Clinical trial NCT02717559: Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Official title: Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Keywords: Anterior cruciate ligament / injuries
Anterior cruciate ligament / surgery
knee injuries / surgery
outcomes research
prospective studies
osteoarthritis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Ohio State University
name: Washington University School of Medicine
First posted: 2016-03-23
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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).

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, 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

Primary outcomes:
measure: Joint space width measured on weight-bearing radiographs
timeFrame: 10 years after ACL reconstruction surgery
measure: Pain subscale of the Knee Injury and Osteoarthritis Score (KOOS).
timeFrame: 10 years after ACL reconstruction surgery
Secondary outcomes:
measure: Knee related quality of life subscale of the Knee Injury and Osteoarthritis Score (KOOS)
timeFrame: 10 years after ACL reconstruction surgery
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University / The Cleveland Clinic Foundation
name: Kurt P Spindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: MOON Group; Everhart JS, Jones MH, Yalcin S, Reinke EK, Huston LJ, Andrish JT, Cox CL, Flanigan DC, Kaeding CC, Magnussen RA, Obuchowski N, Parker RD, Pedroza AD, Sanders RA, Winalski CS, Spindler KP. The Clinical Radiographic Incidence of Posttraumatic Osteoarthritis 10 Years After Anterior Cruciate Ligament Reconstruction: Data From the MOON Nested Cohort. Am J Sports Med. 2021 Apr;49(5):1251-1261. doi: 10.1177/0363546521995182.