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

• ClinicalTrials.gov Identifier: NCT00597012
• Recruitment Status: Active, not recruiting
• First Posted: January 17, 2008
• Results First Posted: January 27, 2014
• Last Update Posted: November 13, 2019
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Jeffrey Neil Katz, MD, Brigham and Women's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Procedure: Arthroscopic partial menisectomy; Other: Standard physical therapy; Other: Postoperative rehabilitative physical therapy	Not Applicable

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 5 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 3 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

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 and 5 years after enrollment. The questionnaires will include questions about knee pain, ability to walk, recreational activities, general health, and satisfaction with with treatment.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 351 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)
• Study Start Date: May 2008
• Actual Primary Completion Date: February 2012
• Estimated Study Completion Date: August 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Surgical; Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.	Procedure: Arthroscopic partial menisectomy; 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.; Other: Postoperative rehabilitative physical therapy; This physical therapy is geared specifically toward rehabilitation after APM surgery.
Active Comparator: Nonoperative; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. WOMAC Functional Status - Difference From Baseline [ Time Frame: Baseline and 6 months ]
   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.

Secondary Outcome Measures :

1. KOOS Pain - Difference From Baseline [ Time Frame: Baseline to 6 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 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.
2. SF-36 Physical Functional Status Scale - Difference From Baseline [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 45 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

United States, Minnesota

Mayo Clinic

Rochester, Minnesota, United States, 55905

United States, Missouri

Washington University in St Louis, School of Medicine

Saint Louis, Missouri, United States, 63110

United States, New York

Hospital for Special Surgery

New York, New York, United States, 10021

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Tennessee

Vanderbilt University

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

• Principal Investigator: Jeffrey N. Katz, MD, MS; Brigham and Women's Hospital

More Information

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Jeffrey Neil Katz, MD, Professor of Medicine and Orthopedic Surgery, Harvard Medical School; Director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham & Women's Hospital, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT00597012 History of Changes
• Other Study ID Numbers: R01AR055557 ( U.S. NIH Grant/Contract )
• First Posted: January 17, 2008
• Results First Posted: January 27, 2014
• Last Update Posted: November 13, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Jeffrey Neil Katz, MD, Brigham and Women's Hospital:

Meniscal Tear; Osteoarthritis; Arthroscopic Partial Meniscectomy; Physical Therapy

Additional relevant MeSH terms:

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases