Multicenter ACL Revision Study (MARS)

Rupture of Anterior Cruciate Ligament Clinical Trial

— MARS  

Official title:

Multicenter ACL Revision Study (MARS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00625885
• Other study ID #: 070110
• Secondary ID: R01AR060846
• Status: Active, not recruiting
• Start date: February 2007
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 1234
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario	London	Ontario
Canada	Royal Columbian Hospital (FraserHealth)	New Westminster	British Columbia
United States	University of Michigan	Ann Arbor	Michigan
United States	Orthopaedic Associates of Aspen and Glenwood	Aspen	Colorado
United States	Intermountain Orthopaedics	Boise	Idaho
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Colorado	Boulder	Colorado
United States	Bridger Orthopaedic and Sports Medicine	Bozeman	Montana
United States	University of Buffalo	Buffalo	New York
United States	University of Vermont College of Medicine	Burlington	Vermont
United States	University of North Carolina Medical Center	Chapel Hill	North Carolina
United States	Perry Orthopaedics and Sports Med (Carolinas Healthcare System)	Charlotte	North Carolina
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University	Columbus	Ohio
United States	UHZ Sports Medicine Institute	Coral Gables	Florida
United States	W.B. Carroll Memorial Clinic	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	Slocum Research and Education Foundation	Eugene	Oregon
United States	Connecticut Children's Medical Center	Farmington	Connecticut
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Cheaspeake Orthopaedics and Sports Medicine Center	Glen Burnie	Maryland
United States	New Hamphsire Knee Center	Holderness	New Hampshire
United States	Methodist Sports Medicine Center	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Southeastern Orthopaedics / Knoxville Orthopaedic Clinic	Knoxville	Tennessee
United States	Scripps Memorial Hospital (OrthoCal Healthcare)	La Jolla	California
United States	National Sports Medicine Institute	Lansdowne Town Center	Virginia
United States	University of California - Los Angeles (UCLA)	Los Angeles	California
United States	Vanderbilt University	Nashville	Tennessee
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Hospital for Special Surgery	New York	New York
United States	Manhattan Orthopaedics, P.C.	New York	New York
United States	NYU School of Medicine	New York	New York
United States	Booth, Bartolozzi, Balderston Orthopaedics	Philadelphia	Pennsylvania
United States	The Rothman Institute / Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Orthopaedic and Fracture Clinic	Portland	Oregon
United States	Princeton Orthopaedic Associates	Princeton	New Jersey
United States	Inland Orthopaedics/Washington State University	Pullman	Washington
United States	Town Center Orthopaedic Associates	Reston	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Washington University at St. Louis	Saint Louis	Missouri
United States	Regions Hospital (Health Partners Research Foundation)	Saint Paul	Minnesota
United States	San Antonio Orthopaedic Group	San Antonio	Texas
United States	University of California - San Francisco	San Francisco	California
United States	Orthopaedic Institute	Sioux Falls	South Dakota
United States	Commonwealth Orthopaedics and Rehabilitation	Vienna	Virginia
United States	Keller Army Community Hospital - USMA	West Point	New York

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Vanderbilt University Medical Center

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft re-rupture		2, 6, and 10 years after revision ACL surgery
Secondary	Patient based outcome measures	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).	2, 6, and 10 years after revision ACL surgery