Status:
ACTIVE_NOT_RECRUITING
Multicenter ACL Revision Study (MARS)
Lead Sponsor:
Vanderbilt University
Collaborating Sponsors:
Vanderbilt University Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions:
Rupture of Anterior Cruciate Ligament
Eligibility:
All Genders
12-65 years
Brief Summary
The purpose of this study is to determine the effects of modifiable risk factors on patient-reported quality of life, physical activity levels, and risk of early osteoarthritis following revision ante...
Detailed Description
Injury to the anterior cruciate ligament (ACL) results in a threat to an active lifestyle and exposes the patient to risk of osteoarthritis. ACL reconstruction is typically chosen by individuals to al...
Eligibility Criteria
Inclusion
- All ACL-deficient candidates presenting to the clinic, between the ages of 12† and 65, scheduled to have a revision ACL reconstruction by a participating (MARS Study) surgeon.
- All participants must have undergone a primary ACL reconstruction in the past and are currently identified as having experienced failure of their primary ACL reconstruction, as defined by either MRI, knee laxity (KT \> 5mm), a positive pivot shift or Lachman's, functional instability, and/or by arthroscopic confirmation.
- All ACL-deficient patients seeking a revision ACL reconstruction that have either partial (Grade I or II) and/or complete (Grade III) simultaneous ligamentous injuries to the collateral ligaments (MCL or LCL) and/or the posterior cruciate ligament (PCL) will also be included.
- Non-operative treatment of patients with ACLR failure are also eligible to participate.
- The following graft types will be the only ones accepted for inclusion:
- any autograft
- Fresh-frozen allografts from a single donor source (Musculoskeletal Transplant Foundation (MTF); Edison, NJ). These grafts should consist of either:
- bone-patellar tendon-bone
- tibialis anterior/posterior
- achilles tendon
Exclusion
- Patients presenting with prior infection, arthrofibrosis, or regional pain syndrome.
- Subjects will be excluded if their allograft source does not come from MTF.
- Patients unwilling or unable to complete their repeat questionnaire two years after their initial visit.
Key Trial Info
Start Date :
March 26 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2029
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT00625885
Start Date
March 26 2006
End Date
August 31 2029
Last Update
June 17 2025
Active Locations (49)
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1
Scripps Memorial Hospital (OrthoCal Healthcare)
La Jolla, California, United States, 92123
2
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90095
3
University of California - San Francisco
San Francisco, California, United States, 94143
4
Orthopaedic Associates of Aspen and Glenwood
Aspen, Colorado, United States, 81611