Arthroscopic partial meniscectomy versus physical therapy for traumatic meniscal tears in a young study population: a randomised controlled trial.

OBJECTIVE: To compare outcomes from arthroscopic partial meniscectomy versus physical therapy in young patients with traumatic meniscal tears. METHODS: We conducted a multicentre, open-labelled, randomised controlled trial in patients aged 18-45 years, with a recent onset, traumatic, MRI-verified, isolated meniscal tear without knee osteoarthritis. Patients were randomised to arthroscopic partial meniscectomy or standardised physical therapy with an optional delayed arthroscopic partial meniscectomy after 3-month follow-up. The primary outcome was the International Knee Documentation Committee (IKDC) score (best 100, worst 0) at 24 months, which measures patients' perception of symptoms, knee function and ability to participate in sports activities. RESULTS: Between 2014 and 2018, 100 patients were included (mean age 35.1 (SD 8.1), 76% male, 34 competitive or elite athletes). Forty-nine were randomised to arthroscopic partial meniscectomy and 51 to physical therapy. In the physical therapy group, 21 patients (41%) received delayed arthroscopic partial meniscectomy during the follow-up period. In both groups, improvement in IKDC scores was clinically relevant during follow-up compared with baseline scores. At 24 months mean (95% CI) IKDC scores were 78 (71 to 84) out of 100 points in the arthroscopic partial meniscectomy group and 78 (71 to 84) in the physical therapy group with a between group difference of 0.1 (95% CI -7.6 to 7.7) points out of 100. CONCLUSIONS: In this trial involving young patients with isolated traumatic meniscal tears, early arthroscopic partial meniscectomy was not superior to a strategy of physical therapy with optional delayed arthroscopic partial meniscectomy at 24-month follow-up. TRIAL REGISTRATION: https://www.trialregister.nl/trials.

An individualized decision between physical therapy or surgery for patients with degenerative meniscal tears cannot be based on continuous treatment selection markers: a marker-by-treatment analysis of the ESCAPE study.

PURPOSE: Marker-by-treatment analyses are promising new methods in internal medicine, but have not yet been implemented in orthopaedics. With this analysis, specific cut-off points may be obtained, that can potentially identify whether meniscal surgery or physical therapy is the superior intervention for an individual patient. This study aimed to introduce a novel approach in orthopaedic research to identify relevant treatment selection markers that affect treatment outcome following meniscal surgery or physical therapy in patients with degenerative meniscal tears. METHODS: Data were analysed from the ESCAPE trial, which assessed the treatment of patients over 45 years old with a degenerative meniscal tear. The treatment outcome of interest was a clinically relevant improvement on the International Knee Documentation Committee Subjective Knee Form at 3, 12, and 24 months follow-up. Logistic regression models were developed to predict the outcome using baseline characteristics (markers), the treatment (meniscal surgery or physical therapy), and a marker-by-treatment interaction term. Interactions with p < 0.10 were considered as potential treatment selection markers and used these to develop predictiveness curves which provide thresholds to identify marker-based differences in clinical outcomes between the two treatments. RESULTS: Potential treatment selection markers included general physical health, pain during activities, knee function, BMI, and age. While some marker-based thresholds could be identified at 3, 12, and 24 months follow-up, none of the baseline characteristics were consistent markers at all three follow-up times. CONCLUSION: This novel in-depth analysis did not result in clear clinical subgroups of patients who are substantially more likely to benefit from either surgery or physical therapy. However, this study may serve as an exemplar for other orthopaedic trials to investigate the heterogeneity in treatment effect. It will help clinicians to quantify the additional benefit of one treatment over another at an individual level, based on the patient's baseline characteristics. LEVEL OF EVIDENCE: II.

In patients eligible for meniscal surgery who first receive physical therapy, multivariable prognostic models cannot predict who will eventually undergo surgery.

