N/A
N=351
Comparing Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT00597012 ↗Enrolled (actual)
351
Serious AEs
1.4%
Results posted
Jan 2014
Primary outcome: Primary: WOMAC Functional Status - Difference From Baseline — 20.9; 18.5 Score — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Arthroscopic partial menisectomy (Procedure); Standard physical therapy (Other); Postoperative rehabilitative physical therapy (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMAC Functional Status - Difference From Baseline |
20.9; 18.5 | 0.26 |
| SECONDARY KOOS Pain - Difference From Baseline |
24.2; 21.3 | 0.16 |
| SECONDARY SF-36 Physical Functional Status Scale - Difference From Baseline |
24.2; 23.1 | 0.68 |
| SECONDARY Total Knee Replacement - Subjects Received |
16; 9 | — |
| SECONDARY KOOS Pain - Mean at 60 Months |
18.2; 19.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00597012). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.