Intraoperative Bone Marrow Aspirate Concentrate Injections: Evaluating Outcomes in a Randomized Controlled Trial
NCT06750757 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-12-27
Summary
The purpose of this study is to see if bone marrow aspirate concentrate (BMAC) used with your hip arthroscopy surgery is a better treatment than just having surgery alone for treatment of labral tears in your hip.
BMAC is an injection, where your doctor will insert a needle into your hip and harvest the bone marrow that is located inside of your bones. This will be performed under anesthesia during your hip arthroscopy surgery and will be injected during the procedure. BMAC is an FDA approved procedure and has had many research articles produced from it.
Researchers will compare patients who received BMAC during their surgery to those who have not to determine if the injection with surgery is better than surgery alone.
Conditions
- Labral Tear
- Femoroacetabular Impingement
Interventions
- BIOLOGICAL
-
Bone marrow aspirate concentrate
145cc of BMAC/PRP/PPP injection.
- PROCEDURE
-
Hip arthroscopy
Both groups will undergo a hip arthroscopy to treat their condition. However, the control group will not receive a BMAC injection during the surgery.
Sponsors & Collaborators
-
American Hip Institute
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-02-28
- Primary Completion
- 2027-02-28
- Completion
- 2028-02-29
- FDA Drug
- Yes
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