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Multicenter ACL Revision Study (MARS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00625885
First received: February 19, 2008
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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
Anterior Cruciate Ligament

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter ACL Revision Study (MARS)

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Graft re-rupture [ Time Frame: 2 and 6 years after revision surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient based outcome measures [ Time Frame: 2 and 6 years after revision surgery ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 1250
Study Start Date: February 2007
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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 two-year follow-up. 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 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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625885

  Show 50 Study Locations
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Rick W. Wright, M.D. Washington University School of Medicine
Principal Investigator: Kurt P. Spindler, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00625885     History of Changes
Other Study ID Numbers: 070110, R01AR060846
Study First Received: February 19, 2008
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Anterior Cruciate Ligament/injuries
Anterior Cruciate Ligament/surgery
Knee injuries/surgery
Outcomes research
Prospective Studies

ClinicalTrials.gov processed this record on November 27, 2014