Multicenter Orthopaedics Outcomes Network for ACL Reconstructions

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00463099
First received: April 19, 2007
Last updated: June 11, 2013
Last verified: June 2013
  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
Rupture of Anterior Cruciate Ligament

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognosis and Predictors of ACL Reconstruction - A Multicenter Cohort Study

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • patient-reported outcome measures [ Time Frame: 2, 6, and 10 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Signs and symptoms of osteoarthritis [ Time Frame: 2, 6, and 10 years ] [ Designated as safety issue: No ]
    Signs of OA (as measured by joint space narrowing on a standing radiograph). Symptoms of OA (as measured by WOMAC and KOOS pain subscales).


Other Outcome Measures:
  • ACL graft failure [ Time Frame: 2, 6, and 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: January 2007
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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 2-10 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 (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.

  Eligibility

Ages Eligible for Study:   10 Years to 33 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • All ACL-deficient candidates scheduled for a unilateral ACL reconstruction at one of the participating MOON sites.
  • Between 10 and 33 years of age
  • Injured while playing a sport
  • Normal contralateral leg (no previous surgeries)

Exclusion Criteria:

  • Persons undergoing a simultaneous bilateral ACL reconstruction
  • Patients less than 10 years old and older than 33 years old
  • patients not injured while playing a sport (e.g., MVA, ADL)
  • Patients unwilling or unable to complete their repeat questionnaire 2,6, and 10 years after their initial visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463099

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
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Kurt P. Spindler, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00463099     History of Changes
Other Study ID Numbers: 990426, R01AR053684
Study First Received: April 19, 2007
Last Updated: June 11, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Vanderbilt University:
Anterior Cruciate Ligament/injuries
Anterior Cruciate Ligament/surgery
Knee injuries/surgery
Outcomes research
Prospective Studies

Additional relevant MeSH terms:
Rupture
Wounds and Injuries

ClinicalTrials.gov processed this record on August 28, 2014