Multicenter Orthopaedics Outcomes Network for ACL Reconstructions
Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study
Study Overview
Status
Conditions
Detailed Description
Disruption of the anterior cruciate ligament (ACL) is among the most frequent musculoskeletal injuries affecting physically active men and women. An estimated 200,000 ACL reconstructions (ACLR) are performed annually, and the incidence of this injury is roughly 1 in 3000 per year. ACL injury has both immediate and long-term implications for an injured person's quality of life, their risk for osteoarthritis (OA), and long-term disability. Currently, ACLR is recommended as the standard of care following an ACL tear based on evidence for improved instrumented laxity, the desire to return to sports play, and evidence for a reduction in future knee injuries.
In this research we propose to identify risk factors measurable at the time of injury/surgery in order to estimate the magnitude of the effect of these factors on important quality of life and clinical outcomes (e.g.,OA and incidence of additional surgery) 2 to 10 years after a patient's ACL reconstruction.
AIM 1. To identify risk factors for reduced quality of life 2-20 yrs post-ACLR, from information available at the time of surgery; including the characteristics of the patients (age, gender, body mass index, activity level, clinical knee alignment) and their injuries (concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g., graft choice, meniscus and articular cartilage treatments).
AIM 2. To identify risk factors for symptoms and signs of osteoarthritis 2-20 years post-ACLR, from information available at the time of surgery; including the characteristics of the patients (as above) and their injuries (as above), and treatment decisions made during ACLR (as above).
AIM 3. To identify risk factors for recurrent ligament disruption and additional arthroscopic knee surgeries of the ACLR knee, from among the characteristics of the patients (as above), their initial injuries (as above), and treatment decisions made during ACLR (as above).
The overarching goal of this study is to establish evidence-based medicine practices of counseling patients on prognosis, guiding surgeons on treatment of meniscus and articular cartilage injuries, and post-surgical care, as well as the appropriate evidence for future interventional trials in the targeted subset of ACLRs with poorer outcomes.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Colorado
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Boulder, Colorado, United States, 80304
- University of Colorado
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Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa
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Missouri
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St Louis, Missouri, United States, 63141
- Washington University at St. Louis
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Columbus, Ohio, United States, 43221
- The Ohio State University
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.
Exclusion Criteria:
- Persons undergoing a simultaneous bilateral ACL reconstruction
- Patients less than 10 years old and older than 80 years old
- Patients unwilling or unable to complete their follow-up questionnaire
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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patient-reported outcome measures
Time Frame: 2, 6, 10, and 20 years
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Sports function (as measured by the KOOS and IKDC).
Activity level (as measured by the Marx activity rating scale).
General health (as measured by the SF-36).
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2, 6, 10, and 20 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Signs and symptoms of osteoarthritis
Time Frame: 2, 6, 10, and 20 years
|
Signs of OA (as measured by joint space narrowing on a standing radiograph).
Symptoms of OA (as measured by WOMAC and KOOS pain subscales).
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2, 6, 10, and 20 years
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Other Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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ACL graft failure
Time Frame: 2, 6, 10, and 20 years
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2, 6, 10, and 20 years
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kurt P. Spindler, M.D., Vanderbilt University
Publications and helpful links
General Publications
- Marmura H, Getgood AMJ, Spindler KP, Kattan MW, Briskin I, Bryant DM. Validation of a Risk Calculator to Personalize Graft Choice and Reduce Rupture Rates for Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2021 Jun;49(7):1777-1785. doi: 10.1177/03635465211010798. Epub 2021 May 4.
- Salem HS, Huston LJ, Zajichek A, McCarty EC, Vidal AF, Bravman JT, Spindler KP, Frank RM; MOON Knee Group; Amendola A, Andrish JT, Brophy RH, Jones MH, Kaeding CC, Marx RG, Matava MJ, Parker RD, Wolcott ML, Wolf BR, Wright RW. Anterior Cruciate Ligament Reconstruction With Concomitant Meniscal Repair: Is Graft Choice Predictive of Meniscal Repair Success? Orthop J Sports Med. 2021 Sep 14;9(9):23259671211033584. doi: 10.1177/23259671211033584. eCollection 2021 Sep.
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 990426
- R01AR053684 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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