Retrieval and Bio-material-compatibility Analyses of Prototype Temporomandibular Joint Implants Following 12-month Study in Swine

经过 12 个月的猪研究后，原型颞下颌关节植入物的回收和生物材料相容性分析

• 批准号: 8905340
• 负责人: Raymond G. Thompson
• 金额: $ 22.19万
• 依托单位: VISTA ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-15 至 2016-08-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8905340
• 关键词: Affect; Alabama; American; Animal Model; Animals; Behavior; Biocompatible; Dental; Devices; Diamond; Disease; Eating; Engineering; Family suidae; Foreign-Body Reaction; Giant Cells; Grant; Health; Implant; Investigation; Joint Prosthesis; Joints; Laboratories; Lead; Legal patent; Life; Marketing; Muscle; Nanostructures; Nature; Neurosurgeon; Operative Surgical Procedures; Patients; Performance; Procedures; Process; Production; Prostheses and Implants; Prosthesis Design; Reaction; Recommendation; Replacement Arthroplasty; Research; Resort; Retrieval; Surface; Surgeon; Temporomandibular Joint; Temporomandibular Joint Disorders; Testing; Tissue Sample; Tissues; United States National Institutes of Health; Universities; biomaterial compatibility; bone; design; exhaust; human subject; implantation; in vivo; innovation; minimally invasive; nanostructured; next generation; prototype; public health relevance; rheumatologist; sample fixation; soft tissue; success

 DESCRIPTION (provided by applicant): Millions of Americans suffer from the debilitating disease of temporomandibular joint (TMJ) disorder, affecting their ability to eat, talk and live their lives. For the patients whose joints do not respond to basic treatments and continue to have long term problems, a doctor may recommend to perform surgical procedures to correct underlying problems in the joint. The last form of treatment available is the surgical replacement of the entire joint with an implanted prosthesis. Often the patient that receives this final recommendation has endured years of suffering and many forms of partial treatment of the problem; frequenting many different doctors from different fields, such as neurosurgeons, rheumatologists, and dental surgeons. Current guidance from the NIH suggests that all forms of treatment be exhausted before resorting to a non-reversible surgical treatment; the total joint replacement being the treatment of last resort. There are a large number of people for whom this final treatment is necessary but doctors are reluctant to recommend that the surgery be performed. Vista Engineering and the University of Alabama at Birmingham (UAB) have been developing a next generation diamond surfaced TMJ prosthesis implant in an attempt to revolutionize this market. This device is less invasive, with a reduced surgical procedure, and greater biocompatibility. The very nature of the device is innovative in that it is not a total joit replacement device, but a resurfacing device where the majority of the existing joint is retained including all the joint stabilizing muscles. The proposed research is innovative because an animal model for the TMJ has not been proven. Furthermore, the long term viability of diamond surfaces for implants is not well studied. The proposed research will evaluate the performance of the UAB-Vista diamond surfaced TMJ at the conclusion of a 12-month animal trial involving 28 diamond surfaced implants in 7 miniature pigs plus a control device in an eighth. The surgeon will examine the tissue and health of the TMJ prior to extraction. Research on the explant devices will focus on the integration of the bone to the implant and a search for evidence of giant cell foreign body (GCFB) reactions. The integrity of the diamond surfaces, indications of articulation behavior and the fixation of the device to the bone will be determined through laboratory investigations.

 描述（由适用提供）：数以百万计的美国人患有颞下颌关节（TMJ）疾病的使人衰弱的疾病，影响了他们的饮食能力，说话和过生生活。对于关节不反应基本治疗并继续存在长期问题的患者，医生可能建议执行手术程序以纠正关节中的潜在问题。可用的最后一种治疗形式是通过NIH的当前指导对整个关节进行手术替换表明，在诉诸于非可逆手术治疗之前，所有形式的治疗方法都耗尽。总置换量是对最后一个度假胜地的处理。有很多人需要这种最终治疗的人，但医生不愿意建议进行手术。 Vista Engineering和Alabama的伯明翰大学（UAB）一直在开发下一代钻石浮出水面的TMJ假体植入物，以试图彻底改变该市场。该设备的侵入性较小，手术程序降低，生物相容性更大。该设备的本质是创新的，因为它不是总的插入装置，而是一种重新铺面装置，其中大部分现有关节都保留在内，包括所有关节稳定的肌肉。拟议的研究具有创新性，因为尚未证明TMJ的动物模型。此外，钻石表面的长期生存能力并不能很好地研究。拟议的研究将在一项为期12个月的动物试验结束时评估UAB-VISTA钻石表面TMJ的性能，其中涉及28个微型猪中的28个钻石浮出水面，以及第八分中的控制装置。外科医生将在提取前检查TMJ的组织和健康。对膨胀设备的研究将集中于骨骼与植入物的整合，并寻求巨型细胞异物（GCFB）反应的证据。钻石表面的完整性，表达行为的指示以及设备对骨骼的固定将通过实验室研究确定。