Multicenter ACL Revision Study (MARS) (MARS)

February 19, 2024 updated by: Kurt P. Spindler, Vanderbilt University

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L3W7
        • Royal Columbian Hospital (FraserHealth)
    • Ontario
      • London, Ontario, Canada
        • Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario
  • United States
    • California
      • La Jolla, California, United States, 92123
        • Scripps Memorial Hospital (OrthoCal Healthcare)
      • Los Angeles, California, United States, 90095
        • University of California - Los Angeles (UCLA)
      • San Francisco, California, United States, 94143
        • University of California - San Francisco
    • Colorado
      • Aspen, Colorado, United States, 81611
        • Orthopaedic Associates of Aspen and Glenwood
      • Boulder, Colorado, United States, 80304
        • University of Colorado
    • Connecticut
      • Farmington, Connecticut, United States, 06034
        • University of Connecticut Health Center
      • Farmington, Connecticut, United States, 06032
        • Connecticut Children's Medical Center
    • Florida
      • Coral Gables, Florida, United States, 33146
        • UHZ Sports Medicine Institute
    • Idaho
      • Boise, Idaho, United States, 83703
        • Intermountain Orthopaedics
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46280
        • Methodist Sports Medicine Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Cheaspeake Orthopaedics and Sports Medicine Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital (Health Partners Research Foundation)
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Washington University at St. Louis
    • Montana
      • Bozeman, Montana, United States, 59715
        • Bridger Orthopaedic and Sports Medicine
    • New Hampshire
      • Holderness, New Hampshire, United States, 03217
        • New Hamphsire Knee Center
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
      • Princeton, New Jersey, United States, 08540
        • Princeton Orthopaedic Associates
    • New York
      • Buffalo, New York, United States, 14214
        • University of Buffalo
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10016
        • NYU School of Medicine
      • New York, New York, United States, 10021
        • Manhattan Orthopaedics, P.C.
      • West Point, New York, United States, 10996
        • Keller Army Community Hospital - USMA
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Medical Center
      • Charlotte, North Carolina, United States, 28211
        • Perry Orthopaedics and Sports Med (Carolinas Healthcare System)
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43221
        • The Ohio State University
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Slocum Research and Education Foundation
      • Portland, Oregon, United States, 97225
        • Orthopaedic and Fracture Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19085
        • The Rothman Institute / Thomas Jefferson University
      • Philadelphia, Pennsylvania, United States, 19107
        • Booth, Bartolozzi, Balderston Orthopaedics
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57115
        • Orthopaedic Institute
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Orthopaedics / Knoxville Orthopaedic Clinic
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Texas
      • Dallas, Texas, United States, 75204
        • W.B. Carroll Memorial Clinic
      • San Antonio, Texas, United States, 78216
        • San Antonio Orthopaedic Group
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont College of Medicine
    • Virginia
      • Lansdowne Town Center, Virginia, United States, 20176
        • National Sports Medicine Institute
      • Reston, Virginia, United States, 20190
        • Town Center Orthopaedic Associates
      • Vienna, Virginia, United States, 22181
        • Commonwealth Orthopaedics and Rehabilitation
    • Washington
      • Pullman, Washington, United States, 99163
        • Inland Orthopaedics/Washington State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All ACL-deficient candidates scheduled for a revision ACL reconstruction at one of the participating MARS sites.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft re-rupture
Time Frame: 2, 6, and 10 years after revision ACL surgery
2, 6, and 10 years after revision ACL surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient based outcome measures
Time Frame: 2, 6, and 10 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).
2, 6, and 10 years after revision ACL surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Rick W. Wright, M.D., Vanderbilt University Medical Center
  • Principal Investigator: Kurt P. Spindler, M.D., Vanderbilt University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

February 19, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimated)

February 28, 2008

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070110
  • R01AR060846 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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