Clinical trial NCT00463099: Multicenter Orthopaedics Outcomes Network for ACL Reconstructions
Official title: Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: Anterior Cruciate Ligament/injuries
Anterior Cruciate Ligament/surgery
Knee injuries/surgery
Outcomes research
Prospective Studies
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2007-04-20
Enrollment: 3294
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.

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.

Eligibility criteria: 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

Primary outcomes:
measure: patient-reported outcome measures
timeFrame: 2, 6, 10, and 20 years
Secondary outcomes:
measure: Signs and symptoms of osteoarthritis
timeFrame: 2, 6, 10, and 20 years
Other outcomes:
measure: ACL graft failure
timeFrame: 2, 6, 10, and 20 years
Locations:
city: Boulder
country: United States
facility: University of Colorado
state: Colorado
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Saint Louis
country: United States
facility: Washington University at St. Louis
state: Missouri
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Kurt P. Spindler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.