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OsteoarthritisNCT00597012

Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis

A study testing Arthroscopic partial menisectomy, Standard physical therapy and Postoperative rehabilitative physical therapy in people with Osteoarthritis, run by Brigham and Women's Hospital at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Arthroscopic partial menisectomy, Standard physical therapy and Postoperative rehabilitative physical therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
7 sitesUnited States
Study dates
May 2008to Dec 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Hospital for Special Surgery

    New York, New York, 10021

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Washington University in St Louis, School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)

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.

Read the detailed description

OA is the most common form of arthritis in the United States. Symptoms of knee OA include pain in and around the knee that typically worsens with weight-bearing activities, morning stiffness, and tenderness. A person with OA who experiences a torn meniscus--a cartilage structure within the knee that provides stability and proper weight distribution--is especially at risk for disability. Past studies have shown that arthroscopic partial meniscectomy (APM), a type of knee surgery, usually relieves symptoms and improves function in people suffering from a meniscal tear. However, the success of APM is more variable among people with already existing OA. Clinicians are also uncertain about the short- and long-term benefits, drawbacks, and indications for APM in people with OA and meniscal tears. The purpose of this study is to compare the effectiveness of two treatments, APM surgery and standard physical therapy, for people with OA and a torn meniscus.

This study will last 12 years. At the initial study visit, participants will be randomly assigned to one of two groups.

  • Group 1 participants will undergo APM surgery at a time that is convenient for the participant and surgeon. After surgery, participants will be referred for rehabilitative physical therapy to regain strength and flexibility of the knee. For participants who choose to do physical therapy, the duration of treatment will depend on individual progress.
  • Group 2 participants will receive standard physical therapy to increase strength and flexibility of the knee. This will include one to three weekly exercise sessions over an 8-week period.

The study consists of up to 5 visits to the center:

  • Visit 1, the enrollment visit: sign the consent form, fill out a questionnaire, have a physical examination of the knee and find out your treatment group (surgery or physical therapy
  • Visit 2, at 3 months after enrollment: Fill out a questionnaire and have a physical examination of the knee
  • Visit 3, at 18 months: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees
  • Visit 4, at 5 years: Fill out a questionnaire, have an MRI of the knee (if eligible) and xrays of both knees
  • Visit 5, at 12 years: Fill out a questionnaire, have a physical examination of the knee, have an MRI of the knee (if eligible) and xrays of both knees

Telephone calls: During the first 3 months of the study, all participants will receive check-up phone calls every 2 weeks, followed by quarterly phone calls for the initial 2 years in the study

Questionnaires: Participants will also complete mailed questionnaires at 6 months, and 1, 2, 2.5, 3, 3.5, 4, 4.5, 5, and 12 years after enrollment. The questionnaires will include questions about knee pain, ability to walk, recreational activities, general health, and satisfaction with with treatment.

Conditions
Osteoarthritis
Being tested
Arthroscopic partial menisectomy, Standard physical therapy, Postoperative rehabilitative physical therapy
Keywords
Meniscal Tear, Osteoarthritis, Arthroscopic Partial Meniscectomy, Physical Therapy, Total Knee Arthroplasty, Total Knee Replacement
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arthroscopic partial menisectomyProcedure or surgery

    Arthroscopic partial meniscectomy is a surgical procedure that is performed to remove a piece of torn cartilage in the knee joint. Incisions for arthroscopy are quite small, usually about 1 centimeter each. The torn meniscus can be removed using a number of different instruments, including small shavers and scissors.

  • Standard physical therapyOther

    Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks. This physical therapy regimen will have similar elements and goals as the postoperative intervention offered to Group 1 participants.

  • Postoperative rehabilitative physical therapyOther

    This physical therapy is geared specifically toward rehabilitation after APM surgery.

Study groups in NCT00597012
Study groupRoleWhat they receive
SurgicalExperimentalParticipants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
Receives: Procedure: Arthroscopic partial menisectomy; Other: Postoperative rehabilitative physical therapy
NonoperativeActive comparatorParticipants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
Receives: Other: Standard physical therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months

Secondary outcomes (4)
  1. 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.

    Measured: Baseline to 6 months

  2. 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.

    Measured: 6 months

  3. 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.

    Measured: Baseline to 60 months

  4. 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.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2012
  4. Study completionDec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00597012
Sponsor's protocol ID
R01AR055557
Status last verified
May 2026
First submitted
8 Jan 2008
Last updated
18 May 2026
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22968127
  • 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.

    PubMed 23506518
  • 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.

    PubMed 27067990
  • 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.

    PubMed 27296899
  • 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. doi: 10.2106/JBJS.15.01466.

    PubMed 27852905
  • 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.

    PubMed 27390312
  • 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.

    PubMed 28043939
  • 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.

    PubMed 28978308
  • 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.

    PubMed 30049269
  • 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.

    PubMed 30133187
  • 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.

    PubMed 30653921
  • 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.

    PubMed 29726627
  • 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.

    PubMed 30932360
  • 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.

    PubMed 31429198
  • Collins JE, Shrestha S, Losina E, Marx RG, Guermazi A, Jarraya M, Jones MH, Levy BA, Mandl LA, Williams EE, Wright RW, Spindler KP, Katz JN; METEOR Investigator Group. Five-Year Structural Changes in the Knee Among Patients With Meniscal Tear and Osteoarthritis: Data From a Randomized Controlled Trial of Arthroscopic Partial Meniscectomy Versus Physical Therapy. Arthritis Rheumatol. 2022 Aug;74(8):1333-1342. doi: 10.1002/art.42105. Epub 2022 Jun 28.

    PubMed 35245416

Questions about this trial

What is this clinical trial studying?

A study testing Arthroscopic partial menisectomy, Standard physical therapy and Postoperative rehabilitative physical therapy in people with Osteoarthritis, run by Brigham and Women's Hospital at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

WOMAC Functional Status - Difference From Baseline (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00597012, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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