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Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00463099
Enrollment
3294
Registered
2007-04-20
Start date
2002-01-01
Completion date
2028-12-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

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

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 2-20 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.

Interventions

None listed

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
CollaboratorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
patient-reported outcome measures2, 6, 10, and 20 yearsSports 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

MeasureTime frameDescription
Signs and symptoms of osteoarthritis2, 6, 10, and 20 yearsSigns of OA (as measured by joint space narrowing on a standing radiograph). Symptoms of OA (as measured by WOMAC and KOOS pain subscales).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKurt P. Spindler, M.D.

Vanderbilt University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026