PURPOSE: Although physical therapy is the recommended treatment in patients over 45 years old with a degenerative meniscal tear, 24% still opt for meniscal surgery. The aim was to identify those patients with a degenerative meniscal tear who will undergo surgery following physical therapy. METHODS: The data for this study were generated in the physical therapy arm of the ESCAPE trial, a randomized clinical trial investigating the effectiveness of surgery versus physical therapy in patients of 45-70 years old, with a degenerative meniscal tear. At 6 and 24 months patients were divided into two groups: those who did not undergo surgery, and those who did undergo surgery. Two multivariable prognostic models were developed using candidate predictors that were selected from the list of the patients' baseline variables. A multivariable logistic regression analysis was performed with backward Wald selection and a cut-off of p < 0.157. For both models the performance was assessed and corrected for the models' optimism through an internal validation using bootstrapping technique with 500 repetitions. RESULTS: At 6 months, 32/153 patients (20.9%) underwent meniscal surgery following physical therapy. Based on the multivariable regression analysis, patients were more likely to opt for meniscal surgery within 6 months when they had worse knee function, lower education level and a better general physical health status at baseline. At 24 months, 43/153 patients (28.1%) underwent meniscal surgery following physical therapy. Patients were more likely to opt for meniscal surgery within 24 months when they had worse knee function and a lower level of education at baseline at baseline. Both models had a low explained variance (16 and 11%, respectively) and an insufficient predictive accuracy. CONCLUSION: Not all patients with degenerative meniscal tears experience beneficial results following physical therapy. The non-responders to physical therapy could not accurately be predicted by our prognostic models. LEVEL OF EVIDENCE: III.

Can even experienced orthopaedic surgeons predict who will benefit from surgery when patients present with degenerative meniscal tears? A survey of 194 orthopaedic surgeons who made 3880 predictions.

OBJECTIVES: To examine the ability of surgeons to predict the outcome of treatment for meniscal tears by arthroscopic partial meniscectomy (APM) and exercise therapy in middle-aged patients. DESIGN AND SETTING: Electronic survey. Orthopaedic surgeon survey participants were presented 20 patient profiles. These profiles were derived from a randomised clinical trial comparing APM with exercise therapy in middle-aged patients with symptomatic non-obstructive meniscal tears. From each treatment group (APM and exercise therapy), we selected five patients with the best (responders) and five patients with the worst (non-responders) knee function after treatment. 1111 orthopaedic surgeons and residents in the Netherlands and Australia were invited to participate in the survey. INTERVENTIONS: For each of the 20 patient profiles, surgeons (unaware of treatment allocation) had to choose between APM and exercise therapy as preferred treatment and subsequently had to estimate the expected change in knee function for both treatments on a 5-point Likert Scale. Finally, surgeons were asked which patient characteristics affected their treatment choice. MAIN OUTCOMES: The primary outcome was the surgeons' percentage correct predictions. We also compared this percentage between experienced knee surgeons and other orthopaedic surgeons, and between treatment responders and non-responders. RESULTS: We received 194 (17%) complete responses for all 20 patient profiles, resulting in 3880 predictions. Overall, 50.0% (95% CI 39.6% to 60.4%) of the predictions were correct, which equals the proportion expected by chance. Experienced knee surgeons were not better in predicting outcome than other orthopaedic surgeons (50.4% vs 49.5%, respectively; p=0.29). The percentage correct predictions was lower for patient profiles of non-responders (34%; 95% CI 21.3% to 46.6%) compared with responders (66.0%; 95% CI 57.0% to 75.0%; p=0.01).In general, bucket handle tears, knee locking and failed non-operative treatment directed the surgeons' choice towards APM, while higher level of osteoarthritis, degenerative aetiology and the absence of locking complaints directed the surgeons' choice towards exercise therapy. CONCLUSIONS: Surgeons' criteria for deciding that surgery was indicated did not pass statistical examination. This was true regardless of a surgeon's experience. These results suggest that non-surgical management is appropriate as first-line therapy in middle-aged patients with symptomatic non-obstructive meniscal tears. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03462134.

How do the costs of physical therapy and arthroscopic partial meniscectomy compare? A trial-based economic evaluation of two treatments in patients with meniscal tears alongside the ESCAPE study.

