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Procedure

Knee Surgery vs Physical Therapy for Osteoarthritis

N/A
Waitlist Available
Led By Jeffrey N. Katz, MD, MS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
Inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gout, pseudogout)
Unable or unwilling to attend physical therapy sessions at designated locations or in the community
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

Summary

This trial will compare surgery and physical therapy for people with a torn meniscus and knee OA.

Who is the study for?
This trial is for people with a specific knee problem where the cushioning cartilage (meniscus) is torn and they also have osteoarthritis. They must have had symptoms for at least a month, tried some treatments like meds or physical therapy, and be okay with being randomly assigned to treatment groups. People can't join if they've had previous knee surgery on the affected leg, are pregnant, have certain other joint diseases or severe arthritis needing total knee replacement.
What is being tested?
The study compares two common treatments for meniscal tears in patients with osteoarthritis: one group will undergo arthroscopic partial meniscectomy followed by rehab physical therapy; another group will receive standard physical therapy without surgery. The goal is to see which approach helps more.
What are the potential side effects?
Surgery may lead to risks such as infection, blood clots, pain at the incision site, and complications from anesthesia. Physical therapy could cause muscle soreness or strain. Each person's reaction to treatment can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My knee scans show signs of bone spurs or cartilage damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an inflammatory disease like rheumatoid arthritis or lupus.
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I cannot or do not want to go to physical therapy sessions at specific places.
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My knee arthritis is severe, possibly needing a knee replacement.
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I have calcium deposits in my cartilage and symptoms of pseudogout.
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My knee is permanently stiff and cannot bend.
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Both of my knees are affected by meniscal tears and I am a candidate for surgery on both.
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I have had surgery on my knee before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
WOMAC Functional Status - Difference From Baseline
Secondary study objectives
KOOS Pain - Difference From Baseline
KOOS Pain - Mean at 60 Months
SF-36 Physical Functional Status Scale - Difference From Baseline
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SurgicalExperimental Treatment2 Interventions
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
Group II: NonoperativeActive Control1 Intervention
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Arthroscopic partial menisectomy
2009
N/A
~140

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,653 Previous Clinical Trials
11,490,684 Total Patients Enrolled
16 Trials studying Osteoarthritis
29,559 Patients Enrolled for Osteoarthritis
Jeffrey N. Katz, MD, MSPrincipal InvestigatorBrigham and Women's Hospital

Media Library

Arthroscopic partial menisectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00597012 — N/A
~20 spots leftby Sep 2025
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