We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Multicenter ACL Revision Study (MARS) (MARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00625885
Recruitment Status : Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : November 30, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Rupture of Anterior Cruciate Ligament

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 Design

Study Type : Observational
Estimated Enrollment : 1250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter ACL Revision Study (MARS)
Study Start Date : February 2007
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Graft re-rupture [ Time Frame: 2, 6, and 10 years after revision ACL surgery ]

Secondary Outcome Measures :
  1. 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).

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625885

  Show 52 Study Locations
Sponsors and Collaborators
Vanderbilt University
Vanderbilt University Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Rick W. Wright, M.D. Washington University School of Medicine
Principal Investigator: Kurt P. Spindler, M.D. Vanderbilt University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kurt P. Spindler, Adjoint Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00625885     History of Changes
Other Study ID Numbers: 070110
R01AR060846 ( U.S. NIH Grant/Contract )
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kurt P. Spindler, Vanderbilt University:
Anterior Cruciate Ligament/injuries
Anterior Cruciate Ligament/surgery
Knee injuries/surgery
Outcomes research
Prospective Studies

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Wounds and Injuries
Knee Injuries
Leg Injuries