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

使用 3D CAD/CAM 自体移植改进术中按需耳科植入物

• 批准号: 9133216
• 负责人: Alisa Knox
• 金额: $ 21.5万
• 依托单位: NITINETICS, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9133216
• 关键词: Anatomy; Auricular prosthesis; Autologous; Autologous Transplantation; Cartilage; Clinical Trials; Computer software; Computer-Aided Design; Computer-Assisted Manufacturing; Consent; Control Groups; Costs and Benefits; Data; Devices; Double-Blind Method; Environment; Equipment and supply inventories; Harvest; Hearing; Implant; Incus; Infection; Institutional Review Boards; Malleus; Measures; Medical; Middle Ear Implant; Operating Rooms; Operative Surgical Procedures; Ossicular Prosthesis Implantation; Ossicular Replacement Prosthesis; Otologic Surgical Procedures; Outcome; Outpatients; Patients; Phase; Pilot Projects; Postoperative Period; Production; Prosthesis; Public Domains; Public Health; Randomized; Risk; Safety; Services; Shapes; Stapes; Techniques; Technology; Time; Transplantation; United States; base; bone; computer generated; computerized; cost; cost effective; design; hearing impairment; improved; individual patient; middle ear; public health relevance; reconstruction; standard of care

 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.

 描述（由申请人提供）：在手术中使用的数百种合成中耳植入物中，约有10%被身体排斥。这些包括全听骨关节置换假体（TORP）和部分听骨关节置换假体（PORP）。TORP通常在手术过程中使用，注意到锤骨、鞋钉和镫骨均缺失或已被切除。PORP通常用于存在镫骨（链条中的最后一块骨）但锤骨和砧骨缺失或已被切除的情况。TORP和PORP是昂贵的，需要在手术室大量库存，并进行排斥反应的风险，如移植手术。自体骨和软骨，或自体移植物，这是从病人身上采集的材料，用于同一病人，可以使用，但他们需要昂贵的手术室时间雕刻到正确的形状和大小。 需要具有降低的成本、降低的挤出/感染率和增加的可用性的假体。Nittlewood LLC开发了减法3D CAD/CAM（计算机辅助设计和制造），可以在手术室中生产精确的骨和软骨自体移植物。这项技术可以通过减少手术室时间和减少对各种中耳假体设备的昂贵库存的需求来节省资金。由于自体材料不太可能挤出或引起感染，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技术是否比假体器械更具成本效益，并减少并发症。 该I期项目将包括一项临床试验，在该试验中，需要中耳重建外科医生的同意患者将植入两种中耳植入物中的一种。两种中耳植入物如下：对照组为Sheehy部分听骨置换假体，实验组为计算机生成的自体移植部分听骨置换假体，设计相同，由患者自身骨制成。将前瞻性测量以下参数：制造所需的手术室时间、成本、术前和术后听力结果、感染率和排斥率。每个植入物的不同尺寸将取决于个体患者的解剖因素。患者将以双盲方式随机分配。预计计算机化自体移植听骨置换技术将提供一种改进的产品，从而减少并发症，如感染、排斥反应和/或听力损失，并为患者带来成本效益。