The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.
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SUBMITTER: Katz JN
PROVIDER: S-EPMC3468667 | biostudies-literature | 2012 Nov
REPOSITORIES: biostudies-literature
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The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.
Katz Jeffrey N JN Chaisson Christine E CE Cole Brian B Guermazi Ali A Hunter David J DJ Jones Morgan M Levy Bruce A BA Mandl Lisa A LA Martin Scott S Marx Robert G RG Safran-Norton Clare C Roemer Frank W FW Skoniecki Debra D Solomon Daniel H DH Spindler Kurt P KP Wright John J Wright Rick W RW Losina Elena E
Contemporary clinical trials 20120905 6
This paper presents the rationale and design features of the MeTeOR Trial (Meniscal Tear in Osteoarthritis Research; Clinical Trials.gov NCT00597012). MeTeOR is an NIH-funded seven-center prospective randomized controlled trial (RCT) designed to establish the efficacy of arthroscopic partial meniscectomy combined with a standardized physical therapy program as compared with a standardized physical therapy program alone in patients with a symptomatic meniscal tear in the setting of mild to modera ...[more]
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Project description:BackgroundMeniscal tears often accompany knee osteoarthritis, a disabling condition affecting 14 million individuals in the United States. While several randomized controlled trials have compared physical therapy to surgery for individuals with knee pain, meniscal tear, and osteoarthritic changes (determined via radiographs or magnetic resonance imaging), no trial has evaluated the efficacy of physical therapy alone in these subjects.MethodsThe Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial is a four-arm multi-center randomized controlled clinical trial designed to establish the comparative efficacy of two in-clinic physical therapy interventions (one focused on strengthening and one containing placebo) and two protocolized home exercise programs.DiscussionThe goal of this paper is to present the rationale behind TeMPO and describe the study design and implementation strategies, focusing on methodologic and clinical challenges.Trial registrationThe TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.
| S-EPMC6271417 | biostudies-literature
Project description:BackgroundWhether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain.MethodsWe 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. 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). The patients were evaluated at 6 and 12 months. 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.ResultsIn the intention-to-treat analysis, the mean improvement in the WOMAC score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5). At 6 months, 51 active participants in the study who were assigned to physical therapy alone (30%) had undergone surgery, and 9 patients assigned to surgery (6%) had not undergone surgery. The results at 12 months were similar to those at 6 months. The frequency of adverse events did not differ significantly between the groups.ConclusionsIn the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; METEOR ClinicalTrials.gov number, NCT00597012.).
| S-EPMC3690119 | biostudies-literature
Project description:To identify predictors of poor exercise adherence in patients with osteoarthritis (OA) and meniscal tear.Secondary analysis of data gathered over the first 12 weeks in the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial, a multicenter, randomized controlled trial.Seven referral centers.Most of the patients in the MeTeOR trial (N=325 of 351) were included in the analysis, each of whom was aged ?45 years and had a meniscal tear and osteoarthritic changes on imaging studies; 26 were excluded because of missing data from which to derive the primary outcome variable.All patients received a structured, supervised exercise program focused on strengthening, along with prescribed home exercises; half were randomly assigned to also receive arthroscopic partial meniscectomy.Poor exercise adherence through 12 weeks, defined as performing <50% of prescribed exercise.Thirty-eight percent of the MeTeOR cohort showed poor exercise adherence. In the multivariate model, adjusting for treatment group, those who earned ?$29,000 per year had 1.64 times the risk of nonadherence (95% confidence interval [CI], 1.10-2.43) than those who earned >$100,000 per year; and those without baseline pain with pivoting and twisting had 1.60 times greater risk of nonadherence than those with these symptoms (95% CI, 1.14-2.25).Low income was associated with poor exercise adherence among patients aged ?45 years with OA and a meniscal tear, as was absence of pain with pivoting and twisting. Our findings highlight the need for further research into exercise adherence and for interventions to enhance adherence among those with low incomes.
| S-EPMC5083166 | biostudies-literature
Project description:Meniscal tears and osteoarthritis (OA) frequently coexist, but to our knowledge, no data exist to identify who will benefit from arthroscopic partial meniscectomy (APM) versus nonoperative management. Our objective was to evaluate the capability of preoperative information to predict APM outcomes in OA.Using a mathematical model and published data, we combined 2 clinical (mechanical symptoms and pain pattern) and 2 magnetic resonance imaging (tear type and bone marrow lesions) indicators into 36 possible combinations and ranked each combination according to the likelihood of having primarily tear- versus OA-related pain in individuals ages 45-65 years with knee pain, OA, and meniscal tears. By considering alternative thresholds for performing APM, we identified the cutoff rank that maximized the overall population International Knee Documentation Committee (IKDC) score (0-100 scale).Rank 1 (e.g., displaced tear, locking, increased pain, no bone marrow lesions) represented the highest likelihood of APM benefit; rank 36 (e.g., oblique tear, no mechanical symptoms, static pain, severe bone marrow lesions) represented the lowest likelihood of APM benefit. Indeterminate middle ranks included individuals with mixed findings (i.e., 2 findings consistent with high and 2 with low likelihood of APM benefit). APM thresholds between ranks 17 and 23 resulted in >82% of the population receiving treatment producing the greatest possible IKDC improvement, with mean incremental gains in IKDC score of >24 points. Findings were robust across a broad range of indicator assumptions, but were sensitive to outcome assumptions.Among individuals with degenerative meniscal tears and OA, easily obtainable clinical information can differentiate those who are more likely to benefit from APM.
