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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Neil Katz, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00597012
First received: January 8, 2008
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Procedure: Arthroscopic partial menisectomy
Other: Standard physical therapy
Other: Postoperative rehabilitative physical therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partial Meniscectomy Versus Nonoperative Management in Meniscal Tear With OA: A Randomized Controlled Trial (MeTeOR)

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • WOMAC Functional Status - Difference From Baseline [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • KOOS Pain - Difference From Baseline [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 351
Study Start Date: May 2008
Estimated Study Completion Date: August 2016
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
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: Postoperative rehabilitative physical therapy
This physical therapy is geared specifically toward rehabilitation after APM surgery.
Active Comparator: 2
Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597012

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University in St Louis, School of Medicine
St Louis, Missouri, United States, 63110
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Jeffrey N. Katz, MD, MS Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Jeffrey Neil Katz, MD, Professor of Medicine and Orthopedic Surgery, Harvard Medical School; Director, Orthopaedic and Arthritis Center for Outcomes Research, Brigham & Women's Hospital, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00597012     History of Changes
Other Study ID Numbers: R01 AR055557
Study First Received: January 8, 2008
Results First Received: August 2, 2013
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Brigham and Women's Hospital:
Meniscal Tear
Osteoarthritis
Arthroscopic Partial Meniscectomy
Physical Therapy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 22, 2014