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

 描述(申请人提供)：数以百万计的美国人患有令人衰弱的颞下颌关节(TMJ)疾病，影响他们的饮食、说话和生活能力。对于关节对基本治疗没有反应并持续存在长期问题的患者，医生可能会建议进行外科手术，以纠正关节的潜在问题。最后一种可用的治疗方式是用植入的假体对整个关节进行外科置换。通常，接受这一最终建议的患者已经忍受了多年的痛苦和对问题的多种形式的局部治疗；经常去看来自不同领域的不同医生，如神经外科医生、风湿病医生和牙科外科医生。美国国立卫生研究院目前的指导意见建议，在诉诸不可逆转的手术治疗之前，应用尽所有形式的治疗；全关节置换是最后的治疗手段。有大量的人有必要进行最后的治疗，但医生不愿建议进行手术。Vista Engineering和阿拉巴马大学伯明翰分校(UAB)一直在开发下一代钻石表面TMJ假体，试图彻底改变这一市场。这种装置侵入性更小，手术过程更少，生物兼容性更好。该装置的本质是创新的，因为它不是完全关节置换装置，而是一种重新铺设装置，其中保留了现有关节的大部分，包括所有关节稳定肌肉。这项拟议的研究具有创新性，因为TMJ的动物模型尚未得到证实。此外，用于植入的钻石表面的长期生存能力还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钻石表面TMJ的性能，动物试验涉及7只小型猪的28枚钻石表面植入物和8头小型猪的控制装置。外科医生将在拔除前检查TMJ的组织和健康状况。植入物装置的研究将集中在骨与植入物的结合以及寻找巨细胞异物(GCFB)反应的证据。钻石表面的完整性、关节行为的迹象以及装置与骨骼的固定将通过实验室调查来确定。

 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.