Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up

February 19, 2024 updated by: Kurt P. Spindler, Vanderbilt University Medical Center
In this study the investigators 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.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The purpose of this study is to identify risk factors for signs and symptoms of osteoarthritis two and ten year post ACL reconstruction from information available at the time of surgery. Hypothesis: Smoking status, older age, higher BMI, increased severity of cartilage injuries, increased meniscal resection, revision surgery, and incidence of additional arthroscopic procedures will result in more symptoms and signs of osteoarthritis at 10-year follow-up.

Primary outcome measures will be the joint space width measured on weight-bearing radiographs, as well as the pain subscale of the Knee Injury and Osteoarthritis Score (KOOS).

Secondary outcome measures will include the knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS).

Study Type

Observational

Enrollment (Estimated)

300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants enrolled in the Multicenter Orthopaedic Outcomes Network cohort by one of study site surgeons and meeting eligibility criteria

Description

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, St. Louis), or Dr. Matthew Matava (Washington University, St. Louis).
  • Participated in the 2 yr onsite visit

Exclusion Criteria:

  • Unable to be consented
  • Unable to participate for health reasons
  • History of intra-articular knee infection
  • History of total knee arthroplasty on either knee

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Joint space width measured on weight-bearing radiographs
Time Frame: 10 years after ACL reconstruction surgery
10 years after ACL reconstruction surgery
Pain subscale of the Knee Injury and Osteoarthritis Score (KOOS).
Time Frame: 10 years after ACL reconstruction surgery
10 years after ACL reconstruction surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS)
Time Frame: 10 years after ACL reconstruction surgery
10 years after ACL reconstruction surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Washington University School of Medicine
The Cleveland Clinic
Ohio State University

Investigators

  • Principal Investigator: Kurt P Spindler, MD, Vanderbilt University / The Cleveland Clinic Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 17, 2016

First Posted (Estimated)

March 23, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 160049

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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