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Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design.

ABSTRACT: Arthroscopic partial meniscectomy (APM) to treat degenerative meniscus injury is the most common orthopaedic procedure. However, valid evidence of the efficacy of APM is lacking. Controlling for the placebo effect of any medical intervention is important, but seems particularly pertinent for the assessment of APM, as the symptoms commonly attributed to a degenerative meniscal injury (medial joint line symptoms and perceived disability) are subjective and display considerable fluctuation, and accordingly difficult to gauge objectively.A multicentre, parallel randomised, placebo surgery controlled trial is being carried out to assess the efficacy of APM for patients from 35 to 65 years of age with a degenerative meniscus injury. Patients with degenerative medial meniscus tear and medial joint line symptoms, without clinical or radiographic osteoarthritis of the index knee, were enrolled and then randomly assigned (1?:?1) to either APM or diagnostic arthroscopy (placebo surgery). Patients are followed up for 12 months. According to the prior power calculation, 140 patients were randomised. The two randomised patient groups will be compared at 12 months with intention-to-treat analysis. To safeguard against bias, patients, healthcare providers, data collectors, data analysts, outcome adjudicators and the researchers interpreting the findings will be blind to the patients' interventions (APM/placebo). Primary outcomes are Lysholm knee score (a generic knee instrument), knee pain (using a numerical rating scale), and WOMET score (a disease-specific, health-related quality of life index). The secondary outcome is 15D (a generic quality of life instrument). Further, in one of the five centres recruiting patients for the randomised controlled trial (RCT), all patients scheduled for knee arthroscopy due to a degenerative meniscus injury are prospectively followed up using the same protocol as in the RCT to provide an external validation cohort. In this article, we present and discuss our study design, focusing particularly on the internal and external validity of our trial and the ethics of carrying out a placebo surgery controlled trial.The protocol has been approved by the institutional review board of the Pirkanmaa Hospital District and the trial has been duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.ClinicalTrials.gov, number NCT00549172.

SUBMITTER: Sihvonen R

PROVIDER: S-EPMC3612785 | biostudies-literature | 2013 Mar

REPOSITORIES: biostudies-literature

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Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design.

Sihvonen Raine R Paavola Mika M Malmivaara Antti A Järvinen Teppo L N TL

BMJ open 20130309 3

<h4>Introduction</h4>Arthroscopic partial meniscectomy (APM) to treat degenerative meniscus injury is the most common orthopaedic procedure. However, valid evidence of the efficacy of APM is lacking. Controlling for the placebo effect of any medical intervention is important, but seems particularly pertinent for the assessment of APM, as the symptoms commonly attributed to a degenerative meniscal injury (medial joint line symptoms and perceived disability) are subjective and display considerable ...[more]

PMID: 23474796

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Project description:OBJECTIVES:To assess the long-term effects of arthroscopic partial meniscectomy (APM) on the development of radiographic knee osteoarthritis, and on knee symptoms and function, at 5 years follow-up. DESIGN:Multicentre, randomised, participant- and outcome assessor-blinded, placebo-surgery controlled trial. SETTING:Orthopaedic departments in five public hospitals in Finland. PARTICIPANTS:146 adults, mean age 52 years (range 35-65 years), with knee symptoms consistent with degenerative medial meniscus tear verified by MRI scan and arthroscopically, and no clinical signs of knee osteoarthritis were randomised. INTERVENTIONS:APM or placebo surgery (diagnostic knee arthroscopy). MAIN OUTCOME MEASURES:We used two indices of radiographic knee osteoarthritis (increase in Kellgren and Lawrence grade ?1, and increase in Osteoarthritis Research Society International (OARSI) atlas radiographic joint space narrowing and osteophyte sum score, respectively), and three validated patient-relevant measures of knee symptoms and function (Western Ontario Meniscal Evaluation Tool (WOMET), Lysholm, and knee pain after exercise using a numerical rating scale). RESULTS:There was a consistent, slightly greater risk for progression of radiographic knee osteoarthritis in the APM group as compared with the placebo surgery group (adjusted absolute risk difference in increase in Kellgren-Lawrence grade ?1 of 13%, 95% CI -2% to 28%; adjusted absolute mean difference in OARSI sum score 0.7, 95% CI 0.1 to 1.3). There were no relevant between-group differences in the three patient-reported outcomes: adjusted absolute mean differences (APM vs placebo surgery), -1.7 (95% CI -7.7 to 4.3) in WOMET, -2.1 (95% CI -6.8 to 2.6) in Lysholm knee score, and -0.04 (95% CI -0.81 to 0.72) in knee pain after exercise, respectively. The corresponding adjusted absolute risk difference in the presence of mechanical symptoms was 18% (95% CI 5% to 31%); there were more symptoms reported in the APM group. All other secondary outcomes comparisons were similar. CONCLUSIONS:APM was associated with a slightly increased risk of developing radiographic knee osteoarthritis and no concomitant benefit in patient-relevant outcomes, at 5 years after surgery. TRIAL REGISTRATION:ClinicalTrials.gov (NCT01052233 and NCT00549172).