OBJECTIVES: To examine whether physical therapy (PT) is cost-effective compared with arthroscopic partial meniscectomy (APM) in patients with a non-obstructive meniscal tear, we performed a full trial-based economic evaluation from a societal perspective. In a secondary analysis-this paper-we examined whether PT is non-inferior to APM. METHODS: We recruited patients aged 45-70 years with a non-obstructive meniscal tear in nine Dutch hospitals. Resource use was measured using web-based questionnaires. Measures of effectiveness included knee function using the International Knee Documentation Committee (IKDC) and quality-adjusted life-years (QALYs). Follow-up was 24 months. Uncertainty was assessed using bootstrapping techniques. The non-inferiority margins for societal costs, the IKDC and QALYs, were €670, 8 points and 0.057 points, respectively. RESULTS: We randomly assigned 321 patients to PT (n=162) or APM (n=159). PT was associated with significantly lower costs after 24 months compared with APM (-€1803; 95% CI -€3008 to -€838). The probability of PT being cost-effective compared with APM was 1.00 at a willingness to pay of €0/unit of effect for the IKDC (knee function) and QALYs (quality of life) and decreased with increasing values of willingness to pay. The probability that PT is non-inferior to APM was 0.97 for all non-inferiority margins for the IKDC and 0.89 for QALYs. CONCLUSIONS: The probability of PT being cost-effective compared with APM was relatively high at reasonable values of willingness to pay for the IKDC and QALYs. Also, PT had a relatively high probability of being non-inferior to APM for both outcomes. This warrants further deimplementation of APM in patients with non-obstructive meniscal tears. TRIAL REGISTRATION NUMBERS: NCT01850719 and NTR3908.

Effect of Early Surgery vs Physical Therapy on Knee Function Among Patients With Nonobstructive Meniscal Tears: The ESCAPE Randomized Clinical Trial.

Importance: Despite recent studies suggesting arthroscopic partial meniscectomy (APM) is not more effective than physical therapy (PT), the procedure is still frequently performed in patients with meniscal tears. Objective: To assess whether PT is noninferior to APM for improving patient-reported knee function in patients with meniscal tears. Design, Setting, and Participants: Noninferiority, multicenter, randomized clinical trial conducted in 9 hospitals in the Netherlands. Participants were aged 45 to 70 years with nonobstructive meniscal tears (ie, no locking of the knee joint). Patients with knee instability, severe osteoarthritis, and body mass index greater than 35 were excluded. Recruitment took place between July 17, 2013, and November 4, 2015. Participants were followed up for 24 months (final participant follow-up, October 11, 2017). Interventions: Three hundred twenty-one participants were randomly assigned to APM (n = 159) or a predefined PT protocol (n = 162). The PT protocol consisted of 16 sessions of exercise therapy over 8 weeks focused on coordination and closed kinetic chain strength exercises. Main Outcomes and Measures: The primary outcome was change in patient-reported knee function on the International Knee Documentation Committee Subjective Knee Form (range, 0 to 100; from worse to best) from baseline over a 24-month follow-up period. The noninferiority margin was defined as a difference between treatment groups of 8 points and was assessed with a 1-sided α of .025. The primary analysis followed the intention-to-treat principle. Results: Among 321 patients who were randomized (mean [SD] age, 58 [6.6] years; 161 women [50%]), 289 (90%) completed the trial (161 women and 158 men). In the PT group, 47 participants (29%) had APM during the 24-month follow-up period, and 8 participants randomized to APM (5%) did not have APM. Over a 24-month follow-up period, knee function improved in the APM group by 26.2 points (from 44.8 to 71.5) and in the PT group by 20.4 points (from 46.5 to 67.7). The overall between-group difference was 3.6 points (97.5% CI, -∞ to 6.5; P value for noninferiority = .001). Adverse events occurred in 18 participants in the APM group and 12 in the PT group. Repeat surgery (3 in the APM group and 1 in the PT group) and additional outpatient visits for knee pain (6 in the APM group and 2 in the PT group) were the most frequent adverse events. Conclusions and Relevance: Among patients with nonobstructive meniscal tears, PT was noninferior to APM for improving patient-reported knee function over a 24-month follow-up period. Based on these results, PT may be considered an alternative to surgery for patients with nonobstructive meniscal tears. Trial Registration: ClinicalTrials.gov Identifier: NCT01850719.

