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Biologic Augmentation of TMJ Arthroscopy Using BMAC

RecruitingPhase 3Ages 18 Years - 75 YearsAllWeill Medical College of Cornell University
NCT07536399 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 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 has the following contraindications to MRI: * Electrical implants such as cardiac pacemakers or perfusion pumps * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants * History of seizures * Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study. * Allergy to contrast die
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What it tests

  • Bone Marrow Aspirate Concentrate
  • Corticosteroid (CS)
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Where

1 site
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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