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NCT04088227 · ClinicalTrials.gov registry record · Phase 2
Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears
A Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture, sponsored by Andrews Research & Education Foundation.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04088227: Completed Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture, sponsored by Andrews Research & Education Foundation.
NCT04088227 is a Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture that has completed, run by Andrews Research & Education Foundation. The registered enrollment target is 24 participants, below the 228-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04088227, a Phase 2 study of Anterior Cruciate Ligament Tear and Anterior Cruciate Ligament Rupture, has completed, sponsored by Andrews Research & Education Foundation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis following anterior cruciate ligament injuries. Current literature has begun to indicate that biochemical changes in the knee joint cartilage, such as chondrocyte death, following injury can contribute to the development of post-traumatic osteoarthritis. The main objective of this study is to determine if an early intervention of joint aspiration and platelet rich plasma injection will positively affect the biomarkers representative of chondral degeneration in patients with anterior cruciate ligament injuries. We hypothesize that the intervention will reduce the volume of inflammatory and chondrodegenerative biomarkers following anterior cruciate ligament injury.
Primary Outcome
The presence of the Synovial Interleukin (IL) -1 Receptor Antagonist biomarker in the synovial fluid will be assessed.
Conditions Studied
Interventions
- OTHER Control Group
- DRUG Experimental Group
Study Locations (1)
Florida
- Andrews Institute for Orthopaedics & Sports Medicine - Gulf Breeze
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-09-12 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 2 |
What the finished NCT04088227 record still lists
NCT04088227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 228-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Anterior Cruciate Ligament Tear appearing as the primary indexed condition, and to 2 interventions - of which Control Group is the first listed.
NCT04088227 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04088227 about?
NCT04088227 is a clinical study titled "Effects of Platelet Rich Plasma Injections on Biomarkers After Anterior Cruciate Ligament Tears". A potential long-term consequence of anterior cruciate ligament injuries is the development of post-traumatic osteoarthritis in the years following injury. There are no curative treatments for osteoarthritis, increasing the importance of minimizing the occurrence of post-traumatic osteoarthritis fol...
What is the current status of trial NCT04088227?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2019-09-12. Estimated completion is 2023-04-21.
What conditions does trial NCT04088227 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Rupture.
What interventions are being tested in trial NCT04088227?
The interventions under investigation include: Control Group (OTHER), Experimental Group (DRUG).
Who is sponsoring clinical trial NCT04088227?
This trial is sponsored by Andrews Research & Education Foundation, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04088227 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04088227's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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