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NCT02717559 Clinical Trial

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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02717559
Other study ID # 160049
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date March 2016
Est. completion date December 2025

Study information
Verified date February 2024
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 300
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Vanderbilt University Medical Center Ohio State University, The Cleveland Clinic, Washington University School of Medicine

Outcome
Type Measure Description Time frame Safety issue
Primary Joint space width measured on weight-bearing radiographs 10 years after ACL reconstruction surgery
Primary Pain subscale of the Knee Injury and Osteoarthritis Score (KOOS). 10 years after ACL reconstruction surgery
Secondary Knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS) 10 years after ACL reconstruction surgery
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