Surgical technique guides and design guidelines for 3-D Patient Specific Implants
Richard A. Hopper, Majeed Rana, Rainer Schmelzeisen
Fig 1 TruMatch Orthognathics -Correction Planning New techniques of three-dimensional imaging as well as rapid developments in computer-aided design (CAD) and computer-aided manufacturing (CAM) are changing the face of modern medicine. With the use of digital treatment planning and patient-specific templates, complex surgical procedures can especially be improved; this is true in terms of feasibility and accuracy, and in terms of operating time and clinical outcome. The increasing number of patient specific implant (PSI) options now available in craniomaxillofacial surgery can make treatment planning challenging for surgeons. Although the workflow for timely and accurate planning, production, and delivery of PSI has been well established, the specific steps to use them during surgery is less clearly defined.
The AOTK (CMF), specialized expert groups, and PSI industry partners have identified the need for support for surgeons in treatment planning to improve both clinical reliability and work flow efficiency. They identified an opportunity to clarify the specific surgical steps involved in using this new technology through the creation of detailed technique guides. This will allow surgeons to avoid having to develop a PSI treatment plan from scratch with each new patient. Although technique guides are available for non-PSI implants and devices, due to the custom nature of PSI technology, regulations regarding their design and use remain less established. This can place the onus on the surgeon alone to determine clinical indication, identify the treatment goals, design the device parameters, and incorporate them all into the surgical plan. Although industry staff and engineers are available as a technical resource in PSI planning, the AOTK has identified value in providing surgeons using PSI materials with a stepwise technique guide created by AO clinical experts.
As a first step in this initiative, a technique guide for the TruMatch Orthognathics Platform has been developed with the oversight of the AOTK (CMF), which explains all surgical steps in detail, including insights from experts into how to maximize both safety and accuracy (Figs 15). This project follows the AOTK principle that AO experts involved in the development of a device are also in best position to provide guiding advice on their indications and use.
The potential benefits and actual limits of an integrated 3-D virtual approach for the treatment of patients and requirements for craniomaxillofacial surgery are discussed comprehensively from our experience using 3-D virtual treatment planning clinically. The next steps for this initiative will be to design additional publications that will offer this same guidance during the online designing process of the TruMatch PSI products.
Fig 2 The steps in virtual planning. 
Fig 3a Le Fort I: Planning of the Osteotomy Guide 
Fig 3b Le Fort I: Use of the osteotomy guide and application of the corresponding plate resulting from virtual planning. 
Fig 4a Planning of the Osteotomy Guides 
Fig 4b Use of the osteotomy guides and application of the corresponding plates for the correction resulting from virtual planning. Patient Specific Procedures in CMF: State of the Art
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