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| Sponsor: | Vanderbilt University |
|---|---|
| Collaborator: |
National Institutes of Health (NIH) |
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00463099 |
Purpose
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.
| Condition |
|---|
|
Anterior Cruciate Ligament |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study |
| Estimated Enrollment: | 5000 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2016 |
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).
AIM 1. To identify risk factors for reduced quality of life 2 yrs post-ACLR, from information available at the time of surgery; including the characteristics of the patients (age, gender, BMI, activity level, clinical knee alignment) and their injuries ("pop" heard at the time of injury, concurrent meniscus, articular cartilage, and collateral ligament injuries), and treatment decisions made during the initial surgery (e.g., meniscus and articular cartilage treatments).
AIM 2. To identify risk factors for symptoms and signs of osteoarthritis 2-yrs 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| Ages Eligible for Study: | 10 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Hospital for Special Surgery | |
| New York, New York, United States, 10021 | |
| United States, Ohio | |
| Cleveland Clinic | |
| 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 | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Kurt P. Spindler, M.D. | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Kurt P. Spindler, MD ) |
| Study ID Numbers: | 990426, R01-AR53684-01A1 |
| Study First Received: | April 19, 2007 |
| Last Updated: | June 16, 2008 |
| ClinicalTrials.gov Identifier: | NCT00463099 History of Changes |
| Health Authority: | United States: Institutional Review Board; United States: Federal Government |
|
Anterior Cruciate Ligament/injuries Anterior Cruciate Ligament/surgery Knee injuries/surgery Outcomes research Prospective Studies |