| S-EPMC2804854 | biostudies-literature
Project description:BackgroundArthroscopic partial meniscectomy (APM) is extensively used to relieve pain in patients with symptomatic meniscal tear (MT) and knee osteoarthritis (OA). Recent studies have failed to show the superiority of APM compared to other treatments. We aim to examine whether existing evidence is sufficient to reject use of APM as a cost-effective treatment for MT+OA.MethodsWe built a patient-level microsimulation using Monte Carlo methods and evaluated three strategies: Physical therapy ('PT') alone; PT followed by APM if subjects continued to experience pain ('Delayed APM'); and 'Immediate APM'. Our subject population was US adults with symptomatic MT and knee OA over a 10 year time horizon. We assessed treatment outcomes using societal costs, quality-adjusted life years (QALYs), and calculated incremental cost-effectiveness ratios (ICERs), incorporating productivity costs as a sensitivity analysis. We also conducted a value-of-information analysis using probabilistic sensitivity analyses.ResultsCalculated ICERs were estimated to be $12,900/QALY for Delayed APM as compared to PT and $103,200/QALY for Immediate APM as compared to Delayed APM. In sensitivity analyses, inclusion of time costs made Delayed APM cost-saving as compared to PT. Improving efficacy of Delayed APM led to higher incremental costs and lower incremental effectiveness of Immediate APM in comparison to Delayed APM. Probabilistic sensitivity analyses indicated that PT had 3.0% probability of being cost-effective at a willingness-to-pay (WTP) threshold of $50,000/QALY. Delayed APM was cost effective 57.7% of the time at WTP = $50,000/QALY and 50.2% at WTP = $100,000/QALY. The probability of Immediate APM being cost-effective did not exceed 50% unless WTP exceeded $103,000/QALY.ConclusionsWe conclude that current cost-effectiveness evidence does not support unqualified rejection of either Immediate or Delayed APM for the treatment of MT+OA. The amount to which society would be willing to pay for additional information on treatment outcomes greatly exceeds the cost of conducting another randomized controlled trial on APM.
| S-EPMC4472814 | biostudies-literature
Project description:ObjectivePatients with meniscal tears reporting meniscal symptoms such as catching or locking have traditionally undergone arthroscopy. The present study was undertaken to investigate whether patients with meniscal tears who report meniscal symptoms have greater improvement with arthroscopic partial meniscectomy (APM) than physical therapy (PT).MethodsWe used data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial, which randomized participants with knee osteoarthritis (OA) and meniscal tear to APM or PT. The frequency of each meniscal symptom (clicking, catching, popping, intermittent locking, giving way, swelling) was measured at baseline and 6 months. We used linear regression models to determine whether the difference in improvement in Knee Injury and Osteoarthritis Outcome Score (KOOS) pain score at 6 months between patients treated with APM versus PT was modified by the presence of each meniscal symptom. We also determined the percentage of participants with resolution of meniscal symptoms by treatment group.ResultsWe included 287 participants. The presence (versus absence) of any of the meniscal symptoms did not modify the improvement in KOOS pain score between APM versus PT by >0.5 SD (all P interaction >0.05). APM led to greater resolution of intermittent locking and clicking than PT (locking 70% versus 46%, clicking 41% versus 25%). No difference in resolution of the other meniscal symptoms was observed.ConclusionMeniscal symptoms were not associated with improved pain relief. Although symptoms of clicking and intermittent locking had a greater reduction in the APM group, the presence of meniscal symptoms in isolation should not inform clinical decisions surrounding APM versus PT in patients with meniscal tear and knee OA.
| S-EPMC8408275 | biostudies-literature
Project description:ObjectiveStrengthening-based physical therapy (PT) is frequently recommended for persons with knee osteoarthritis (OA) and meniscal tear. On average, knee OA patients experience pain improvement while undergoing PT, but whether these changes are accompanied by changes in muscle strength remains an important research question.DesignWe used data from subjects randomized to PT in the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. Key elements, measured at baseline and 3 months, included quadriceps and hamstrings strength (in pounds) and Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale (0-100; 100 worst). We examined the linear association between change in strength and change in pain over 3 months.Results111 subjects (mean age 57.1, average baseline hamstrings strength 27.5 (SD 14.7), average baseline KOOS 48.0 (SD 17.0)) experienced an average increase in hamstring strength of 3.5 lbs (SD 9.4) and an average decrease in KOOS Pain of 17.1 points (SD 17.4). The correlation between change in hamstrings strength and change in KOOS Pain was weak (Pearson r = 0.17; 95% CI-0.016-0.345). A multivariable linear regression model adjusting for baseline pain showed that a 10-pound increase in hamstrings strength was associated with a 2.9-point (95% CI-0.05-5.9) reduction in KOOS Pain. The association between changes in quadriceps strength and pain was even weaker than that for hamstrings pain.ConclusionWe observed small increases in strength and weak associations between strengthening and pain relief, suggesting that pain relief achieved during PT likely arises from multiple factors beyond strengthening alone.
