Intraoperative Bone Marrow Aspirate Concentrate Injections: Evaluating Outcomes in a Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorAmerican Hip Institute
About this trial
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.
Eligibility criteria
Qualifiers
Patients undergoing primary hip arthroscopy to treat femoroacetabular impingement
Subjects will require a clinical diagnosis of intra-articular pathology consisting of anterior hip and/or groin pain with restricted hip motion and positive impingement testing.
Study inclusion also requires the radiographic hallmarks of Cam type femoroacetabular impingement with an alpha angle greater than 60 degrees on Dunn lateral views and advanced imaging with magnetic resonance imaging (MRI) or magnetic resonance arthrography (MRA) confirming chondrolabral pathology.
Disqualifiers
Patients who have had prior hip arthroscopy or hip surgery, Tonnis grade II or higher radiographic osteoarthritis, congenital hip deformities including Legg-Calve-Perthes or Slipped Capital Femoral Epiphysis, rheumatologic conditions, or workers compensation claims.
Patients undergoing additional arthroscopic procedures such as trochanteric bursectomy or gluteus medius repair will also be excluded.
Trial design
Treatments tested in this trial
- Bone marrow aspirate concentrate
- Hip arthroscopy
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov