Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial
Weill Medical College of Cornell University
Summary
The goal of this clinical trial is to learn about the efficacy of using Bone Marrow Aspirate Concentrate (BMAC) during temporomandibular joint (TMJ) arthroscopy compared to standard arthroscopic procedures with corticosteroid (CS) injections in patients with pain (arthralgia) of the temporomandibular joint (TMJ) that has failed to respond to conservative treatment. The main question it aims to answer: Does BMAC injection reduce the amount of inflammation and structural damage in the TMJ? Researchers will compare BMAC injection to corticosteroid injections see if BMAC injection helps . Participants will : * Be randomized to receive either BMAC or CS injection during TMJ arthroscopy * Visit the clinic for 3 follow up visits over 6 months and answer questionnaires * have 2 MRIs of their jaw
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participant is at least 18 years of age and not older than 75 years of age 2. Participant is willing and able to provide written informed consent to participant in this study 3. Participant has symptoms of TMJ arthralgia (pain) with significant temporomandibular joint pain and dysfunction despite at least 30 days of conservative therapy (NSAIDS, muscle relaxants, bite splints, PT, warm compresses, soft diet, etc.) 4. Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS) Exclusion Criteria: 1. Participant has not competed at least 30 days of conserv…
Interventions
- BiologicalBone Marrow Aspirate Concentrate
Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
- DrugCorticosteroid (CS)
Single dose injection of cortiosteroid into the TMJ area during arthroscopy.
Location
- Weill Cornell Medical College - NewYork-Presbyterian HospitalNew York, New York