Project description:ObjectiveWe examined the cost-effectiveness of treatment strategies for concomitant meniscal tear and knee osteoarthritis (OA) involving arthroscopic partial meniscectomy surgery and physical therapy (PT).MethodsWe used the Osteoarthritis Policy Model, a validated Monte Carlo microsimulation, to compare three strategies, 1) PT-only, 2) immediate surgery, and 3) PT + optional surgery, for participants whose pain persists following initial PT. We modeled a cohort with baseline meniscal tear, OA, and demographics from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial of arthroscopic partial meniscectomy versus PT. We estimated risks and costs of arthroscopic partial meniscectomy complications and accounted for heightened OA progression post surgery using published data. We estimated surgery use rates and treatment efficacies using MeTeOR data. We considered a 5-year time horizon, discounted costs, and quality-adjusted life-years (QALYs) 3% per year and conducted sensitivity analyses. We report incremental cost-effectiveness ratios.ResultsRelative to PT-only, PT + optional surgery added 0.0651 QALY and $2,010 over 5 years (incremental cost-effectiveness ratio = $30,900 per QALY). Relative to PT + optional surgery, immediate surgery added 0.0065 QALY and $3080 (incremental cost-effectiveness ratio = $473,800 per QALY). Incremental cost-effectiveness ratios were sensitive to optional surgery efficacy in the PT + optional surgery strategy. In the probabilistic sensitivity analysis, PT + optional surgery was cost-effective in 51% of simulations at willingness-to-pay thresholds of both $50,000 per QALY and $100,000 per QALY.ConclusionFirst-line arthroscopic partial meniscectomy has a prohibitively high incremental cost-effectiveness ratio. Under base case assumptions, second-line arthroscopic partial meniscectomy offered to participants with persistent pain following initial PT is cost-effective at willingness-to-pay thresholds between $31,000 and $473,000 per QALY. Our analyses suggest that arthroscopic partial meniscectomy can be a high-value treatment option for patients with meniscal tear and OA when performed following an initial PT course and should remain a covered treatment option.

Project description:Objectives To compare patient reported outcomes from before surgery to 52 weeks after surgery between individuals undergoing arthroscopic partial meniscectomy for traumatic meniscal tears and those for degenerative meniscal tears.Design Comparative prospective cohort study.Setting Four public orthopaedic departments in the Region of Southern Denmark. Participants were recruited between 1 February 2013 and 31 January 2014, and at one of the original four hospitals from 1 February 2014 to 31 January 2015.Participants Individuals selected from Knee Arthroscopy Cohort Southern Denmark, aged 18-55, and undergoing arthroscopic partial meniscectomy for a traumatic or degenerative meniscal tear (defined by a combination of age and symptom onset).Interventions Both participant groups underwent arthroscopic partial meniscectomy for a meniscal tear, with operating surgeons recording relevant information on knee pathology. Patient reported outcomes were recorded via online questionnaires.Main outcome measures Primary outcome was the average between-group difference in change on four of five subscales of the knee injury and osteoarthritis outcome score (KOOS). The four subscales covered pain, symptoms, sport and recreational function, and quality of life (KOOS4). A 95% confidence interval excluding differences greater than 10 KOOS points between groups was interpreted as absence of a clinically meaningful difference. Analyses adjusted for age, sex, and body mass index.Results 397 eligible adults (42% women) with a traumatic or degenerative meniscal tear (n=141, mean age 38.7 years (standard deviation 10.9); n=256, 46.6 years (6.4); respectively) were included in the main analysis. At 52 weeks after arthroscopic partial meniscectomy, 55 (14%) patients were lost to follow-up. Statistically, participants with degenerative meniscal tears had a significantly larger improvement in KOOS4 scores than those with traumatic tears (adjusted between-group difference -5.1 (95% confidence interval -8.9 to -1.3); P=0.008). In the analysis including KOOS4 score at all time points, a significant time-by-group interaction was observed in both the unadjusted (P=0.025) and adjusted analysis (P=0.024), indicating better self-reported outcomes in participants with degenerative tears. However, the difference between groups was at no time point considered clinically meaningful.Conclusions These results question the current tenet that patients with traumatic meniscal tears experience greater improvements in patient reported outcomes after arthroscopic partial meniscectomy than patients with degenerative tears.Trial registration ClinicalTrials.gov identifier NCT01871272.

