Clinical trial NCT00625885: Multicenter ACL Revision Study (MARS)
Official title: Multicenter ACL Revision Study (MARS)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: Anterior Cruciate Ligament/injuries
Anterior Cruciate Ligament/surgery
Knee injuries/surgery
Outcomes research
Prospective Studies
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2008-02-28
Enrollment: 1234
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All ACL-deficient candidates scheduled for a revision ACL reconstruction at one of the participating MARS sites.

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.

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.

Primary outcomes:
measure: Graft re-rupture
timeFrame: 2, 6, 10, and 20 years after revision ACL surgery
Secondary outcomes:
measure: Patient based outcome measures
timeFrame: 2, 6,10, and 20 years after revision ACL surgery
Other outcomes:
Locations:
city: LaJolla
country: United States
facility: Scripps Memorial Hospital (OrthoCal Healthcare)
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles (UCLA)
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
city: Aspen
country: United States
facility: Orthopaedic Associates of Aspen and Glenwood
state: Colorado
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
city: Farmington
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Coral Gables
country: United States
facility: UHZ Sports Medicine Institute
state: Florida
city: Boise
country: United States
facility: Intermountain Orthopaedics
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Methodist Sports Medicine Center
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Glen Burnie
country: United States
facility: Cheaspeake Orthopaedics and Sports Medicine Center
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital (Health Partners Research Foundation)
state: Minnesota
city: St. Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: Bozeman
country: United States
facility: Bridger Orthopaedic and Sports Medicine
state: Montana
city: Holderness
country: United States
facility: New Hamphsire Knee Center
state: New Hampshire
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Princeton
country: United States
facility: Princeton Orthopaedic Associates
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: New York
country: United States
facility: NYU School of Medicine
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: New York
country: United States
facility: Manhattan Orthopaedics, P.C.
state: New York
city: West Point
country: United States
facility: Keller Army Community Hospital - USMA
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Medical Center
state: North Carolina
city: Charlotte
country: United States
facility: Perry Orthopaedics and Sports Med (Carolinas Healthcare System)
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Eugene
country: United States
facility: Slocum Research and Education Foundation
state: Oregon
city: Portland
country: United States
facility: Orthopaedic and Fracture Clinic
state: Oregon
city: Philadelphia
country: United States
facility: The Rothman Institute / Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Booth, Bartolozzi, Balderston Orthopaedics
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Orthopaedic Institute
state: South Dakota
city: Knoxville
country: United States
facility: Southeastern Orthopaedics / Knoxville Orthopaedic Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: W.B. Carroll Memorial Clinic
state: Texas
city: San Antonio
country: United States
facility: San Antonio Orthopaedic Group
state: Texas
city: Burlington
country: United States
facility: University of Vermont College of Medicine
state: Vermont
city: Lansdowne
country: United States
facility: National Sports Medicine Institute
state: Virginia
city: Reston
country: United States
facility: Town Center Orthopaedic Associates
state: Virginia
city: Vienna
country: United States
facility: Commonwealth Orthopaedics and Rehabilitation
state: Virginia
city: Pullman
country: United States
facility: Inland Orthopaedics/Washington State University
state: Washington
city: New Westminster
country: Canada
facility: Royal Columbian Hospital (FraserHealth)
state: British Columbia
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario
state: Ontario
Study officials:
affiliation: Vanderbilt University Medical Center
name: Rick W. Wright, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Kurt P. Spindler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.