Multicenter ACL Revision Study (MARS)

Sponsor

Vanderbilt University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00625885

Collaborator

Vanderbilt University Medical Center (Other), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)

1,234

Enrollment

Locations

214

Duration (Months)

25.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Actual Enrollment :

1234 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Multicenter ACL Revision Study (MARS)

Study Start Date :

Feb 1, 2007

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Graft re-rupture [2, 6, and 10 years after revision ACL surgery]

Secondary Outcome Measures

Patient based outcome measures [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

Criteria

Ages Eligible for Study:

12 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Scripps Memorial Hospital (OrthoCal Healthcare)	La Jolla	California	United States	92123
2	University of California - Los Angeles (UCLA)	Los Angeles	California	United States	90095
3	University of California - San Francisco	San Francisco	California	United States	94143
4	Orthopaedic Associates of Aspen and Glenwood	Aspen	Colorado	United States	81611
5	University of Colorado	Boulder	Colorado	United States	80304
6	Connecticut Children's Medical Center	Farmington	Connecticut	United States	06032
7	University of Connecticut Health Center	Farmington	Connecticut	United States	06034
8	UHZ Sports Medicine Institute	Coral Gables	Florida	United States	33146
9	Intermountain Orthopaedics	Boise	Idaho	United States	83703
10	Rush University Medical Center	Chicago	Illinois	United States	60612
11	Methodist Sports Medicine Center	Indianapolis	Indiana	United States	46280
12	University of Iowa	Iowa City	Iowa	United States	52242
13	Cheaspeake Orthopaedics and Sports Medicine Center	Glen Burnie	Maryland	United States	21061
14	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
15	University of Michigan	Ann Arbor	Michigan	United States	48106
16	Mayo Clinic	Rochester	Minnesota	United States	55905
17	Regions Hospital (Health Partners Research Foundation)	Saint Paul	Minnesota	United States	55101
18	Washington University at St. Louis	Saint Louis	Missouri	United States	63141
19	Bridger Orthopaedic and Sports Medicine	Bozeman	Montana	United States	59715
20	New Hamphsire Knee Center	Holderness	New Hampshire	United States	03217
21	Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08901
22	Princeton Orthopaedic Associates	Princeton	New Jersey	United States	08540
23	University of Buffalo	Buffalo	New York	United States	14214
24	NYU School of Medicine	New York	New York	United States	10016
25	Hospital for Special Surgery	New York	New York	United States	10021
26	Manhattan Orthopaedics, P.C.	New York	New York	United States	10021
27	Keller Army Community Hospital - USMA	West Point	New York	United States	10996
28	University of North Carolina Medical Center	Chapel Hill	North Carolina	United States	27599
29	Perry Orthopaedics and Sports Med (Carolinas Healthcare System)	Charlotte	North Carolina	United States	28211
30	Duke University	Durham	North Carolina	United States	27710
31	Cleveland Clinic	Cleveland	Ohio	United States	44195
32	The Ohio State University	Columbus	Ohio	United States	43221
33	Slocum Research and Education Foundation	Eugene	Oregon	United States	97401
34	Orthopaedic and Fracture Clinic	Portland	Oregon	United States	97225
35	The Rothman Institute / Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19085
36	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
37	Booth, Bartolozzi, Balderston Orthopaedics	Philadelphia	Pennsylvania	United States	19107
38	Orthopaedic Institute	Sioux Falls	South Dakota	United States	57115
39	Southeastern Orthopaedics / Knoxville Orthopaedic Clinic	Knoxville	Tennessee	United States	37909
40	Vanderbilt University	Nashville	Tennessee	United States	37232
41	W.B. Carroll Memorial Clinic	Dallas	Texas	United States	75204
42	San Antonio Orthopaedic Group	San Antonio	Texas	United States	78216
43	University of Vermont College of Medicine	Burlington	Vermont	United States	05405
44	National Sports Medicine Institute	Lansdowne Town Center	Virginia	United States	20176
45	Town Center Orthopaedic Associates	Reston	Virginia	United States	20190
46	Commonwealth Orthopaedics and Rehabilitation	Vienna	Virginia	United States	22181
47	Inland Orthopaedics/Washington State University	Pullman	Washington	United States	99163
48	Royal Columbian Hospital (FraserHealth)	New Westminster	British Columbia	Canada	V3L3W7
49	Fowler Kennedy Sports Medicine Clinic/Univ. of Western Ontario	London	Ontario	Canada

Sponsors and Collaborators

Vanderbilt University
Vanderbilt University Medical Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator: Rick W. Wright, M.D., Vanderbilt University Medical Center
Principal Investigator: Kurt P. Spindler, M.D., Vanderbilt University Medical Center