| S-EPMC9718231 | biostudies-literature
Project description:The key to preventing early knee osteoarthritis is meniscal preservation. The main functions of the meniscus are impact absorption, mechanical load transmission, lubrication, joint stability, and proprioception. Radial lesions that extend to the joint capsule are called complete radial tears. This type of injury compromises 2 of the main meniscal functions, which are impact absorption and load distribution, which is equivalent, from a biomechanical perspective, to a total meniscectomy. In the recent past, the treatment of choice for this type of injury was partial meniscectomy. However, several studies have observed progressive joint degeneration after this type of treatment. Recently, different types of meniscal sutures involving radial lesions of the meniscus have been developed. It is believed that such repairs may bring a decrease in future osteoarthritis in this patient profile. The purpose of this article is to describe the steps of continuous meniscal suture for the treatment of radial tears of the medial and lateral menisci.
| S-EPMC8322627 | biostudies-literature
Project description:BACKGROUND:Arthroscopic partial meniscectomy (APM) combined with physical therapy (PT) have yielded pain relief similar to that provided by PT alone in randomized trials of subjects with a degenerative meniscal tear. However, many patients randomized to PT received APM before assessment of the primary outcome. We sought to identify factors associated with crossing over to APM and to compare pain relief between patients who had crossed over to APM and those who had been randomized to APM. METHODS:We used data from the MeTeOR (Meniscal Tear in Osteoarthritis Research) Trial of APM with PT versus PT alone in subjects ?45 years old who had mild-to-moderate osteoarthritis and a degenerative meniscal tear. We assessed independent predictors of crossover to APM among those randomized to PT. We also compared pain relief at 6 months among those randomized to PT who crossed over to APM, those who did not cross over, and those originally randomized to APM. RESULTS:One hundred and sixty-four subjects were randomized to and received APM and 177 were randomized to PT, of whom 48 (27%) crossed over to receive APM in the first 140 days after randomization. In multivariate analyses, factors associated with a higher likelihood of crossing over to APM among those who had originally been randomized to PT included a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score of ?40 (risk ratio [RR] = 1.99; 95% confidence interval [CI] = 1.00, 3.93) and symptom duration of <1 year (RR = 1.74; 95% CI = 0.98, 3.08). Eighty-one percent of subjects who crossed over to APM and 82% of those randomized to APM had an improvement of ?10 points in their pain score at 6 months, as did 73% of those who were randomized to and received only PT. CONCLUSIONS:Subjects who crossed over to APM had presented with a shorter symptom duration and greater baseline pain than those who did not cross over from PT. Subjects who crossed over had rates of surgical success similar to those of the patients who had been randomized to surgery. Our findings also suggest that an initial course of rigorous PT prior to APM may not compromise surgical outcome. LEVEL OF EVIDENCE:Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC5125163 | biostudies-literature
Project description:Background and purpose - No consensus exists on when to perform arthroscopic partial meniscectomy in patients with a degenerative meniscal tear. Since MRI and clinical tests are not accurate in detecting a symptomatic meniscal lesion, the patient's symptoms often play a large role when deciding when to perform surgery. We determined the prevalence and severity of self-reported knee symptoms in patients eligible for arthroscopic partial meniscectomy due to a degenerative meniscal tear. We investigated whether symptoms commonly considered to be related to meniscus injury were associated with early radiographic signs of knee osteoarthritis. Patients and methods - We included individual baseline items from the Knee injury and Osteoarthritis Outcome Score collected in 2 randomized controlled trials evaluating treatment for an MRI-verified degenerative medial meniscal tears in 199 patients aged 35-65 years. Each item was scored as no, mild, moderate, severe, extreme, and at least "mild" considering the symptoms present. Early radiographic signs of osteoarthritis, defined as a Kellgren and Lawrence grade of at least 1, were seen in 70 patients. Results - At least monthly knee pain, pain during stair walking and when twisting on the knee, and lack of confidence in knee was present in at least 80% of the patients. Median severity was at least moderate for knee pain, pain when twisting on the knee, pain walking on stairs, lack of confidence in knee, and clicking. Mechanical symptoms such as catching were rare. Early radiographic signs of osteoarthritis were associated with an increased risk of self-reported swelling, catching, and stiffness later in the day; the odds ratio was 2.4 (95% CI 1.2-4.9), 2.3 (1.2-4.3), and 2.3 (1.1-5.0), respectively. Interpretation - Middle-aged patients with a degenerative medial meniscus tear reported symptoms commonly associated with knee osteoarthritis. Frequent knee pain, presence of lack of confidence in the knee, and clicking did not distinguish those with a meniscal tear alone from those with early radiographic knee OA. Our findings support the notion that symptoms reported by those with a degenerative meniscal tear represent early signs of knee osteoarthritis.
| S-EPMC5694812 | biostudies-literature