How to assess femoral and tibial component rotation after total knee arthroplasty with computed tomography: a systematic review.

PURPOSE: One of the most important factors leading to revision of total knee arthroplasties (TKA) is malrotation of femoral and/or tibial component. Rotation measurements performed on radiographs are limited and less reliable compared to 2D computed tomography (CT). Nowadays, 2D-CT and 3D-CT can be distinguished in measuring rotation of the TKA components. The aim of this systematic review is to determine the most reliable CT techniques in measuring rotation of the TKA components and to investigate possible cut-off points that can be used in the clinician's decision for a possible revision of the TKA. METHODS: A search of PubMed, Embase, the Cochrane Central Register of Controlled Trials and Web of Science was performed up to April 2015. Final selections of 12 articles were used in this systematic review. RESULTS: 3D-CT, compared to 2D-CT, is more reliable and shows a high level of intra- and interobserver reliability. Femoral component rotation is measured using the component's posterior condylar line or inner pegs in relation to the epicondylar axis. Five different techniques were used to measure tibial component rotation. The posterior border of the tibial component in relationship to the geometric centre and tibial tubercle was most frequently used. CONCLUSION: This systematic review shows a strong preference for 3D-CT to determine the component's rotation following a TKA. The literature shows consensus on the reference points of the femoral component. In measurements of the tibial component, various techniques are used with similar results. No clear cut-off point for revision of malrotated TKA components can be stated because of limited evidence. LEVEL OF EVIDENCE: III.

Cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy for traumatic meniscal tears in patients aged under 45 years.

Aims: The aim of this study was to evaluate the cost-effectiveness of arthroscopic partial meniscectomy versus physical therapy plus optional delayed arthroscopic partial meniscectomy in young patients aged under 45 years with traumatic meniscal tears. Methods: We conducted a multicentre, open-labelled, randomized controlled trial in patients aged 18 to 45 years, with a recent onset, traumatic, MRI-verified, isolated meniscal tear without knee osteoarthritis. Patients were randomized to arthroscopic partial meniscectomy or standardized physical therapy with an optional delayed arthroscopic partial meniscectomy after three months of follow-up. We performed a cost-utility analysis on the randomization groups to compare both treatments over a 24-month follow-up period. Cost utility was calculated as incremental costs per quality-adjusted life year (QALY) gained of arthroscopic partial meniscectomy compared to physical therapy. Calculations were performed from a healthcare system perspective and a societal perspective. Results: A total of 100 patients were included: 49 were randomized to arthroscopic partial meniscectomy and 51 to physical therapy. In the physical therapy group, 21 patients (41%) received delayed arthroscopic partial meniscectomy during follow-up. Over 24 months, patients in the arthroscopic partial meniscectomy group had a mean 0.005 QALYs lower quality of life (95% confidence interval -0.13 to 0.14). The cost-utility ratio was €-160,000/QALY from the healthcare perspective and €-223,372/QALY from the societal perspective, indicating that arthroscopic partial meniscectomy incurs additional costs without any added health benefit. Conclusion: Arthroscopic partial meniscectomy is arthroscopic partial meniscectomy is unlikely to be cost-effective in treating young patients with isolated traumatic meniscal tears compared to physical therapy as a primary health intervention. Arthroscopic partial meniscectomy leads to a similar quality of life, but higher costs, compared to physical therapy plus optional delayed arthroscopic partial meniscectomy.

Effect of Physical Therapy vs Arthroscopic Partial Meniscectomy in People With Degenerative Meniscal Tears: Five-Year Follow-up of the ESCAPE Randomized Clinical Trial.

