Multicenter ACL Revision Study (MARS)
- Conditions
- Rupture of Anterior Cruciate Ligament
- Registration Number
- NCT00625885
- Lead Sponsor
- Vanderbilt University
- 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 anterior cruciate ligament (ACL) reconstruction.
The investigators hypothesize that modifiable variables exist at the time of revision ACL reconstruction (e.g., cause of failure, current graft source and type, surgical exposure, and femoral and tibial tunnel position) which will be predictors of patient-reported outcomes.
- 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 allow a return to their previous work and sports activities. The results of primary ACL reconstruction have in general been good at restoring functional stability. Primary ACL reconstruction has a graft failure rate ranging from approximately 2%-8%. Consensus amongst surgeons and low-level evidence (retrospective case series) indicate a worse outcome following revision ACL reconstruction compared to primary reconstruction. The typical surgeon performs less than 10 revision ACL reconstructions per year. Thus, the ability of any single surgeon or small group of surgeons to accumulate enough cases to effectively analyze predictors for worse outcome is impossible.
With this in mind, the Multi-Center ACL Revision Study (MARS) group was established as a multi-center surgeon group to perform a prospective longitudinal cohort analysis of revision ACL reconstruction. This is a mixed group of academic and private practice physicians and has been supported and endorsed by the American Orthopedic Society for Sports Medicine (AOSSM).
This study focuses on the predictors for ACL revision outcome at 2, 6, and 10 years following a patient's revision ACL reconstruction. This will be accomplished by three Specific Aims. Specific Aim 1 will determine the independent predictors of patient-reported quality of life, utilizing a general (SF-36) and knee-specific (Knee Injury and Osteoarthritis Outcome Score - KOOS) validated outcome instrument. Specific Aim 2 will determine the independent predictors of sports function utilizing three validated outcome instruments (the Marx activity level, International Knee Documentation Committee Subjective form - IKDC, and the KOOS sports and recreation subscale). Specific Aim 3 will identify those independent modifiable predictors measured at the time of the revision ACL reconstruction associated with symptoms of early osteoarthritis at 2, 6, and 10 years post-surgery. Symptoms will be quantified using the validated survey instrument the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Once the predictors for these worse outcomes are identified, surgeons can be educated in potential modifiable variables to improve the outcome.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1234
-
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
-
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Graft re-rupture 2, 6, 10, and 20 years after revision ACL surgery
- Secondary Outcome Measures
Name Time Method Patient based outcome measures 2, 6,10, and 20 years after revision ACL surgery Activity level (as measured by the Marx activity scale). Sports function (as measured by the KOOS and IKDC). Pain and swelling (as measured by the WOMAC).
Trial Locations
- Locations (49)
Connecticut Children's Medical Center
🇺🇸Farmington, Connecticut, United States
Intermountain Orthopaedics
🇺🇸Boise, Idaho, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Princeton Orthopaedic Associates
🇺🇸Princeton, New Jersey, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
UHZ Sports Medicine Institute
🇺🇸Coral Gables, Florida, United States
University of Colorado
🇺🇸Boulder, Colorado, United States
Royal Columbian Hospital (FraserHealth)
🇨🇦New Westminster, British Columbia, Canada
University of Iowa
🇺🇸Iowa City, Iowa, United States
Methodist Sports Medicine Center
🇺🇸Indianapolis, Indiana, United States
Southeastern Orthopaedics / Knoxville Orthopaedic Clinic
🇺🇸Knoxville, Tennessee, United States
Cheaspeake Orthopaedics and Sports Medicine Center
🇺🇸Glen Burnie, Maryland, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Orthopaedic and Fracture Clinic
🇺🇸Portland, Oregon, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Regions Hospital (Health Partners Research Foundation)
🇺🇸Saint Paul, Minnesota, United States
Washington University at St. Louis
🇺🇸Saint Louis, Missouri, United States
Bridger Orthopaedic and Sports Medicine
🇺🇸Bozeman, Montana, United States
New Hamphsire Knee Center
🇺🇸Holderness, New Hampshire, United States
Keller Army Community Hospital - USMA
🇺🇸West Point, New York, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Duke University
🇺🇸Durham, North Carolina, United States
Commonwealth Orthopaedics and Rehabilitation
🇺🇸Vienna, Virginia, United States
University of Vermont College of Medicine
🇺🇸Burlington, Vermont, United States
Booth, Bartolozzi, Balderston Orthopaedics
🇺🇸Philadelphia, Pennsylvania, United States
University of North Carolina Medical Center
🇺🇸Chapel Hill, North Carolina, United States
Vanderbilt University
🇺🇸Nashville, Tennessee, United States
The Rothman Institute / Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
W.B. Carroll Memorial Clinic
🇺🇸Dallas, Texas, United States
San Antonio Orthopaedic Group
🇺🇸San Antonio, Texas, United States
Town Center Orthopaedic Associates
🇺🇸Reston, Virginia, United States
Inland Orthopaedics/Washington State University
🇺🇸Pullman, Washington, United States
National Sports Medicine Institute
🇺🇸Lansdowne Town Center, Virginia, United States
Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario
🇨🇦London, Ontario, Canada
Scripps Memorial Hospital (OrthoCal Healthcare)
🇺🇸La Jolla, California, United States
University of California - Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
University of California - San Francisco
🇺🇸San Francisco, California, United States
Orthopaedic Associates of Aspen and Glenwood
🇺🇸Aspen, Colorado, United States
Manhattan Orthopaedics, P.C.
🇺🇸New York, New York, United States
NYU School of Medicine
🇺🇸New York, New York, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Perry Orthopaedics and Sports Med (Carolinas Healthcare System)
🇺🇸Charlotte, North Carolina, United States
Hospital for Special Surgery
🇺🇸New York, New York, United States
Slocum Research and Education Foundation
🇺🇸Eugene, Oregon, United States
Orthopaedic Institute
🇺🇸Sioux Falls, South Dakota, United States