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Recruiting NCT07536399

Biologic Augmentation of TMJ Arthroscopy Using BMAC

Phase III Interventional TMJ - Oral &Maxillofacial Surgery Oral and Maxillofacial Conditions TMJ Pain TMJ Arthralgia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone Marrow Aspirate Concentrate, Corticosteroid (CS).
Who it may be relevant to
Registry conditions: TMJ - Oral &Maxillofacial Surgery, Oral and Maxillofacial Conditions, TMJ Pain, TMJ Arthralgia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Biological Bone Marrow Aspirate Concentrate
    Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
  • Drug Corticosteroid (CS)
    Single dose injection of cortiosteroid into the TMJ area during arthroscopy.

Primary outcome measures

  • Change from Baseline in Kellenberger score at 6 Months. [Time frame: Baseline; 6 months]
Secondary outcome measures (3)
  • Change in Maximum interincisal opening (MIO) [Time frame: Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op]
  • Change in Pain Scores [Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op]
  • Change in Jaw Functional Limitation Scale (JFLS) Score [Time frame: Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op]

Eligibility criteria

Inclusion criteria

  • Participant is at least 18 years of age and not older than 75 years of age
  • Participant is willing and able to provide written informed consent to participant in this study
  • 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.)
  • Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS)

Exclusion criteria

  • Participant has not competed at least 30 days of conservative therapy
  • Participant was diagnosed with central or neuropathic pain disorder
  • Participant has a primary diagnosis of myofascial pain
  • Participant has fibromyalgia
  • Participant is pregnant or breastfeeding
  • Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Weill Cornell Medical College - NewYork-Presbyterian Hospital — New York

Identifiers

NCT: NCT07536399 · 25-08029208

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