We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00478894
Recruitment Status : Active, not recruiting
First Posted : May 25, 2007
Last Update Posted : January 10, 2022
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

Brief Summary:
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 or disease
Rupture of Anterior Cruciate Ligament Osteoarthritis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 432 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up
Study Start Date : August 2007
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Side to side knee joint space difference as seen on x-ray [ Time Frame: 2-10 years post surgery ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

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): NCT00478894

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: Kurt P Spindler, M.D. Cleveland Clinic / Vanderbilt University
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kurt P. Spindler, Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00478894    
Other Study ID Numbers: 070264
5R01AR053684 ( U.S. NIH Grant/Contract )
First Posted: May 25, 2007    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
Keywords provided by Kurt P. Spindler, Vanderbilt University:
Anterior cruciate ligament / injuries
Anterior cruciate ligament / surgery
knee injuries / surgery
outcomes research
prospective studies
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries