Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from Baseline in Kellenberger score at 6 Months.
概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Corticosteroid Arm
Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure
干预措施: Corticosteroid (CS) (Drug)
BMAC Arm
Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure
干预措施: Bone Marrow Aspirate Concentrate (Biological)
结局指标
主要结局
Change from Baseline in Kellenberger score at 6 Months.
时间窗: Baseline; 6 months
Participant MRIs will be given a Kellenberger score of 0-13. A higher Kellenberger scores indicate a higher degree of inflammation and damage.
次要结局
- Change in Maximum interincisal opening (MIO)(Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op)
- Change in Pain Scores(Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op)
- Change in Jaw Functional Limitation Scale (JFLS) Score(Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op)