?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.
Public Health Relevance Statement: Public Health Relevance: There is an unmet medical need for improved ear surgery techniques. This is because many artificial middle ear implants are rejected by the body. Making implants out of the patient's own bone or cartilage using a computerized device in the OR will improve public health by decreasing ear surgery complications such as infection and rejection.
Project Terms: Anatomy; Auricular prosthesis; Autologous; Autologous Transplantation; base; bone; Cartilage; Clinical Trials; computer generated; Computer software; Computer-Aided Design; Computer-Assisted Manufacturing; computerized; Consent; Control Groups; cost; cost effective; Costs and Benefits; Data; design; Devices; Double-Blind Method; Environment; Equipment and supply inventories; Harvest; Hearing; hearing impairment; Implant; improved; Incus structure; individual patient; Infection; Institutional Review Boards; Malleus; Measures; Medical; middle ear; 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; public health relevance; Randomized; reconstruction; Risk; Safety; Services; Shapes; standard of care; Stapes; Techniques; Technology; Time; Transplantation; United States
