Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT02717559
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-14
First Post:
2016-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Sponsor:
Vanderbilt University Medical Center
Organization:
Study Overview
Official Title:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): 10 Year Onsite Follow-up
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: