Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-01-06 @ 9:50 AM
Study NCT ID:
NCT00478894
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-14
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Orthopaedic Outcomes Network (MOON) ACL Reconstruction (ACLR): Onsite Follow-up
Sponsor:
Vanderbilt University
Organization:
Study Overview
Official Title:
Multicenter Orthopaedic Outcomes Network (MOON) Anterior Cruciate Ligament (ACL) Reconstruction (ACLR): Onsite Follow-up
Status:
ACTIVE_NOT_RECRUITING
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:
MOON-Onsite
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5R01AR053684 | NIH | None | https://reporter.nih.gov/quic… | View |