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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00597012
Recruitment Status : Active, not recruiting
First Posted : January 17, 2008
Results First Posted : January 27, 2014
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey Neil Katz, MD, Brigham and Women's Hospital

Tracking Information
First Submitted Date  ICMJE January 8, 2008
First Posted Date  ICMJE January 17, 2008
Results First Submitted Date  ICMJE August 2, 2013
Results First Posted Date  ICMJE January 27, 2014
Last Update Posted Date November 13, 2019
Study Start Date  ICMJE May 2008
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 16, 2008)
  • Pain relief [ Time Frame: At end of study (Year 2) ]
  • Improvement in functional status [ Time Frame: At end of study (Year 2) ]
Change History Complete list of historical versions of study NCT00597012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Knee Cartilage Surgery Versus Standard Physical Therapy in Treating People With a Meniscal Tear and Osteoarthritis
Official Title  ICMJE Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)
Brief 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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: 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.
  • Other: Postoperative rehabilitative physical therapy
    This physical therapy is geared specifically toward rehabilitation after APM surgery.
Study Arms  ICMJE
  • Experimental: Surgical
    Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
    Interventions:
    • Procedure: Arthroscopic partial menisectomy
    • Other: Postoperative rehabilitative physical therapy
  • 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.
    Intervention: Other: Standard physical therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
351
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2008)
340
Estimated Study Completion Date  ICMJE August 2022
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00597012
Other Study ID Numbers  ICMJE R01AR055557( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeffrey Neil Katz, MD, Brigham and Women's Hospital
Study Sponsor  ICMJE Brigham and Women's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey N. Katz, MD, MS Brigham and Women's Hospital
PRS Account Brigham and Women's Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP