Cost-Effectiveness of Arthroscopic Partial Meniscectomy and Physical Therapy for Degenerative Meniscal Tear.

OBJECTIVE: We examined the cost-effectiveness of treatment strategies for concomitant meniscal tear and knee osteoarthritis (OA) involving arthroscopic partial meniscectomy surgery and physical therapy (PT). METHODS: We 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. RESULTS: Relative 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. CONCLUSION: First-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.

Association Between Baseline Meniscal Symptoms and Outcomes of Operative and Nonoperative Treatment of Meniscal Tear in Patients With Osteoarthritis.

OBJECTIVE: Patients 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). METHODS: We 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. RESULTS: We 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. CONCLUSION: Meniscal 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.

Association between changes in muscle strength and pain in persons with meniscal tear and osteoarthritis.

Objective: Strengthening-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. Design: We 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. Results: 111 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. Conclusion: We 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.

A consensus-based process identifying physical therapy and exercise treatments for patients with degenerative meniscal tears and knee OA: the TeMPO physical therapy interventions and home exercise program.

BACKGROUND: Knee osteoarthritis (OA) is prevalent and often associated with meniscal tear. Physical therapy (PT) and exercise regimens are often used to treat OA or meniscal tear, but, to date, few programs have been designed specifically for conservative treatment of meniscal tear with concomitant knee OA. Clinical care and research would be enhanced by a standardized, evidence-based, conservative treatment program and the ability to study the effects of the contextual factors associated with interventions for patients with painful, degenerative meniscal tears in the setting of OA. This paper describes the process of developing both a PT intervention and a home exercise program for a randomized controlled clinical trial that will compare the effectiveness of these interventions for patients with knee pain, meniscal tear and concomitant OA. METHODS: This paper describes the process utilized by an interdisciplinary team of physical therapists, physicians, and researchers to develop and refine a standardized in-clinic PT intervention, and a standardized home exercise program to be carried out without PT supervision. The process was guided in part by Medical Research Council guidance on intervention development. RESULTS: The investigators achieved agreement on an in-clinic PT intervention that included manual therapy, stretching, strengthening, and neuromuscular functional training addressing major impairments in range of motion, musculotendinous length, muscle strength and neuromotor control in the major muscle groups associated with improving knee function. The investigators additionally achieved agreement on a progressive, protocol-based home exercise program (HEP) that addressed the same major muscle groups. The HEP was designed to allow patients to perform and progress the exercises without PT supervision, utilizing minimal equipment and a variety of methods for instruction. DISCUSSION: This multi-faceted in-clinic PT program and standardized HEP provide templates for in-clinic and home-based care for patients with symptomatic degenerative meniscal tear and concomitant OA. These interventions will be tested as part of the Treatment of Meniscal Tear in Osteoarthritis (TeMPO) Trial. TRIAL REGISTRATION: The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 on February 14, 2017. TeMPO was also approved by the Institutional Review Board at Partners HealthCare/Brigham and Women's Hospital.

Influence of Baseline Magnetic Resonance Imaging Features on Outcome of Arthroscopic Meniscectomy and Physical Therapy Treatment of Meniscal Tears in Osteoarthritis.

BACKGROUND: Arthroscopic partial meniscectomy (APM) is used to treat meniscal tears, although its efficacy is controversial. PURPOSE: This study used magnetic resonance imaging (MRI) to determine characteristics that lead to greater benefit from APM and physical therapy (PT) than from PT alone among patients with meniscal tear and knee osteoarthritis. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Using data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial, the authors first assessed whether the effect of treatment on pain scores at 6 months differed according to baseline MRI features (bone marrow lesions, cartilage and meniscal damage). Second, the authors summed MRI features associated with differential pain relief between APM and PT to create a "damage score," which included bone marrow lesion number and cartilage damage size with possible values of 0 (least damage), 1 (moderate), and 2 (greatest). The authors used linear models to determine whether the association between damage score and pain relief at 6 months differed for APM versus PT. RESULTS: The study included 220 participants: 13%, had the least damage; 52%, moderate; and 34%, greatest. Although treatment type did not significantly modify the association of damage score and change in pain ( P interaction = .13), those with the least damage and moderate damage had greater improvement with APM than with PT in Knee injury and Osteoarthritis Outcome Score pain subscale-by 15 and 7 points, respectively. Those with the greatest damage had a similar improvement with APM and PT. CONCLUSION: Among patients with osteoarthritis and meniscal tear, those with less intra-articular damage on MRI may have greater improvement in pain with APM and PT than with PT alone. However, these results should be interpreted cautiously owing to the limited sample size.

Relationship Between Patient-Reported Swelling and Magnetic Resonance Imaging-Defined Effusion-Synovitis in Patients With Meniscus Tears and Knee Osteoarthritis.

