Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

NCT ID: NCT00463099

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3294 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-01-31

Study Completion Date

2028-12-31

Brief Summary

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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

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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.

Conditions

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Rupture of Anterior Cruciate Ligament

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kurt P. Spindler

Adjoint Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kurt P. Spindler, M.D.

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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University of Colorado

Boulder, Colorado, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Washington University at St. Louis

St Louis, Missouri, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34541016 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33945339 (View on PubMed)

Other Identifiers

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R01AR053684

Identifier Type: NIH

Identifier Source: secondary_id

View Link

990426

Identifier Type: -

Identifier Source: org_study_id

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