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Rupture of Anterior Cruciate LigamentNCT00463099

Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

An observational study of Rupture of Anterior Cruciate Ligament, run by Vanderbilt University Medical Center at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 80 years
Conditions the study is for
Rupture of Anterior Cruciate Ligament
How many people
3,294 participants
Where
8 sitesUnited States
Study dates
Jan 2002to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All eligible ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.

Who may be able to join

  • All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.

Who cannot join

  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University of Colorado

    Boulder, Colorado, 80304

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • The Ohio State University

    Columbus, Ohio, 43221

  • Duke University

    Durham, North Carolina, 27710

  • University of Iowa

    Iowa City, Iowa, 52242

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Hospital for Special Surgery

    New York, New York, 10021

  • Washington University at St. Louis

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study

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.

Read the 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.

Keywords
Anterior Cruciate Ligament/injuries, Anterior Cruciate Ligament/surgery, Knee injuries/surgery, Outcomes research, Prospective Studies
Medical subject headings
Anterior Cruciate Ligament Injuries, Knee Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. patient-reported outcome measures

    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).

    Measured: 2, 6, 10, and 20 years

Secondary outcomes (1)

  1. Signs and symptoms of osteoarthritis

    Signs of OA (as measured by joint space narrowing on a standing radiograph). Symptoms of OA (as measured by WOMAC and KOOS pain subscales).

    Measured: 2, 6, 10, and 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2007 (estimated)
  2. Study startJan 2002
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,294 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00463099
Sponsor's protocol ID
990426
Other IDs
R01AR053684
Status last verified
Aug 2026
First submitted
19 Apr 2007
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34541016

  • 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.

    PubMed 33945339

Questions about this trial

What is this clinical trial studying?

An observational study of Rupture of Anterior Cruciate Ligament, run by Vanderbilt University Medical Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient-reported outcome measures (time frame: 2, 6, 10, and 20 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00463099, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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