NCT00463099

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,294

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Jan 2002

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jan 2002Dec 2028

Study Start

First participant enrolled

January 1, 2002

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2007

Completed
20.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

25.9 years

First QC Date

April 19, 2007

Last Update Submit

January 25, 2026

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior Cruciate Ligament/injuriesAnterior Cruciate Ligament/surgeryKnee injuries/surgeryOutcomes researchProspective Studies

Outcome Measures

Primary Outcomes (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).

    2, 6, 10, and 20 years

Secondary Outcomes (1)

  • Signs and symptoms of osteoarthritis

    2, 6, 10, and 20 years

Other Outcomes (1)

  • ACL graft failure

    2, 6, 10, and 20 years

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Colorado

Boulder, Colorado, 80304, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Washington University at St. Louis

St Louis, Missouri, 63141, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • 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.

    PMID: 34541016DERIVED

  • 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.

    PMID: 33945339DERIVED

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Kurt P. Spindler, M.D.

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjoint Professor

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 20, 2007

Study Start

January 1, 2002

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(8)