Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

Completed

• Conditions: Rupture of Anterior Cruciate Ligament

• Registration Number: NCT00463099
• Lead Sponsor: Vanderbilt University Medical Center

Brief Summary

The purpose of this study is to determine the effect of modifiable risk factors on knee function, osteoarthritis, and re-rupture of the anterior cruciate ligament (ACL) following ACL reconstruction.

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 2-10 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 2-10 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 Timeline

• Study Start: 2002-01
• Study First Submitted: 2007-04-19
• Study First Submitted QC: 2007-04-19
• Study First Posted: 2007-04-20
• Primary Completion: 2021-05
• Study Completion: 2021-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3294

Inclusion Criteria

• All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.
• Between 10 and 33 years of age
• Injured while playing a sport
• Normal contralateral leg (no previous surgeries)

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Exclusion Criteria

• Persons undergoing a simultaneous bilateral ACL reconstruction
• Patients less than 10 years old and older than 33 years old
• patients not injured while playing a sport (e.g., MVA, ADL)
• Patients unwilling or unable to complete their repeat questionnaire 2, 6, and 10 years after their initial visit.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
patient-reported outcome measures	2, 6, and 10 years	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).

Secondary Outcome Measures

Name	Time	Method
Signs and symptoms of osteoarthritis	2, 6, and 10 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).

Trial Locations

Locations (8)

Washington University at St. Louis; 🇺🇸 Saint Louis, Missouri, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Colorado; 🇺🇸 Boulder, Colorado, United States

Duke University; 🇺🇸 Durham, North Carolina, United States