Importance: There is a paucity of high-quality evidence about the long-term effects (ie, 3-5 years and beyond) of arthroscopic partial meniscectomy vs exercise-based physical therapy for patients with degenerative meniscal tears. Objectives: To compare the 5-year effectiveness of arthroscopic partial meniscectomy and exercise-based physical therapy on patient-reported knee function and progression of knee osteoarthritis in patients with a degenerative meniscal tear. Design, Setting, and Participants: A noninferiority, multicenter randomized clinical trial was conducted in the orthopedic departments of 9 hospitals in the Netherlands. A total of 321 patients aged 45 to 70 years with a degenerative meniscal tear participated. Data collection took place between July 12, 2013, and December 4, 2020. Interventions: Patients were randomly allocated to arthroscopic partial meniscectomy or 16 sessions of exercise-based physical therapy. Main Outcomes and Measures: The primary outcome was patient-reported knee function (International Knee Documentation Committee Subjective Knee Form (range, 0 [worst] to 100 [best]) during 5 years of follow-up based on the intention-to-treat principle, with a noninferiority threshold of 11 points. The secondary outcome was progression in knee osteoarthritis shown on radiographic images in both treatment groups. Results: Of 321 patients (mean [SD] age, 58 [6.6] years; 161 women [50.2%]), 278 patients (87.1%) completed the 5-year follow-up with a mean follow-up time of 61.8 months (range, 58.8-69.5 months). From baseline to 5-year follow-up, the mean (SD) improvement was 29.6 (18.7) points in the surgery group and 25.1 (17.8) points in the physical therapy group. The crude between-group difference was 3.5 points (95% CI, 0.7-6.3 points; P < .001 for noninferiority). The 95% CI did not exceed the noninferiority threshold of 11 points. Comparable rates of progression of radiographic-demonstrated knee osteoarthritis were noted between both treatments. Conclusions and Relevance: In this noninferiority randomized clinical trial after 5 years, exercise-based physical therapy remained noninferior to arthroscopic partial meniscectomy for patient-reported knee function. Physical therapy should therefore be the preferred treatment over surgery for degenerative meniscal tears. These results can assist in the development and updating of current guideline recommendations about treatment for patients with a degenerative meniscal tear. Trial Registration: ClinicalTrials.gov Identifier: NCT01850719.

Functional Outcomes of Arthroscopic Partial Meniscectomy Versus Physical Therapy for Degenerative Meniscal Tears Using a Patient-Specific Score: A Randomized Controlled Trial.

BACKGROUND: It is unknown whether the treatment effects of partial meniscectomy and physical therapy differ when focusing on activities most valued by patients with degenerative meniscal tears. PURPOSE: To compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients' most important functional limitations as the outcome. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: This study is part of the Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE) trial, a multicenter noninferiority randomized controlled trial conducted in 9 orthopaedic hospital departments in the Netherlands. The ESCAPE trial included 321 patients aged between 45 and 70 years with a symptomatic, magnetic resonance imaging-confirmed meniscal tear. Exclusion criteria were severe osteoarthritis, body mass index >35 kg/m2, locking of the knee, and prior knee surgery or knee instability due to an anterior or posterior cruciate ligament rupture. This study compared partial meniscectomy with physical therapy consisting of a supervised incremental exercise protocol of 16 sessions over 8 weeks. The main outcome measure was the Dutch-language equivalent of the Patient-Specific Functional Scale (PSFS), a secondary outcome measure of the ESCAPE trial. We used crude and adjusted linear mixed-model analyses to reveal the between-group differences over 24 months. We calculated the minimal important change for the PSFS using an anchor-based method. RESULTS: After 24 months, 286 patients completed the follow-up. The partial meniscectomy group (n = 139) improved on the PSFS by a mean of 4.8 ± 2.6 points (from 6.8 ± 1.9 to 2.0 ± 2.2), and the physical therapy group (n = 147) improved by a mean of 4.0 ± 3.1 points (from 6.7 ± 2.0 to 2.7 ± 2.5). The crude overall between-group difference showed a -0.6-point difference (95% CI, -1.0 to -0.2; P = .004) in favor of the partial meniscectomy group. This improvement was statistically significant but not clinically meaningful, as the calculated minimal important change was 2.5 points on an 11-point scale. CONCLUSION: Both interventions were associated with a clinically meaningful improvement regarding patients' most important functional limitations. Although partial meniscectomy was associated with a statistically larger improvement at some follow-up time points, the difference compared with physical therapy was small and clinically not meaningful at any follow-up time point. REGISTRATION: NCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).

