Full Text View
Tabular View
No Study Results Posted
Related Studies
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ALCR): Onsite Follow-up (MOON Onsite)
This study is enrolling participants by invitation only.
First Received: May 24, 2007   Last Updated: February 26, 2008   History of Changes
Sponsors and Collaborators: Vanderbilt University
National Institutes of Health (NIH)
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00478894
  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 years post reconstruction surgery, aspects of the original injury and repair, and patient characteristics are risk factors for osteoarthritis after ACL reconstruction surgery.


Condition
Anterior Cruciate Ligament
Osteoarthritis

MedlinePlus related topics: Osteoarthritis Surgery
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ALCR): Onsite Follow-up

Further study details as provided by Vanderbilt University:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 300
Study Start Date: August 2007
Estimated Study Completion Date: August 2010
Detailed Description:

The purpose of this study is identify risk factors for signs and symptoms of osteoarthritis two 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 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
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), or Dr. Rick Parker (Cleveland Clinic)
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478894

Locations
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
Investigators
Principal Investigator: Kurt P Spindler, M.D. Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Kurt Spindler, MD )
Study ID Numbers: 070264, RO1-AR53684-01A1
Study First Received: May 24, 2007
Last Updated: February 26, 2008
ClinicalTrials.gov Identifier: NCT00478894     History of Changes
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

Study placed in the following topic categories:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Knee Injuries
Rheumatic Diseases

Additional relevant MeSH terms:
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 07, 2009