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NCT03497780 · ClinicalTrials.gov registry record
Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:
A clinical trial, sponsored by University of Michigan.
- Terminated
- Registry status
- 13
- Enrollment target
NCT03497780: Clinical Trial study, sponsored by University of Michigan.
NCT03497780 is a clinical trial that was terminated before completion, run by University of Michigan. The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03497780 was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- 13 participants
- Enrollment target
Study Summary
The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of post-traumatic osteoarthritis (PTOA) after ACL injury and reconstruction. The study aims to enroll N=38 total patients with primary, isolated rupture to their anterior cruciate ligament (ACL), who have agreed to participate in the study and who will undergo primary surgical reconstruction by an orthopaedic physician at our two sites. Patients will undergo baseline magnetic resonance imaging (MRI), baseline clinical evaluation, and undergo a baseline blood draw. Subsequent imaging and clinical evaluations will be longitudinally performed at several postoperative timepoints up to 12 months postoperatively.
Primary Outcome
One-year change in articular cartilage surface roughness based on quantitative morphological assessment with 3D MRI.
Interventions
- PROCEDURE Anterior cruciate ligament reconstruction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2021-03-25 |
Why NCT03497780 stopped before completion
NCT03497780 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 13 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Anterior cruciate ligament reconstruction is the first listed.
NCT03497780 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03497780 about?
NCT03497780 is a clinical study titled "Longitudinal Assessment of Cartilage Injury and Remodeling After Anterior Cruciate Ligament Rupture and Reconstruction:". The proposed study will establish novel relationships between intra-articular mesenchymal stem cell (MSC) recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to p...
What is the current status of trial NCT03497780?
This trial is currently terminated. The enrollment target is 13 participants. The study started on 2018-11-08. Estimated completion is 2021-03-25.
What interventions are being tested in trial NCT03497780?
The interventions under investigation include: Anterior cruciate ligament reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT03497780?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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