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

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.

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