Osteoarthritis Clinical Trial
Official title:
Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)
Verified date | September 2022 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
There are two cartilage structures, called menisci, in each knee joint. A torn meniscus can be caused by a traumatic injury or aging-related degeneration. Osteoarthritis (OA) is a type of arthritis that is caused by the breakdown and eventual loss of another type of cartilage that covers the end of bones within a joint. In people who have knee OA, a meniscal tear can easily lead to disability. This study will compare the effectiveness of two recommended treatments, surgery and physical therapy, for people with a torn meniscus and knee OA.
Status | Active, not recruiting |
Enrollment | 351 |
Est. completion date | August 2025 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | Inclusion Criteria: - OA symptoms lasting at least 1 month and managed with medications, activity limitations, and/or physical therapy - At least one symptom consistent with a torn meniscus. Symptoms may include clicking, catching, popping, giving way, pain with pivot or torque, episodic pain, and/or pain that is acute and localized to one joint line. - Available knee X-ray (within 6 months) and MRI (within 3 years) - Evidence of osteophyte formation or cartilage fissure, tear, or loss on a knee MRI OR plain radiographic evidence of osteophyte formation or joint space narrowing - Evidence of a meniscal tear (tear extending to surface of meniscus) on a knee MRI - Willingness to undergo random assignment and sign an informed consent Exclusion Criteria: - Chronically locked knee - Kellgren-Lawrence Grade IV status, indicating advanced OA and usually the need for total knee replacement - Contraindication to MRI - Radiographic chondrocalcinosis (a condition in which there are deposits of calcium pyrophosphate dihydrate [CPPD] crystals in one or more joints that eventually result in damage to the affected joints) AND acute symptomatic pseudogout - Inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout) - Injection with viscosupplementation in the affected knee in the 4 weeks before study entry - Any medical contraindications to surgery or physical therapy - Both knees are symptomatic for meniscal tears and a candidate for bilateral APMs - Prior surgery on an affected knee - Pregnancy or possible pregnancy - Claim filed for worker's compensation - Unable or unwilling to give informed consent - Unable or unwilling to attend physical therapy sessions at designated locations or in the community |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Hospital for Special Surgery | New York | New York |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Washington University in St Louis, School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Collins JE, Losina E, Marx RG, Guermazi A, Jarraya M, Jones MH, Levy BA, Mandl LA, Martin SD, Wright RW, Spindler KP, Katz JN; MeTeOR Investigator Group. Early Magnetic Resonance Imaging-Based Changes in Patients With Meniscal Tear and Osteoarthritis: Eighteen-Month Data From a Randomized Controlled Trial of Arthroscopic Partial Meniscectomy Versus Physical Therapy. Arthritis Care Res (Hoboken). 2020 May;72(5):630-640. doi: 10.1002/acr.23891. — View Citation
Deshpande BR, Losina E, Smith SR, Martin SD, Wright RJ, Katz JN. Association of MRI findings and expert diagnosis of symptomatic meniscal tear among middle-aged and older adults with knee pain. BMC Musculoskelet Disord. 2016 Apr 11;17:154. doi: 10.1186/s12891-016-1010-2. — View Citation
Katz JN, Brophy RH, Chaisson CE, de Chaves L, Cole BJ, Dahm DL, Donnell-Fink LA, Guermazi A, Haas AK, Jones MH, Levy BA, Mandl LA, Martin SD, Marx RG, Miniaci A, Matava MJ, Palmisano J, Reinke EK, Richardson BE, Rome BN, Safran-Norton CE, Skoniecki DJ, Solomon DH, Smith MV, Spindler KP, Stuart MJ, Wright J, Wright RW, Losina E. Surgery versus physical therapy for a meniscal tear and osteoarthritis. N Engl J Med. 2013 May 2;368(18):1675-84. doi: 10.1056/NEJMoa1301408. Epub 2013 Mar 18. Erratum in: N Engl J Med. 2013 Aug 15;369(7):683. — View Citation
Katz JN, Chaisson CE, Cole B, Guermazi A, Hunter DJ, Jones M, Levy BA, Mandl LA, Martin S, Marx RG, Safran-Norton C, Roemer FW, Skoniecki D, Solomon DH, Spindler KP, Wright J, Wright RW, Losina E. The MeTeOR trial (Meniscal Tear in Osteoarthritis Research): rationale and design features. Contemp Clin Trials. 2012 Nov;33(6):1189-96. doi: 10.1016/j.cct.2012.08.010. Epub 2012 Sep 5. — View Citation
Katz JN, Shrestha S, Losina E, Jones MH, Marx RG, Mandl LA, Levy BA, MacFarlane LA, Spindler KP, Silva GS; METEOR Investigators, Collins JE. Five-Year Outcome of Operative and Nonoperative Management of Meniscal Tear in Persons Older Than Forty-Five Years. Arthritis Rheumatol. 2020 Feb;72(2):273-281. doi: 10.1002/art.41082. Epub 2019 Dec 15. — View Citation