Responsiveness and Minimal Important Change of the IKDC of Middle-Aged and Older Patients With a Meniscal Tear.

BACKGROUND: Responsiveness and the minimal important change (MIC) are important measurement properties to evaluate treatment effects and to interpret clinical trial results. The International Knee Documentation Committee (IKDC) Subjective Knee Form is a reliable and valid instrument for measuring patient-reported knee-specific symptoms, functioning, and sports activities in a population with meniscal tears. However, evidence on responsiveness is of limited methodological quality, and the MIC has not yet been established for patients with symptomatic meniscal tears. PURPOSE: To evaluate the responsiveness and determine the MIC of the IKDC for patients with meniscal tears. STUDY DESIGN: Cohort study (design); Level of evidence 2. METHODS: This study was part of the ESCAPE trial: a noninferiority multicenter randomized controlled trial comparing arthroscopic partial meniscectomy with physical therapy. Patients aged 45 to 70 years who were treated for a meniscal tear by arthroscopic partial meniscectomy or physical therapy completed the IKDC and 3 other questionnaires (RAND 36-Item Health Survey, EuroQol-5D-5L, and visual analog scales for pain) at baseline and 6-month follow-up. Responsiveness was evaluated by testing predefined hypotheses about the relation of the change in IKDC with regard to the change in the other self-reported outcomes. An external anchor question was used to distinguish patients reporting improvement versus no change in daily functioning. The MIC was determined by the optimal cutoff point in the receiver operating characteristic curve, which quantifies the IKDC score that best discriminated between patients with and without improvement in daily function. RESULTS: Data from all 298 patients who completed baseline and 6-month follow-up questionnaires were analyzed. Responsiveness of the IKDC was confirmed in 7 of 10 predefined hypotheses about the change in IKDC score with regard to other patient-reported outcome measures. One hypothesis differed in the expected direction, while 2 hypotheses failed to meet the expected magnitude by 0.02 and 0.01 points. An MIC of 10.9 points was calculated for the IKDC of middle-aged and older patients with meniscal tears. CONCLUSION: This study showed that the IKDC is responsive to change among patients aged 45 to 70 years with meniscal tears, with an MIC of 10.9 points. This strengthens the value of the IKDC in quantifying treatment effects in this population.

Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45†years with non-obstructive meniscal tears (ESCAPE study): protocol of a randomised controlled trial.

INTRODUCTION: Recent studies show similar outcome between surgery and conservative treatment in patients with non-obstructive meniscal tears. However, surgery is still often preferred over conservative treatment. When conservative treatment is non-inferior to surgery, shifting the current standard treatment choice to conservative treatment alone could save over €30 millions of direct medical costs on an annual basis. Economic evaluation studies comparing surgery to conservative treatment are lacking. METHODS AND ANALYSIS: A multicentre randomised controlled trial (RCT) with an economic evaluation alongside was performed to assess the (cost)-effectiveness of surgery and conservative treatment for meniscal tears. We will include 402 participants between 45 and 70 years with an MRI-confirmed symptomatic, non-obstructive meniscal tears to prove non-inferiority of conservative treatment. Block randomisation will be web-based. The primary outcome measure is a physical function, measured by the International Knee Documentation Committee 'Subjective Knee Form'. Furthermore, we will perform a cost-effectiveness and cost-utility analysis from societal perspective and a budget impact analysis from a societal, government and insurer perspective. Secondary outcomes include general health, quality of life, activity level, knee pain, physical examination, progression of osteoarthritis and the occurrence of adverse events. ETHICS AND DISSEMINATION: This RCT will be performed in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee (number NL44188.100.13). The results of this study will be reported in peer-reviewed journals and at international conferences. We further aim to disseminate our results to guideline committees. TRIAL REGISTRATION NUMBER: NCT01850719.