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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My knee scans show signs of bone spurs or cartilage damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
WOMAC Functional Status - Difference From Baseline
Secondary outcome measures
KOOS Pain - Difference From Baseline
KOOS Pain - Mean at 60 Months
SF-36 Physical Functional Status Scale - Difference From Baseline
+1 moreTrial 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.
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,526 Total Patients Enrolled
16 Trials studying Osteoarthritis
29,522 Patients Enrolled for Osteoarthritis
Jeffrey N. Katz, MD, MSPrincipal InvestigatorBrigham and Women's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no health issues preventing surgery or physical therapy.I experience symptoms like clicking, pain, or instability in my knee, suggesting a torn meniscus.My knee arthritis is severe, possibly needing a knee replacement.I have had osteoarthritis symptoms for over a month and have been managing it with medication, limiting activities, or physical therapy.I have an inflammatory disease like rheumatoid arthritis or lupus.I cannot or do not want to go to physical therapy sessions at specific places.I am willing to be randomly assigned to a treatment group and sign a consent form.I have calcium deposits in my cartilage and symptoms of pseudogout.My knee is permanently stiff and cannot bend.I have not had a knee injection for joint cushioning in the last 4 weeks.Both of my knees are affected by meniscal tears and I am a candidate for surgery on both.My knee scans show signs of bone spurs or cartilage damage.I have had surgery on my knee before.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In how many locations is this trial being conducted?
"Currently, 7 medical institutes are overseeing this trial. These include Brigham and Women's Hospital in Boston, Rush University Medical Center in Chicago, and the Hospital for Special Surgery located in New york City; other sites round out the total number of participating locations."
Answered by AI
Are applications still being accepted for this experiment?
"According to clinicaltrials.gov, this trial has since concluded its recruitment period, having last been edited on September 13th 2022 after initially being posted in May of 2008. Nevertheless, 613 other medical studies are still actively recruiting patients for their trials."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Hospital for Special Surgery
What portion of applicants met pre-screening criteria?
Met criteria
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