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NCT06311513 · ClinicalTrials.gov registry record · Phase 4
Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction
A Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury, sponsored by Hospital for Special Surgery, New York.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT06311513 is a Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury that is actively recruiting participants, run by Hospital for Special Surgery, New York. The registered enrollment target is 40 participants, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (88% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06311513, a Phase 4 study of Anterior Cruciate Ligament Injuries and ACL Injury, is actively recruiting participants, sponsored by Hospital for Special Surgery, New York.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.
Conditions Studied
Interventions
- BIOLOGICAL Concentrated Bone Marrow Aspirate Injection
- PROCEDURE Sham Incision
- PROCEDURE Revision Anterior Cruciate Ligament Reconstruction
Study Locations (2)
Georgia
- Emory Orthopaedics & Spine Center - Atlanta
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-01-22 |
| Est. Completion | 2028-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06311513
The ClinicalTrials.gov registry entry for NCT06311513 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 321-participant average among 24 other Anterior Cruciate Ligament Injuries trials with a reported enrollment target (88% lower). The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Anterior Cruciate Ligament Injuries appearing as the primary indexed condition, and to 3 interventions - of which Concentrated Bone Marrow Aspirate Injection is the first listed.
NCT06311513 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT06311513 about?
NCT06311513 is a clinical study titled "Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction". The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer...
What is the current status of trial NCT06311513?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2024-01-22. Estimated completion is 2028-12.
What conditions does trial NCT06311513 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Injuries, ACL Injury, Bone Marrow Aspirate Concentrate, Post-Traumatic Osteoarthritis of Knee.
What interventions are being tested in trial NCT06311513?
The interventions under investigation include: Concentrated Bone Marrow Aspirate Injection (BIOLOGICAL), Sham Incision (PROCEDURE), Revision Anterior Cruciate Ligament Reconstruction (PROCEDURE).
Who is sponsoring clinical trial NCT06311513?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06311513 being conducted?
This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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