Multicenter ACL Revision Study (MARS)

NCT00625885 | Active Not Recruiting

• 2 other identifiers: 070110R01AR060846
• Study Type: observational
• Target: 1,234
• Locations: 2 countries
• Sites: 49

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.

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior Cruciate Ligament/injuries; Anterior Cruciate Ligament/surgery; Knee injuries/surgery; Outcomes research; Prospective Studies

Outcome Measures

Primary Outcomes (1)

• Graft re-rupture

  2, 6, 10, and 20 years after revision ACL surgery

Secondary Outcomes (1)

• Patient based outcome measures

  2, 6,10, and 20 years after revision ACL surgery

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Vanderbilt University Medical Center: collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (49)

Scripps Memorial Hospital (OrthoCal Healthcare)

La Jolla, California, 92123, United States

Location

University of California - Los Angeles (UCLA)

Los Angeles, California, 90095, United States

Location

University of California - San Francisco

San Francisco, California, 94143, United States

Location

Orthopaedic Associates of Aspen and Glenwood

Aspen, Colorado, 81611, United States

Location

University of Colorado

Boulder, Colorado, 80304, United States

Location

Connecticut Children's Medical Center

Farmington, Connecticut, 06032, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06034, United States

Location

UHZ Sports Medicine Institute

Coral Gables, Florida, 33146, United States

Location

Intermountain Orthopaedics

Boise, Idaho, 83703, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Methodist Sports Medicine Center

Indianapolis, Indiana, 46280, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Cheaspeake Orthopaedics and Sports Medicine Center

Glen Burnie, Maryland, 21061, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Regions Hospital (Health Partners Research Foundation)

Saint Paul, Minnesota, 55101, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63141, United States

Location

Bridger Orthopaedic and Sports Medicine

Bozeman, Montana, 59715, United States

Location

New Hamphsire Knee Center

Holderness, New Hampshire, 03217, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

Princeton Orthopaedic Associates

Princeton, New Jersey, 08540, United States

Location

University of Buffalo

Buffalo, New York, 14214, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Manhattan Orthopaedics, P.C.

New York, New York, 10021, United States

Location

Keller Army Community Hospital - USMA

West Point, New York, 10996, United States

Location

University of North Carolina Medical Center

Chapel Hill, North Carolina, 27599, United States

Location

Perry Orthopaedics and Sports Med (Carolinas Healthcare System)

Charlotte, North Carolina, 28211, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Slocum Research and Education Foundation

Eugene, Oregon, 97401, United States

Location

Orthopaedic and Fracture Clinic

Portland, Oregon, 97225, United States

Location

The Rothman Institute / Thomas Jefferson University

Philadelphia, Pennsylvania, 19085, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Booth, Bartolozzi, Balderston Orthopaedics

Philadelphia, Pennsylvania, 19107, United States

Location

Orthopaedic Institute

Sioux Falls, South Dakota, 57115, United States

Location

Southeastern Orthopaedics / Knoxville Orthopaedic Clinic

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

W.B. Carroll Memorial Clinic

Dallas, Texas, 75204, United States

Location

San Antonio Orthopaedic Group

San Antonio, Texas, 78216, United States

Location

University of Vermont College of Medicine

Burlington, Vermont, 05405, United States

Location

National Sports Medicine Institute

Lansdowne, Virginia, 20176, United States

Location

Town Center Orthopaedic Associates

Reston, Virginia, 20190, United States

Location

Commonwealth Orthopaedics and Rehabilitation

Vienna, Virginia, 22181, United States

Location

Inland Orthopaedics/Washington State University

Pullman, Washington, 99163, United States

Location

Royal Columbian Hospital (FraserHealth)

New Westminster, British Columbia, V3L3W7, Canada

Location

Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario

London, Ontario, Canada

Location

Related Publications (3)

• 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.

  PMID: 39555321 DERIVED

• 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.

  PMID: 29882693 DERIVED

• 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.

  PMID: 27161867 DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries; Knee Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Rick W. Wright, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Kurt P. Spindler, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjoint Professor

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: March 26, 2006
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (47)