the measured resection and gap balancing techniques in primary total knee arthroplasty.MethodsStudies were included in the meta-analysis if they compared soft tissue balancing and/or radiologic outcomes in patients who underwent total knee arthroplasty with the gap balancing and measured resection techniques. Comparisons included differences in flexion/extension, medial/lateral flexion, and medial/lateral extension gaps (LEGs), femoral component rotation, and change in joint line positions. Finally, 8 studies identified via electronic (MEDLINE, EMBASE, and the Cochrane Library) and manual searches were included. All 8 studies showed a low risk of selection bias and provided detailed demographic data. There was some inherent heterogeneity due to uncontrolled bias, because all included studies were observational comparison studies.ResultsThe pooled mean difference in gap differences between the gap balancing and measured resection techniques did not differ significantly (-0.09 mm, 95% confidence interval [CI]: -0.40 to +0.21 mm; P = 0.55), except that the medial/LEG difference was 0.58 mm greater for measured resection than gap balancing (95% CI: -1.01 to -0.15 mm; P = 0.008). Conversely, the pooled mean difference in femoral component external rotation (0.77°, 95% CI: 0.18° to 1.35°; P = 0.01) and joint line change (1.17 mm, 95% CI: 0.82 to 1.52 mm; P < 0.001) were significantly greater for the gap balancing than the measured resection technique.ConclusionThe gap balancing and measured resection techniques showed similar soft tissue balancing, except for medial/LEG difference. However, the femoral component was more externally rotated and the joint line was more elevated with gap balancing than measured resection. These differences were minimal (around 1 mm or 1°) and therefore may have little effect on the biomechanics of the knee joint. This suggests that the gap balancing and measured resection techniques are not mutually exclusive.

Project description:BACKGROUND:Total knee arthroplasty (TKA) is the treatment option for patients with severe osteoarthritis (OA) of the knee whose symptoms are refractory to conservative management. Unfortunately, the level of patient dissatisfaction is high, reaching up to 25%. The reasons for this dissatisfaction are multifactorial, but bone-implant mismatch significantly increases the chance of pain and functional limitation. Sex-specific prosthesis designs have been developed to overcome this issue, but their use is still controversial. The primary objective of this study was to evaluate possible sex differences in the shape of the distal femur in patients with osteoarthritis. Secondary objectives were to investigate interpersonal variability of the distal femur and to determine the number of femoral implant sizes required to meet shape variations. METHODS AND FINDINGS:A cross-sectional observational study prospectively compared 294 knees of 293 patients with osteoarthritis according to sex (201 female/93 male). Six intraoperative measurements were performed on the distal femur (height and width of both lateral and medial condyles, total medial-lateral width of the femur, and intercondylar distance). Sex differences and interpersonal variability were analyzed by multiple linear regressions. Measurements were also correlated with patient height. An optimization analysis was used to estimate the number of femoral implant sizes required. There were significant sex differences in the distal femur, where men had higher values than women in all measurements. Great interpersonal variability was found. The height of the lateral condyle was correlated with patient height, but the correlation was not strong. Twenty-five femoral implant sizes were required to meet the shape variations in our sample. CONCLUSIONS:The shape of the distal femur in patients with osteoarthritis shows great interpersonal variability, with men showing significantly higher values than women. A total of 25 different implant sizes would be necessary to adequately meet the variations observed in our study population.

Dataset Information

Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.

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Does soft tissue balancing using intraoperative pressure sensors improve clinical outcomes in total knee arthroplasty? A protocol of a multicentre randomised controlled trial.

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