Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial

Clinical Trial Details

We hope 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. We are recruiting patients that have a diagnosis of pain (arthralgia) of the temporomandibular joint (TMJ) that has failed to respond to conservative treatment.
   
Participants will be randomized to receive either BMAC or CS injection during TMJ arthroscopy. There is an equal chance of you being in either intervention group.

In addition to the procedure there will be screening assessments and several follow up visits. Participants will have regularly scheduled follow-up appointments at 2-4 weeks, 3 months and 6 months post-surgery, regardless of the intervention they are assigned to. At baseline and 6 months, there will also be a magnetic resonance imaging (MRI) of the jaw.

Key Eligibility: 

 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 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.)
   
Exclusion Criteria:
   1. Participant has not competed at least 30 days of conservative therapy
   2. Participant was diagnosed with central or neuropathic pain disorder
   3. Participant has a primary diagnosis of myofascial pain
   4. Participant has fibromyalgia
   5. Participant is pregnant or breastfeeding
   6. Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening
   7. Participant who have the contraindications to MRI

Detailed eligibility will be discussed when reaching out to the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Jordan Augsburger
646-962-2270
joa7035@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2508029208

Status

Not Yet Recruiting

Age Group

Adult

Sponsor