Comparing Knee Cartilage Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT00597012|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2008
Results First Posted : January 27, 2014
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis||Procedure: Arthroscopic partial menisectomy Other: Standard physical therapy Other: Postoperative rehabilitative physical therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||351 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 2025|
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.
- 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.
- 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.
- 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.
- Total Knee Replacement - Subjects Received [ Time Frame: 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.
- KOOS Pain - Mean at 60 Months [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597012
|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|
|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, Ohio, United States, 44195|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Jeffrey N. Katz, MD, MS||Brigham and Women's Hospital|