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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 12 Years - 45 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00478894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Vanderbilt University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kurt P Spindler, M.D.
Principal Investigator Affiliation Cleveland Clinic / Vanderbilt University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rupture of Anterior Cruciate Ligament, Osteoarthritis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Washington University in St. Louis, Saint Louis, Missouri

Status

Address

Washington University in St. Louis

Saint Louis, Missouri, 63110

Cleveland Clinic, Cleveland, Ohio

Status

Address

Cleveland Clinic

Cleveland, Ohio, 44195

The Ohio State University, Columbus, Ohio

Status

Address

The Ohio State University

Columbus, Ohio, 43221

Vanderbilt University, Nashville, Tennessee

Status

Address

Vanderbilt University

Nashville, Tennessee, 37232