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Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up (MOON-Onsite)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Kurt P. Spindler, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00478894
First received: May 24, 2007
Last updated: December 7, 2015
Last verified: December 2015
  Purpose
In this study we will examine patients who have undergone unilateral ACL reconstruction surgery to determine which structural and functional characteristics of the knee two and ten years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.

Condition
Rupture of Anterior Cruciate Ligament
Osteoarthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Side to side knee joint space difference as seen on x-ray [ Time Frame: 2-10 years post surgery ] [ Designated as safety issue: No ]

Enrollment: 432
Study Start Date: August 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of this study is identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery; including patient characteristics (age, gender, body mass index (BMI), activity level, clinical knee alignment), 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.)

Primary outcome measures will be the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain and stiffness subscales and joint space width measured on weight-bearing radiographs.

Secondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) and Kellgren-Lawrence grading from weight-bearing radiographs.

  Eligibility

Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of three surgeons and meeting eligibility criteria
Criteria

Inclusion Criteria:

  • Had primary unilateral ACL reconstruction performed by Dr. Kurt Spindler (Vanderbilt University), Dr. Christopher Kaeding (The Ohio State University), Dr. Rick Parker (Cleveland Clinic), Dr. Jack Andrish (Cleveland Clinic), Dr. Rick Wright (Washington University in St. Louis), or Dr. Matthew Matava (Washington University in St. Louis)
  • 12-45 years of age at the time of follow-up

Exclusion Criteria:

  • less than 12 years or greater than 45 years
  • Contralateral ACL reconstruction
  • Contralateral ACL deficiency
  • Contralateral knee surgery
  • non-active or unable to participate for health reasons
  • Revision ACL reconstruction
  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: NCT00478894

Locations
United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63110
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Kurt P Spindler, M.D. Cleveland Clinic / Vanderbilt University
  More Information

Publications:
Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00478894     History of Changes
Other Study ID Numbers: 070264  5R01AR053684 
Study First Received: May 24, 2007
Last Updated: December 7, 2015
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
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Rupture
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on December 02, 2016