Workflow assessment as a preclinical development tool : Surgical process models of three techniques for minimally invasive cochlear implantation.

PURPOSE: Minimally invasive cochlear implant surgery is a challenging procedure due to high demands on accuracy. For clinical success, an according assistance system has to compete against the traditional approach in terms of risk, operating time and cost. It has not yet been determined what kind of system is the most suited. The purpose of this study is a proof of concept of surgical process modeling as a preclinical development tool and the comparison of workflow concepts for this new approach. METHODS: Three preclinical systems (two stereotactic and one robotic) for minimally invasive cochlear implant surgery are compared using the method of surgical process modeling. All three systems were successfully tested with ex vivo human specimen to create minimally invasive surgical access to the cochlea. Those systems where chosen for comparison, because they represent three diverse approaches with different corresponding workflows for the same intervention. The experiments were used to create a process model for each system by recording the interventions. RESULTS: All three conceptual systems developed by our group have shown their eligibility. The recorded process models provide a convenient method for direct comparison. Reduction in the surgical time has a higher impact on the process, than time that is needed for setting up a system beforehand. The stereotactic approaches have little preparation effort and are low cost in terms of hardware compared to the robotic approach, which in return is beneficial in terms of workload reduction for the surgeon. CONCLUSION: Surgical process modeling is suitable for comparison of different assistant systems for minimally invasive cochlear implantation. The benefit of reduced trauma, compared to the traditional mastoidectomy, can now be assessed with consideration of the workflow of each technique. The process models enable an assessment in the regard of surgical time and workload.

Patient specific pointer tool for corrective osteotomy: Quality of symmetry based planning and case study of ulnar reconstruction surgery.

Malunion after forearm fractures are described to appear in 2% to 10% of cases. Reconstructive surgeries ensure adequate anatomical repositioning. Their importance derives from the fact that malunion can often lead to severe pain as well as deformities causing loss of function and aesthetic issues not only in the forearm, but also the wrist and elbow joint. In this paper a clinical case will be presented using a Patient Specific Instrument (PSI) as navigational aid for reconstructive surgery after malunion of a proximal ulnar fracture combined with allograft surgery of the radial head and radial condyle due to chronic traumatic radial head luxation (Monteggia fracture). A planning method based on symmetry is described and evaluated on twelve Computed Tomographic (CT) data sets of intact forearms. The absolute point to point deviation at distal end of the ulnar styloid process was used as a characteristic value for accuracy evaluation. It is 7.9±4.9mm when using only the proximal end of the ulna for registration. The simulated change of ulnar variance is -1.4±1.9mm. Design and concept of the PSI are proven in a clinical trial.

Design considerations for patient-specific surgical templates for total hip arthroplasty with respect to acetabular cartilage.

Patient-specific instruments (PSIs) are clinically used to support the surgeon during a planned intervention. The planning is typically done based on volumetric image data from medical imaging systems, e.g. computed tomography (CT). The PSI uses the known surface structure of a bone for orientation during the intervention. Some surfaces of human bone are covered with a layer of cartilage which is hardly visible in clinically applied CT-imaging. This experimental study investigates ten different PSI designs and their effect to the overall accuracy when neglecting the cartilage in the design process. Therefore, a model of an acetabulum is used to simulate the use case of PSI in total hip arthroplasty. The concept of the different designs is to create structural elasticities in the PSI to avoid shifting of the whole instrument and rather have a small part of it deformed by cartilage. A needle array structure, for instance, should also be able to oust or penetrate remaining soft tissue in the acetabulum.