OBJECTIVE: Synovitis is a prevalent feature in patients with knee osteoarthritis (OA) and meniscal tear and is associated with pain and cartilage damage. Patient-reported swelling is also prevalent in this population. The aim of this study was to investigate the cross-sectional association between patient-reported swelling and effusion-synovitis detected by magnetic resonance imaging (MRI) in patients with OA and meniscal tear. METHODS: We used baseline data from a multicenter, randomized controlled trial, Meniscal Tear in Osteoarthritis Research (METEOR). MRI-identified effusion-synovitis, a proxy for effusion and synovitis on noncontrast MRIs, was graded as none/small versus medium/large. Using MRI-identified effusion-synovitis as the gold standard, we assessed the sensitivity, specificity, and positive predictive value of patient self-reported swelling in the previous week (none, intermittent, constant) to detect effusion and synovitis. RESULTS: We analyzed data from 276 patients. Twenty-five percent of patients reported no swelling, 40% had intermittent swelling, and 36% had constant swelling. Fifty-two percent had MRI-identified medium/large-grade effusion-synovitis. As compared with MRI-identified effusion-synovitis, any patient-reported swelling (versus none) had a sensitivity of 84% (95% confidence interval [95% CI] 77-89), a specificity of 34% (95% CI 26-43), and a positive predictive value of 57% (95% CI 54-61). A history of constant swelling (versus none or intermittent) showed a sensitivity of 46% (95% CI 37-54), a specificity of 75% (95% CI 67-82), and a positive predictive value of 66% (95% CI 58-74). CONCLUSION: We found that the sensitivity and specificity of patient-reported swelling were modest when compared with effusion-synovitis detected by MRI. These data urge caution against using patient-reported swelling as a proxy of inflammation manifesting as effusion-synovitis.

The TeMPO trial (treatment of meniscal tears in osteoarthritis): rationale and design features for a four arm randomized controlled clinical trial.

BACKGROUND: Meniscal 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. METHODS: The 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. DISCUSSION: The 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 REGISTRATION: The TeMPO Trial was first registered at clinicaltrials.gov with registration No. NCT03059004 . on February 14, 2017.

Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear.

BACKGROUND: Sufficient lower extremity muscle strength is necessary for performing functional tasks, and individuals with knee osteoarthritis demonstrate thigh muscle weakness compared to controls. It has been suggested that lower muscle strength is associated with a variety of clinical features including pain, mobility, and functional performance, yet these relationships have not been fully explored in patients with symptomatic meniscal tear in addition to knee osteoarthritis. Our purpose was to evaluate the associations of quadriceps and hamstrings muscle strength with structural damage and clinical features in individuals with knee osteoarthritis and symptomatic meniscal tear. METHODS: We performed a cross-sectional study using baseline data from the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial. We assessed structural damage using Kellgren-Lawrence grade and the magnetic resonance imaging osteoarthritis knee score (MOAKS) for cartilage damage. We used the Knee Injury and Osteoarthritis Outcomes Score (KOOS) to evaluate pain, symptoms, and activities of daily living (ADL), and the Timed Up and Go (TUG) test to assess mobility. We assessed quadriceps and hamstrings strength using a hand-held dynamometer and classified each into quartiles (Q). We used Chi square tests to evaluate the association between strength and structural damage; and separate analysis of covariance models to establish the association between pain, symptoms, ADL and mobility with strength, after adjusting for demographic characteristics (age, sex and BMI) and structural damage. RESULTS: Two hundred fifty two participants were evaluated. For quadriceps strength, subjects in the strongest quartile scored 14 and 13 points higher on the KOOS Pain and ADL subscales, respectively, and completed the TUG two seconds faster than subjects in the weakest quartile. For hamstrings strength, subjects in the strongest quartile scored 13 and 14 points higher on the KOOS pain and ADL subscales, respectively, and completed the TUG two seconds faster than subjects in the weakest quartile. Strength was not associated with structural damage. CONCLUSIONS: Greater quadriceps and hamstrings muscle strength was associated with less pain, less difficulty completing activities of daily living, and better mobility. These relationships should be evaluated longitudinally.

Predictors and Outcomes of Crossover to Surgery from Physical Therapy for Meniscal Tear and Osteoarthritis: A Randomized Trial Comparing Physical Therapy and Surgery.

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.

Defining the Value of Future Research to Identify the Preferred Treatment of Meniscal Tear in the Presence of Knee Osteoarthritis.

BACKGROUND: Arthroscopic 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. METHODS: We 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. RESULTS: Calculated 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. CONCLUSIONS: We 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.

Surgery versus physical therapy for a meniscal tear and osteoarthritis.

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. 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. 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. RESULTS: In 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. CONCLUSIONS: In 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.).

The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features.

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 moderate knee osteoarthritic change (OA). The design and execution of a trial that compares surgery with a nonoperative treatment strategy presents distinctive challenges. The goal of this paper is to provide the clinical rationale for MeTeOR and to highlight salient design features, with particular attention to those that present clinical and methodologic challenges.

Home health and home care in Massachusetts after the Balanced Budget Act of 1997: implications of cost containment pressures for service authorizations.

This paper explores the response of the Massachusetts state-funded home care program for the elderly when its clients encountered barriers to the receipt of home health services because of HMO enrollment and the implementation of the Balanced Budget Act of 1997. Clients of three regional case management agencies serving the Massachusetts state home care program whose home care services were interrupted because of hospitalization between January 1 and April 30, 1999 and whose services were resumed after they returned home were studied. Detailed data are reported that show how the long-term personal assistance services provided through the state program were often complemented by temporary home health services after elders returned home. The multivariate analysis revealed that the authorization of state-funded personal care services was keyed to the status of home health aide services. After hospitalization, the presence of a home health aide reduced the likelihood of authorization of personal care. At final assessment, the situation was reversed, that is, the withdrawal of a home health aide increased the likelihood of authorization of personal care. The findings suggest that more restrictive Medicare reimbursement policies for home health services led to greater state expenditures for personal care services. In other words, less generous Medicare financing shifted a greater portion of the burden of financing home care to the state of Massachusetts. These findings raise important policy questions about the balance of responsibility between the federal government and states to provide financing of home care services for the elderly.