Multicenter Orthopaedics Outcomes Network for ACL Reconstructions
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|ClinicalTrials.gov Identifier: NCT00463099|
Recruitment Status : Active, not recruiting
First Posted : April 20, 2007
Last Update Posted : November 30, 2017
|Condition or disease|
|Rupture of Anterior Cruciate Ligament|
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 2-10 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 2-10 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.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study|
|Study Start Date :||January 2002|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
- patient-reported outcome measures [ Time Frame: 2, 6, and 10 years ]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).
- Signs and symptoms of osteoarthritis [ Time Frame: 2, 6, and 10 years ]Signs of OA (as measured by joint space narrowing on a standing radiograph). Symptoms of OA (as measured by WOMAC and KOOS pain subscales).
- ACL graft failure [ Time Frame: 2, 6, and 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00463099
|United States, Colorado|
|University of Colorado|
|Boulder, Colorado, United States, 80304|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Massachusetts|
|Boston Children's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Washington University at St. Louis|
|Saint Louis, Missouri, United States, 63141|
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|The Ohio State University|
|Columbus, Ohio, United States, 43221|
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Kurt P. Spindler, M.D.||Vanderbilt University|