Multicenter ACL Revision Study (MARS)
This trial is active, not recruiting.
|Condition||rupture of anterior cruciate ligament|
|Collaborator||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Start date||February 2007|
|End date||December 2021|
|Trial size||1250 participants|
|Trial identifier||NCT00625885, 070110, R01AR060846|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|LaJolla, CA||Scripps Memorial Hospital (OrthoCal Healthcare)||no longer recruiting|
|Los Angeles, CA||University of California - Los Angeles (UCLA)||no longer recruiting|
|San Francisco, CA||University of California - San Francisco||no longer recruiting|
|Aspen, CO||Orthopaedic Associates of Aspen and Glenwood||no longer recruiting|
|Boulder, CO||University of Colorado||no longer recruiting|
|Farmington, CT||Connecticut Children's Medical Center||no longer recruiting|
|Farmington, CT||University of Connecticut Health Center||no longer recruiting|
|Coral Gables, FL||UHZ Sports Medicine Institute||no longer recruiting|
|Boise, ID||Intermountain Orthopaedics||no longer recruiting|
|Chicago, IL||Rush University Medical Center||no longer recruiting|
|Rosemont, IL||American Orthopaedic Society for Sports Medicine (AOSSM)||no longer recruiting|
|Indianapolis, IN||Methodist Sports Medicine Center||no longer recruiting|
|Iowa City, IA||University of Iowa||no longer recruiting|
|Glen Burnie, MD||Cheaspeake Orthopaedics and Sports Medicine Center||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Ann Arbor, MI||University of Michigan||no longer recruiting|
|Rochester, MN||Mayo Clinic||no longer recruiting|
|St. Paul, MN||Regions Hospital (Health Partners Research Foundation)||no longer recruiting|
|St. Louis, MO||Washington University at St. Louis||no longer recruiting|
|Bozeman, MT||Bridger Orthopaedic and Sports Medicine||no longer recruiting|
|Holderness, NH||New Hamphsire Knee Center||no longer recruiting|
|New Brunswick, NJ||Robert Wood Johnson Medical School||no longer recruiting|
|Princeton, NJ||Princeton Orthopaedic Associates||no longer recruiting|
|Buffalo, NY||University of Buffalo||no longer recruiting|
|New York, NY||NYU School of Medicine||no longer recruiting|
|New York, NY||Hospital for Special Surgery||no longer recruiting|
|New York, NY||Manhattan Orthopaedics, P.C.||no longer recruiting|
|West Point, NY||Keller Army Community Hospital - USMA||no longer recruiting|
|Chapel Hill, NC||University of North Carolina Medical Center||no longer recruiting|
|Charlotte, NC||Perry Orthopaedics and Sports Med (Carolinas Healthcare System)||no longer recruiting|
|Cleveland, OH||University Hospitals of Cleveland (Case Western)||no longer recruiting|
|Cleveland, OH||Cleveland Clinic||no longer recruiting|
|Columbus, OH||The Ohio State University||no longer recruiting|
|Eugene, OR||Slocum Research and Education Foundation||no longer recruiting|
|Portland, OR||Orthopaedic and Fracture Clinic||no longer recruiting|
|Philadelphia, PA||The Rothman Institute / Thomas Jefferson University||no longer recruiting|
|Philadelphia, PA||Booth, Bartolozzi, Balderston Orthopaedics||no longer recruiting|
|Pittsburgh, PA||University of Pittsburgh||no longer recruiting|
|Sioux Falls, SD||Orthopaedic Institute||no longer recruiting|
|Knoxville, TN||Southeastern Orthopaedics / Knoxville Orthopaedic Clinic||no longer recruiting|
|Nashville, TN||Tennessee Orthopaedic Alliance||no longer recruiting|
|Nashville, TN||Vanderbilt University||no longer recruiting|
|Dallas, TX||W.B. Carroll Memorial Clinic||no longer recruiting|
|Burlington, VT||University of Vermont College of Medicine||no longer recruiting|
|Lansdowne, VA||National Sports Medicine Institute||no longer recruiting|
|Reston, VA||Town Center Orthopaedic Associates||no longer recruiting|
|Vienna, VA||Commonwealth Orthopaedics and Rehabilitation||no longer recruiting|
|Pullman, WA||Inland Orthopaedics/Washington State University||no longer recruiting|
|New Westminster, Canada||Royal Columbian Hospital (FraserHealth)||no longer recruiting|
|London, Canada||Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario||no longer recruiting|
time frame: 2, 6, and 10 years after revision ACL surgery
Patient based outcome measures
time frame: 2, 6, and 10 years after revision ACL surgery
Male or female participants from 12 years up to 65 years old.
- 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.
|Official title||Multicenter ACL Revision Study (MARS)|
|Principal investigator||Rick W. Wright, M.D.|
|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.|
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