Improved Otologic Implants On Demand Intraoperatively with 3D CAD/CAM Autografts

 描述(申请人提供)：在手术中使用的数百种人工中耳植入物中，约有10%被人体排斥。其中包括全听骨置换假体(TORPS)和部分听骨置换假体(PORPS)。在手术过程中，锤骨、砧骨和砧骨都不存在或已被移除时，通常使用扭转器。当链条上的最后一块骨头--腓骨存在，但锤骨和砧骨缺失或已被切除时，通常使用门静脉。Torps和Porps价格昂贵，需要在手术室中进行大量库存，并存在排斥反应的风险，例如移植手术。可以使用自体骨和软骨，或自体移植，这是从患者身上获取的材料，用于同一患者，但它们需要昂贵的手术室时间才能雕刻成正确的形状和大小。需要成本更低、挤出/感染率更低、可获得性更高的假体。Nitinetics LLC公司开发了减影3D CAD/CAM(计算机辅助设计和制造)，允许在手术室生产精确的自体骨和软骨移植。这项技术可以减少手术室时间，减少对各种中耳假体设备昂贵库存的需求，从而节省资金。由于自体材料不太可能挤出或导致感染，这也可以降低成本。此外，原材料(患者自己的骨骼)的成本为零。我们打算评估这种CAD/CAM技术是否比假体设备更具成本效益并减少并发症。这个第一阶段的项目将包括一项临床试验，在该试验中，需要中耳再造手术的患者将接受两种中耳植入物中的一种植入。两种中耳植入物将如下：对照组为Sheehy部分听骨置换假体，实验组为计算机生成的设计相同的自体部分听骨置换假体，由患者自己的骨骼制成。将前瞻性地测量以下参数：制造所需的手术室时间、成本、手术前后的听力结果、感染率和排斥率。每个植入物的大小将根据患者的解剖因素不同而有所不同。患者将以双盲方式随机进行。计算机化的自体听骨置换技术有望提供一种改进的产品，该产品将减少感染、排斥和/或听力损失等并发症，并为患者带来成本效益。

 DESCRIPTION (provided by applicant): Of all the hundreds of types of synthetic middle ear implants that are used in surgery, approximately 10% of these are rejected by the body. These include total ossicular replacement prostheses (TORPs) and partial ossicular replacement prostheses (PORPs). TORPs are used in general when during surgery, it is noted that the malleus, incus and stapes are all absent or have been removed. PORPs are generally used when the stapes, the last bone in the chain, is present but the malleus and incus are absent or have been removed. TORPs and PORPs are expensive, require large inventories in the operating room, and carry the risk of rejection such as with transplant surgery. Autologous bone and cartilage, or autografts, which are materials harvested from the patient for use in the same patient, can be used, but they require expensive operating room time for carving to the right shape and size. There is a need for prosthetics with decreased cost, decreased extrusion/infection rates, and increased availability. Nitinetics LLC has developed subtractive 3D CAD/CAM (computer assisted design and manufacture) which allows the production of accurate bone and cartilage autografts in the operating room. This technology can save money by reducing operating room time and reducing the need for expensive inventories of diverse middle ear prosthetic devices. Since autologous materials are less likely to extrude or cause infection, this could also reduce costs. Additionally, the cost of raw material (the patient's own bone) is zero. We intend to evaluate whether this CAD/CAM technology is more cost-effective and results in reduced complications compared to prosthetic devices. This Phase I project will consist of a clinical trial in which consenting patients requiring middle ear reconstruction surger will be implanted with one of two middle ear implants. The two middle ear implants will be as follows: Sheehy Partial Ossicular Replacement Prosthesis in the control group, and computer-generated autograft partial ossicular replacement prosthesis with the identical design, made out of the patient's own bone in the experimental group. The following parameters will be prospectively measured: Operating room time required for fabrication, cost, pre- and post-operative hearing results, infection rates, and rejection rates. Different sizes of each implant wil be available depending on individual patient anatomical factors. Patients will be randomized in a double-blind manner. The computerized autograft ossicular replacement technique is anticipated to provide an improved product that will result in decreased complications such as infection, rejection, and/or hearing loss as well as a cost-benefit to patients.