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

NCT00597012 | Active Not Recruiting Results DMC

• 1 other identifier: R01AR055557
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 7

Brief 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 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.

Conditions

Osteoarthritis

Keywords

Meniscal Tear; Osteoarthritis; Arthroscopic Partial Meniscectomy; Physical Therapy; Total Knee Arthroplasty; Total Knee Replacement

Outcome Measures

Primary Outcomes (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.

  Baseline and 6 months

Secondary Outcomes (4)

• KOOS Pain - Difference From Baseline

  Baseline to 6 months

• SF-36 Physical Functional Status Scale - Difference From Baseline

  6 months

• Total Knee Replacement - Subjects Received

  Baseline to 60 months

• KOOS Pain - Mean at 60 Months

  60 months

Study Arms (2)

Surgical

EXPERIMENTAL

Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.

Procedure: Arthroscopic partial menisectomy; Other: Postoperative rehabilitative physical therapy

Nonoperative

ACTIVE COMPARATOR

Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.

Other: Standard physical therapy

Interventions

Arthroscopic partial menisectomy PROCEDURE

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.

Surgical

Standard physical therapy OTHER

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.

Nonoperative

Postoperative rehabilitative physical therapy OTHER

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

Surgical

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (7)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University in St Louis, School of Medicine

St Louis, Missouri, 63110, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (17)

• 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.

  PMID: 22968127 BACKGROUND

• 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.

  PMID: 23506518 BACKGROUND

• 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.

  PMID: 27067990 BACKGROUND

• 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.

  PMID: 27296899 BACKGROUND

• 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.

  PMID: 27852905 BACKGROUND

• 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.

  PMID: 27390312 BACKGROUND

• 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.

  PMID: 28043939 BACKGROUND

• 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.

  PMID: 28978308 BACKGROUND

• 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.

  PMID: 30049269 BACKGROUND

• 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.

  PMID: 30133187 BACKGROUND

• 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.

  PMID: 30653921 BACKGROUND

• 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.

  PMID: 29726627 BACKGROUND

• 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.

  PMID: 30932360 BACKGROUND

• 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.

  PMID: 31429198 BACKGROUND

• 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.

  PMID: 35245416 DERIVED

• Katz JN, Collins JE, Jones M, Spindler KP, Marx RG, Mandl LA, Levy BA, Wright R, Jarraya M, Guermazi A, MacFarlane LA, Losina E, Chang Y. Association Between Structural Change Over Eighteen Months and Subsequent Symptom Change in Middle-Aged Patients Treated for Meniscal Tear. Arthritis Care Res (Hoboken). 2023 Feb;75(2):340-347. doi: 10.1002/acr.24796. Epub 2022 Oct 21.

  PMID: 34606692 DERIVED

• MacFarlane LA, Yang H, Collins JE, Brophy RH, Cole BJ, Spindler KP, Guermazi A, Jones MH, Mandl LA, Martin S, Marx RG, Levy BA, Stuart M, Safran-Norton C, Wright J, Wright RW, Losina E, Katz JN. Association Between Baseline Meniscal Symptoms and Outcomes of Operative and Nonoperative Treatment of Meniscal Tear in Patients With Osteoarthritis. Arthritis Care Res (Hoboken). 2022 Aug;74(8):1384-1390. doi: 10.1002/acr.24588. Epub 2022 May 6.

  PMID: 33650303 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Surgical randomized controlled trials present methodological challenges, including crossover from one group to the other.

Results Point of Contact

• Title: Jeffrey N. Katz, MD, MSc
• Organization: The Brigham and Women's Hospital

jnkatz@bwh.harvard.edu

617-732-5338

Study Officials

• Jeffrey N. Katz, MD, MS

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Orthopedic Surgery, Harvard Medical School; Director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham & Women's Hospital

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: May 1, 2008
• Primary Completion: February 1, 2012
• Study Completion: December 1, 2025
• Last Updated: October 3, 2025
• Results First Posted: January 27, 2014

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)