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Outcomes The primary outcome was the difference between the study groups with respect to the change in the score on the physical-function scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) 14 from baseline to 6 months after randomization. The concordance between these readings was 71. Figure 2 Scores on the WOMAC Physical-Function Scale and KOOS Pain Scale over the 12-Month Follow-up Period. Adobe Flash Player is required to view this feature. Clinicians who suspect that the tear is symptomatic may refer the patient to a surgeon for arthroscopic partial meniscectomy. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Methods We conducted a multicenter, randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and evidence of mild-to-moderate osteoarthritis on imaging. ClinicalTrials. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Interventions Teams of surgeon investigators met in person on two occasions and regularly by telephone conference call throughout enrollment, as did teams of physical therapists. Methods Study Design and Oversight This randomized, controlled trial was conducted in seven U. Surgeons removed loose fragments of cartilage and bone, but this procedure did not involve penetration of the subchondral bone. The primary analysis used a modified intention-to-treat approach in which patients who did not withdraw from the study were evaluated in the group to which they were randomly assigned. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. ClinicalTrials. Third, we did not formally assess the fidelity of the physical therapists or surgeons to the standard intervention protocols. The original statistical-analysis plan referred to the primary outcome as the WOMAC function score at 6 months, with adjustment for the baseline score. Statistical Analysis The primary analysis was implemented with an analysis of covariance with changes in the WOMAC physical-function score from baseline to 6 months as the dependent variable, treatment as the independent variable of interest, and study site as a covariate. , Christine E. There was no commercial sponsorship of this trial. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Scores on both scales range from 0 to 100, with higher KOOS scores indicating more severe pain and higher SF-36 scores indicating greater physical activity. Patients were then randomly assigned in a 1:1 ratio to a treatment group with the use of a secure program on the trial website. A total of 67% of patients assigned to arthroscopic partial meniscectomy met this threshold for success, as compared with 44% of patients treated with physical therapy alone. Standardization was developed further in telephone conference calls and meetings with the use of case examples. Adobe Flash Player is required to view this feature. The most frequent reason that patients declined enrollment was a strong preference for one treatment or the other. At each stage, it was recommended that the patient attend physical-therapy sessions once or twice weekly and perform exercises at home. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The results at 12 months were similar to those at 6 months. Adobe Flash Player is required to view this feature. The asterisk indicates that nine patients assigned to APM did not undergo surgery. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The proportion of patients who crossed over from physical therapy to arthroscopic partial meniscectomy ranged from 0. Surgeons, patients, and research staff were aware of the treatment assignments. Details of the physical-therapy program are described in Table 2 in the Supplementary Appendix. APM denotes arthroscopic partial meniscectomy, MRI magnetic resonance imaging, PT physical therapy, and TKR total knee replacement. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Among 330 active participants in the study, by 6 months of follow-up, 51 patients assigned to physical therapy alone (30. An additional 8 active patients in the study (4. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. 5% across study centers. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. These results were achieved with a 30% rate of crossover to arthroscopic partial meniscectomy at 6 months. Physical Therapy The physical-therapy protocol was developed by a team of experienced physical therapists. 2%) had undergone arthroscopic partial meniscectomy, whereas 9 patients assigned to surgery (5. We required that patients have at least one symptom that was consistent with a meniscal tear 11 that had persisted for at least 1 month despite pharmacologic treatment, physical therapy, or limitation of activity. We added a 12-month assessment to determine whether the response was stable. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. Given the frequency and cost of arthroscopic partial meniscectomy and the paucity of data, we designed the Meniscal Tear in Osteoarthritis Research (METEOR) trial to assess the efficacy of arthroscopic partial meniscectomy as compared with a standardized physical-therapy regimen for symptomatic patients with a meniscal tear and concomitant mild-to-moderate osteoarthritis. Adobe Flash Player is required to view this feature. These teams developed standardized surgical and physical-therapy interventions that were implemented in all study centers. Secondary outcomes were the pain score on the Knee Injury and Osteoarthritis Outcome Scale (KOOS), which has been used frequently in studies involving patients with a meniscal tear, 15,16 and the score on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). Readings performed at the clinical site were used for assessing eligibility and randomization strata, whereas central readings were used in the analysis. Adverse Events There were no significant between-group differences in the frequencies of overall or specific adverse events. Adobe Flash Player is required to view this feature. Criteria for advancing from stage I to II and from stage II to III included the level of self-reported pain, observed strength, range of knee motion, knee effusion, and functional mobility. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The role of arthroscopic surgery in patients with osteoarthritis has been studied in two randomized, controlled trials over the past decade. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. In both the arthroscopic-partial-meniscectomy and physical-therapy groups, patients were permitted to receive acetaminophen and nonsteroidal antiinflammatory agents as needed. Since osteoarthritis-defining features can be seen on MRI before changes consistent with osteoarthritis can be detected on radiography, patients with normal findings on radiography and cartilage defects on MRI were eligible. Our findings suggest that both arthroscopic partial meniscectomy and referral to physical therapy — with an opportunity to consider arthroscopic partial meniscectomy if substantial improvements are not achieved — are likely to result in considerable improvement in functional status and knee pain over a 6-to-12-month period. S. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. A service of the U. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Postoperatively, patients were allowed to bear weight as they were able. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The primary outcome was the difference between the groups with respect to the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) 6 months after randomization. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. Treatment was generally scheduled within 2 to 4 weeks after randomization. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Details of the trial design and conduct have been published elsewhere. 10 The study was approved by the Partners HealthCare Human Research Committee and overseen by a data and safety monitoring board assembled by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats.