Project description:OBJECTIVE:To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. METHODS:In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. RESULTS:In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. CONCLUSIONS:In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.

Project description:Background: Meniscus tears are the most common injury in the knee and are associated with an increased risk of osteoarthritis (OA). The molecular profile of knees with meniscus tears is not well-studied. Therefore, to advance our understanding of the early response of the knee to injury, we compared the gene expression profile of meniscus and articular cartilage within the same knees following meniscus injury. Hypothesis/Purpose: To identify differences between the molecular signatures of meniscus and articular cartilage from knees with intact articular cartilage undergoing arthroscopic partial meniscectomy. Study Design: Descriptive laboratory study Methods: Patients (n=12) with a known isolated medial meniscus tear without any knee chondrosis or radiographic OA were consented prior to surgery. During arthroscopic partial meniscectomy, a sample of their injured meniscus and a sample of their articular cartilage off the medial femoral condyle were procured. The transcriptome signatures, as measured through Affymetrix microarray, were compared between the two tissues and underlying biological processes were explored computationally. Results: 3566 gene transcripts were differentially expressed between meniscus and articular cartilage. Gene transcripts down-regulated in articular cartilage were associated with extracellular matrix organization, wound healing, cell adhesion, and chemotaxis. Gene transcripts up-regulated in articular cartilage were associated with blood vessels morphogenesis and angiogenesis. Examples of individual genes with significant differences in expression between the two tissues include IBSP (23.76 fold; P < 0.001), upregulated in meniscus, and TREM1 (3.23 fold; P = 0.006), upregulated in meniscus. Conclusion: The meniscus and articular cartilage have distinct gene expression profiles in knees with meniscus tears and intact articular cartilage. Total RNA obtained from injured meniscus and normal articular cartilage from patients undergoing partial meniscectomy.

Project description:BackgroundIt 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.PurposeTo compare partial meniscectomy with physical therapy in patients with a degenerative meniscal tear, focusing on patients' most important functional limitations as the outcome.Study designRandomized controlled trial; Level of evidence, 1.MethodsThis 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.ResultsAfter 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.ConclusionBoth 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.RegistrationNCT01850719 (ClinicalTrials.gov identifier) and NTR3908 (the Netherlands Trial Register).

Project description:Objective To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears.Design Randomised controlled superiority trial.Setting Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway.Participants 140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis.Interventions 12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone.Main outcome measures Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months.Results No clinically relevant difference was found between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval -4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit.Conclusion The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.Trial registration www.clinicaltrials.gov (NCT01002794).

Project description:ObjectiveTo determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears.DesignRandomised controlled superiority trial.SettingOrthopaedic departments at two public hospitals and two physiotherapy clinics in Norway.Participants140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis.Interventions12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone.Main outcome measuresIntention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months.ResultsNo clinically relevant difference was found between the two groups in change in KOOS4 at two years (0.9 points, 95% confidence interval -4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit.ConclusionThe observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.Trial registrationwww.clinicaltrials.gov (NCT01002794).

Dataset Information

Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design.

Publications

Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design.

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