Health TrialsbyHealthPanel

Intraoperative Bone Marrow Aspirate Concentrate Injections: Evaluating Outcomes in a Randomized Controlled Trial

ConditionsLabral TearFemoroacetabular Impingement
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bone marrow aspirate concentrate

    Biological/Vaccine

    145cc of BMAC/PRP/PPP injection.

  • Hip arthroscopy

    Procedure/Surgery

    Both groups will undergo a hip arthroscopy to treat their condition. However, the control group will not receive a BMAC injection during the surgery.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: BMAC ArmExperimental treatment 2 interventions
Group B: No BMAC (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

iHOT-12

Time frame
2 years

Secondary outcomes

1

modified Harris Hip Score

Time frame
2 years
2

Non-arthritic hip score

Time frame
2 years
3

Hip outcome score-sports specific subscale

Time frame
2 years
4

Visual analog scale

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

American Hip Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: