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（由申请人提供）：数百万美国人患有颞下颌关节（TMJ）疾病，影响他们的饮食，说话和生活能力。对于那些关节对基本治疗没有反应并继续存在长期问题的患者，医生可能会建议进行外科手术以纠正关节中的潜在问题。最后一种可用的治疗形式是用植入的假体对整个关节进行手术置换。通常，接受这一最终建议的患者已经忍受了多年的痛苦和许多形式的部分治疗问题;经常光顾来自不同领域的许多不同医生，如神经外科医生，风湿病学家和牙科医生。美国国立卫生研究院目前的指导建议，在采取不可逆的手术治疗之前，所有形式的治疗都应用尽;全关节置换术是最后的治疗手段。有很多人需要这种最终治疗，但医生不愿意建议进行手术。Vista工程公司和位于伯明翰的亚拉巴马大学（UAB）一直在开发下一代金刚石表面TMJ假体植入物，试图彻底改变这一市场。该器械的侵入性较小，减少了外科手术，生物相容性更好。该装置的本质是创新的，因为它不是一个完全的关节置换装置，而是一个表面置换装置，其中保留了大部分现有关节，包括所有关节稳定肌肉。这项研究具有创新性，因为TMJ的动物模型尚未得到证实。此外，用于植入物的金刚石表面的长期可行性没有得到很好的研究。这项拟议的研究将在为期12个月的动物试验结束时评估UAB-Vista金刚石表面TMJ的性能，该试验涉及7只小型猪的28个金刚石表面植入物和第八只对照器械。外科医生将在拔牙前检查TMJ的组织和健康状况。对取出器械的研究将侧重于骨与植入物的整合，并寻找巨细胞异物（GCFB）反应的证据。将通过实验室研究确定金刚石表面的完整性、关节性能的指示以及器械与骨的固定。