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
Results First Received: August 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Osteoarthritis
Interventions: Procedure: Arthroscopic partial menisectomy
Other: Standard physical therapy
Other: Postoperative rehabilitative physical therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The Meniscal Tear in Osteoarthritis Research(MeTeOR) trial was performed in seven academic referral centers with enrollment occurring from June 2008 through August 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arthroscopic Partial Meniscectomy (APM) Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
Physical Therapy (PT) Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.

Participant Flow:   Overall Study
    Arthroscopic Partial Meniscectomy (APM)     Physical Therapy (PT)  
STARTED     174     177  
COMPLETED     161     169  
NOT COMPLETED     13     8  
Death                 1                 1  
Underwent Total Knee Replacement (TKR)                 3                 1  
Withdrawal by Subject                 7                 4  
Ineligible                 2                 0  
Lost to Follow-up                 0                 2  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   WOMAC Functional Status - Difference From Baseline   [ Time Frame: Baseline and 6 months ]

2.  Secondary:   KOOS Pain - Difference From Baseline   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   SF-36 Physical Functional Status Scale - Difference From Baseline   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Surgical randomized controlled trials present methodological challenges, including crossover from one group to the other.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jeffrey N. Katz, MD, MSc
Organization: The Brigham and Women's Hospital
phone: 617-732-5338
e-mail: jnkatz@partners.org


Publications:

Responsible Party: Jeffrey Neil Katz, MD, 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