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

Not Applicable

Active, not recruiting

Conditions: Osteoarthritis

Interventions: Other: Standard physical therapy
Procedure: Arthroscopic partial menisectomy
Other: Postoperative rehabilitative physical therapy

Registration Number: NCT00597012

Lead Sponsor: Brigham and Women's Hospital

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.

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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 351

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical	Postoperative rehabilitative physical therapy	Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
Nonoperative	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.
Surgical	Arthroscopic partial menisectomy	Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.

Primary Outcome Measures

Name	Time	Method
WOMAC Functional Status - Difference From Baseline	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

Name	Time	Method
KOOS Pain - Difference From Baseline	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.
KOOS Pain - Mean at 60 Months	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.
SF-36 Physical Functional Status Scale - Difference From Baseline	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.
Total Knee Replacement - Subjects Received	Baseline to 60 months	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.

Trial Locations

Locations (7): Washington University in St Louis, School of Medicine
🇺🇸
Saint Louis, Missouri, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Hospital for Special Surgery
🇺🇸
New York, New York, United States
Vanderbilt University
🇺🇸
Nashville, Tennessee, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States