Multicenter ACL Revision Study (MARS)

NCT ID: NCT00625885

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1234 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-03-26
• Study Completion Date: 2029-08-31

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.

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, 6,10 and 20 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 knee osteoarthritis at up to 20 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.

Conditions

Rupture of Anterior Cruciate Ligament

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Kurt P. Spindler

Adjoint Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rick W. Wright, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Kurt P. Spindler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Scripps Memorial Hospital (OrthoCal Healthcare)

La Jolla, California, United States

University of California - Los Angeles (UCLA)

Los Angeles, California, United States

University of California - San Francisco

San Francisco, California, United States

Orthopaedic Associates of Aspen and Glenwood

Aspen, Colorado, United States

University of Colorado

Boulder, Colorado, United States

Connecticut Children's Medical Center

Farmington, Connecticut, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

UHZ Sports Medicine Institute

Coral Gables, Florida, United States

Intermountain Orthopaedics

Boise, Idaho, United States

Rush University Medical Center

Chicago, Illinois, United States

Methodist Sports Medicine Center

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

Cheaspeake Orthopaedics and Sports Medicine Center

Glen Burnie, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Regions Hospital (Health Partners Research Foundation)

Saint Paul, Minnesota, United States

Washington University at St. Louis

St Louis, Missouri, United States

Bridger Orthopaedic and Sports Medicine

Bozeman, Montana, United States

New Hamphsire Knee Center

Holderness, New Hampshire, United States

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Princeton Orthopaedic Associates

Princeton, New Jersey, United States

University of Buffalo

Buffalo, New York, United States

NYU School of Medicine

New York, New York, United States

Hospital for Special Surgery

New York, New York, United States

Manhattan Orthopaedics, P.C.

New York, New York, United States

Keller Army Community Hospital - USMA

West Point, New York, 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

Duke University

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Slocum Research and Education Foundation

Eugene, Oregon, United States

Orthopaedic and Fracture Clinic

Portland, Oregon, United States

The Rothman Institute / Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Booth, Bartolozzi, Balderston Orthopaedics

Philadelphia, Pennsylvania, United States

Orthopaedic Institute

Sioux Falls, South Dakota, United States

Southeastern Orthopaedics / Knoxville Orthopaedic Clinic

Knoxville, Tennessee, United States

Vanderbilt University

Nashville, Tennessee, United States

W.B. Carroll Memorial Clinic

Dallas, Texas, United States

San Antonio Orthopaedic Group

San Antonio, Texas, United States

University of Vermont College of Medicine

Burlington, Vermont, United States

National Sports Medicine Institute

Lansdowne, Virginia, United States

Town Center Orthopaedic Associates

Reston, Virginia, United States

Commonwealth Orthopaedics and Rehabilitation

Vienna, Virginia, United States

Inland Orthopaedics/Washington State University

Pullman, Washington, United States

Royal Columbian Hospital (FraserHealth)

New Westminster, British Columbia, Canada

Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario

London, Ontario, Canada

Countries

United States; Canada

References

MARS Group; Vasavada K, Vasavada V, Moran J, Devana S, Lee C, Hame SL, Jazrawi LM, Sherman OH, Huston LJ, Haas AK, Allen CR, Cooper DE, DeBerardino TM, Spindler KP, Stuart MJ, Ned Amendola A, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, David TS, Dunn WR, Flanigan DC, Frederick RW, Ganley TJ, Gatt CJ Jr, Gecha SR, Giffin JR, Hannafin JA, Lindsay Harris N Jr, Hechtman KS, Hershman EB, Hoellrich RG, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, Wright RW, York JJ. A Novel Machine Learning Model to Predict Revision ACL Reconstruction Failure in the MARS Cohort. Orthop J Sports Med. 2024 Nov 14;12(11):23259671241291920. doi: 10.1177/23259671241291920. eCollection 2024 Nov.

Reference Type: DERIVED

PMID: 39555321 (View on PubMed)

MARS Group; Cooper DE, Dunn WR, Huston LJ, Haas AK, Spindler KP, Allen CR, Anderson AF, DeBerardino TM, Lantz BBA, Mann B, Stuart MJ, Albright JP, Amendola AN, Andrish JT, Annunziata CC, Arciero RA, Bach BR Jr, Baker CL 3rd, Bartolozzi AR, Baumgarten KM, Bechler JR, Berg JH, Bernas GA, Brockmeier SF, Brophy RH, Bush-Joseph CA, Butler V JB, Campbell JD, Carey JL, Carpenter JE, Cole BJ, Cooper JM, Cox CL, Creighton RA, Dahm DL, David TS, Flanigan DC, Frederick RW, Ganley TJ, Garofoli EA, Gatt CJ Jr, Gecha SR, Giffin JR, Hame SL, Hannafin JA, Harner CD, Harris NL Jr, Hechtman KS, Hershman EB, Hoellrich RG, Hosea TM, Johnson DC, Johnson TS, Jones MH, Kaeding CC, Kamath GV, Klootwyk TE, Levy BA, Ma CB, Maiers GP 2nd, Marx RG, Matava MJ, Mathien GM, McAllister DR, McCarty EC, McCormack RG, Miller BS, Nissen CW, O'Neill DF, Owens BD, Parker RD, Purnell ML, Ramappa AJ, Rauh MA, Rettig AC, Sekiya JK, Shea KG, Sherman OH, Slauterbeck JR, Smith MV, Spang JT, Svoboda SJ, Taft TN, Tenuta JJ, Tingstad EM, Vidal AF, Viskontas DG, White RA, Williams JS Jr, Wolcott ML, Wolf BR, York JJ, Wright RW. Physiologic Preoperative Knee Hyperextension Is a Predictor of Failure in an Anterior Cruciate Ligament Revision Cohort: A Report From the MARS Group. Am J Sports Med. 2018 Oct;46(12):2836-2841. doi: 10.1177/0363546518777732. Epub 2018 Jun 8.

Reference Type: DERIVED

PMID: 29882693 (View on PubMed)

MARS Group. Meniscal and Articular Cartilage Predictors of Clinical Outcome After Revision Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2016 Jul;44(7):1671-9. doi: 10.1177/0363546516644218. Epub 2016 May 9.

Reference Type: DERIVED

PMID: 27161867 (View on PubMed)

Other Identifiers

R01AR060846

Identifier Type: NIH

Identifier Source: secondary_id

View Link

070110

Identifier Type: -

Identifier Source: org_study_id