17 We also considered a binary outcome that was defined as improvement in the WOMAC physical-function score of at least 8 points (a clinically relevant difference specified a priori 10,18,19 ) without crossover to the other study group. gov currently lists 235,782 studies with locations in all 50 States and in 195 countries. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. The frequency of adverse events did not differ significantly between the groups. Results Characteristics of the Study Population From June 2008 through August 2011, a total of 14,430 patients were screened in seven study centers, of whom 1330 (9. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. The primary outcome was assessed at 6 months, with the 3-month and 12-month assessments used to capture the trajectory and stability of the treatment response. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Intraarticular injections of glucocorticoids were permitted over the course of the trial. However, since the change in the WOMAC physical-function score is a standard outcome in assessing interventions for knee osteoarthritis and is more easily interpreted than the raw score at 6 months adjusted for the baseline score, we revised the primary outcome before analyzing the trial data. We performed three secondary analyses: an analogous intention-to-treat analysis of covariance with the use of either the KOOS pain score or the SF-36 physical-activity score as the dependent variables and a logistic regression, with adjustment for the study site, which used the binary outcome defined above. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. tertiary referral centers. Patients were referred to a physical therapist for a postoperative standardized physical-therapy program with the use of the same protocol as that used in the physical-therapy group, described below. Panel C shows WOMAC physical-function scores in the APM group and in the PT group according to crossover status. Brophy, M. 8%. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Arthroscopic Partial Meniscectomy The protocol called for surgeons to perform an arthroscopic partial meniscectomy by trimming the damaged meniscus back to a stable rim. WOMAC scores range from 0 to 100, with higher scores indicating worse physical function. We specified 6 months as the time for assessment of the primary outcome because the clinical response to treatment is apparent by this time. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. All surgeons were fellowship-trained and performed at least 50 arthroscopic partial meniscectomies annually. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Analyses performed with readings at the clinical site did not materially differ from those performed with central readings. Adobe Flash Player is required to view this feature. D. Katz, M. 0 to 59. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. org. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. 4%) were enrolled and randomly assigned to a treatment group ( Figure 1 Figure 1 Trial Enrollment and Follow-up. The patients were evaluated at 6 and 12 months. APM denotes arthroscopic partial meniscectomy, MRI magnetic resonance imaging, PT physical therapy, and TKR total knee replacement. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Detailed entry and exclusion criteria (including specific symptoms that were consistent with a meniscal tear) are provided in Table 1 in the Supplementary Appendix, available at NEJM. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. Site coordinators contacted the participants by telephone every other week for the first 3 months after randomization and quarterly thereafter to ascertain adverse events and compliance with physical therapy. In general, the patients assigned to receive physical therapy alone who crossed over to surgery did not have substantial improvement in functional status during the period from randomization until the time of crossover ( Figure 2C ). Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. 6%) had not undergone the procedure. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. First, because we enrolled only 26% of eligible patients, our findings must be generalized cautiously. Adobe Flash Player is required to view this feature. The surgeon assessed eligibility criteria and referred eligible patients to the research coordinator, who introduced the study using a standardized script. Research coordinators at each center reviewed outpatient schedules to identify patients who were potentially eligible to participate in the study. 2%) were eligible. At 12 months, among 169 participants (not all of whom provided data at the 1-year evaluation), the rate of crossover to surgery was 35%. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Finally, our study was not blinded, since our investigative group did not consider a sham comparison group feasible. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Patients who wished to participate provided written informed consent and completed a baseline questionnaire. A Correction Has Been Published Original Article Surgery versus Physical Therapy for a Meniscal Tear and Osteoarthritis Jeffrey N. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. Of these patients, 351 (26. Adobe Flash Player is required to view this feature. Surgeons and coordinators told patients randomly assigned to physical therapy alone that they would have the opportunity to cross over to arthroscopic partial meniscectomy over time if the patient and surgeon thought it was clinically indicated. We randomly assigned 351 patients to surgery and postoperative physical therapy or to a standardized physical-therapy regimen (with the option to cross over to surgery at the discretion of the patient and surgeon). Adobe Flash Player is required to view this feature. Adobe Flash Player is required to view this feature. If you are using an operating system that does not support Flash, we are working to bring you alternative formats. These limitations notwithstanding, the results of our trial may help guide management in the care of patients with knee symptoms, a meniscal tear, and imaging evidence of osteoarthritis. , Robert H. Abstract Background Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain. 7%) who were assigned to the physical-therapy group crossed over to arthroscopic partial meniscectomy between 6 and 12 months. Adobe Flash Player is required to view this feature. We acknowledge, however, that because the treatment assignments were not blinded, and because crossover could not occur in the arthroscopic-partial-meniscectomy group once the surgery had been performed, this secondary analysis was vulnerable to bias. Adobe Flash Player is required to view this feature. S. Media in This Article Figure 1 Trial Enrollment and Follow-up. National Institutes of Health. D. The asterisk indicates that nine patients assigned to APM did not undergo surgery. Adobe Flash Player is required to view this feature. Assessments Questionnaires were administered at baseline and 3, 6, and 12 months after randomization. In intention-to-treat analyses of 12-month outcomes adjusted for study site, the two groups had similar changes from baseline in the WOMAC physical-function and KOOS pain scores ( Table 2 ). Panel C shows WOMAC physical-function scores in the APM group and in the PT group according to crossover status.
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