Katz JN, Smith SR, Yang HY, Martin SD, Wright J, Donnell-Fink LA, Losina E. Value of History, Physical Examination, and Radiographic Findings in the Diagnosis of Symptomatic Meniscal Tear Among Middle-Aged Subjects With Knee Pain. Arthritis Care Res (Hoboken). 2017 Apr;69(4):484-490. doi: 10.1002/acr.22975. Epub 2017 Mar 3. — View Citation
Katz JN, Wright J, Spindler KP, Mandl LA, Safran-Norton CE, Reinke EK, Levy BA, Wright RW, Jones MH, Martin SD, Marx RG, Losina E. Predictors and Outcomes of Crossover to Surgery from Physical Therapy for Meniscal Tear and Osteoarthritis: A Randomized Trial Comparing Physical Therapy and Surgery. J Bone Joint Surg Am. 2016 Nov 16;98(22):1890-1896. Erratum in: J Bone Joint Surg Am. 2018 Jul 18;100(14):e100. — View Citation
Luc-Harkey BA, Safran-Norton CE, Mandl LA, Katz JN, Losina E. Associations among knee muscle strength, structural damage, and pain and mobility in individuals with osteoarthritis and symptomatic meniscal tear. BMC Musculoskelet Disord. 2018 Jul 27;19(1):258. doi: 10.1186/s12891-018-2182-8. — View Citation
MacFarlane LA, Yang H, Collins JE, Guermazi A, Jones MH, Spindler KP, Winter AR, Losina E, Katz JN; the MeTeOR Investigator Group, Brophy RH, Cole BJ, Levy BA, Mandl LA, Martin S, Marx RG, Matava M, Safran-Norton C, Stuart M, Wright R. Influence of Baseline Magnetic Resonance Imaging Features on Outcome of Arthroscopic Meniscectomy and Physical Therapy Treatment of Meniscal Tears in Osteoarthritis. Am J Sports Med. 2019 Mar;47(3):612-619. doi: 10.1177/0363546518819444. Epub 2019 Jan 17. — View Citation
MacFarlane LA, Yang H, Collins JE, Guermazi A, Jones MH, Teeple E, Xu L, Losina E, Katz JN. Associations among meniscal damage, meniscal symptoms and knee pain severity. Osteoarthritis Cartilage. 2017 Jun;25(6):850-857. doi: 10.1016/j.joca.2016.12.023. Epub 2016 Dec 30. — View Citation
MacFarlane LA, Yang H, Collins JE, Guermazi A, Mandl LA, Levy BA, Marx RG, Safran-Norton CE, Losina E, Katz JN; Meniscal Tear in Osteoarthritis Research Investigator Group. Relationship Between Patient-Reported Swelling and Magnetic Resonance Imaging-Defined Effusion-Synovitis in Patients With Meniscus Tears and Knee Osteoarthritis. Arthritis Care Res (Hoboken). 2019 Mar;71(3):385-389. doi: 10.1002/acr.23592. — View Citation
MacFarlane LA, Yang H, Collins JE, Jarraya M, Guermazi A, Mandl LA, Martin SD, Wright J, Losina E, Katz JN; MeTeOR Investigator Group. Association of Changes in Effusion-Synovitis With Progression of Cartilage Damage Over Eighteen Months in Patients With Osteoarthritis and Meniscal Tear. Arthritis Rheumatol. 2019 Jan;71(1):73-81. doi: 10.1002/art.40660. Epub 2018 Nov 29. — View Citation
Tuakli-Wosornu YA, Selzer F, Losina E, Katz JN. Predictors of Exercise Adherence in Patients With Meniscal Tear and Osteoarthritis. Arch Phys Med Rehabil. 2016 Nov;97(11):1945-1952. doi: 10.1016/j.apmr.2016.05.011. Epub 2016 Jun 11. — View Citation
Winter AR, Collins JE, Katz JN. The likelihood of total knee arthroplasty following arthroscopic surgery for osteoarthritis: a systematic review. BMC Musculoskelet Disord. 2017 Oct 4;18(1):408. doi: 10.1186/s12891-017-1765-0. Review. Erratum in: BMC Musculoskelet Disord. 2022 Jul 25;23(1):709. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | WOMAC Functional Status - Difference From Baseline | Scores on the physical-function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) range from 0 to 100, with higher scores indicating more limitation of physical function. 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) from baseline to 6 months after randomization. | Baseline and 6 months | |
Secondary | KOOS Pain - Difference From Baseline | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the difference between the study groups with respect to the change in the score on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) from baseline to 6 months after randomization. | Baseline to 6 months | |
Secondary | SF-36 Physical Functional Status Scale - Difference From Baseline | Scores on the physical-activity scale of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) range from 0 to 100, with higher scores indicating greater physical activity. | 6 months | |
Secondary | Total Knee Replacement - Subjects Received | Number of subjects that elected to undergo Total Knee Replacement or Total Knee Arthroplasty between baseline and 60 month follow up. Intended to show the total number of participants that underwent Total Knee Replacement in the period following the initial intervention through 60 month follow up. | Baseline to 60 months | |
Secondary | KOOS Pain - Mean at 60 Months | Scores on the pain scale of the Knee Injury and Osteoarthritis Outcome Scale (KOOS) range from 0 to 100, with higher scores indicating more pain. The secondary outcome was the mean KOOS pain for each of the study groups 60 months after randomization. | 60 months |
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