College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
College - Author 2
College of Engineering
Department - Author 2
Biomedical Engineering Department
Degree - Author 2
BS in Biomedical Engineering
College - Author 3
College of Engineering
Department - Author 3
Biomedical Engineering Department
Degree - Author 3
BS in Biomedical Engineering
Date
6-2024
Primary Advisor
Britta Berg-Johansen, College of Engineering, Biomedical Engineering Department
Abstract/Summary
Kinomatic is a startup company that provides custom preoperative surgical plans for orthopedic surgeons. The surgical plans are intended for total hip and knee arthroplasty to provide patient-specific measurements and implant sizing. Surgeons can view the surgical plans as 3D models in virtual reality with an Oculus Quest 2 headset or as a PDF summary. Most patients receive a diagnostic anterior-posterior (AP) x-ray that allows their surgeon to determine if they are eligible for a total hip or knee replacement. After diagnosis, the patient can also choose a Kinomatic surgical plan to provide their surgeon with additional data points before entering the operating room. Kinomatic constantly seeks to advance its products by providing surgeons with additional preoperative measurements and data. The measurement of pelvic tilt related to cup placement for total hip arthroplasty has been proposed as a need for Kinomatic surgeons. Kinomatic is dedicated to enhancing surgical outcomes through innovative technologies and ongoing research, ensuring patients and surgeons have access to the most accurate and comprehensive preoperative data for successful joint replacement procedures. This project will affect the following stakeholders: Kinomatic, Kinomatic’s orthopedic surgeons, and Kinomatic total hip arthroplasty patients.
The design process included receiving customer requirements from Kinomatic, translating the customer requirements into engineering specifications with measurable outcomes, researching possible ways to measure pelvic tilt, creating an x-ray image acquisition process, creating a semiautomated macro to measure pelvic tilt, and validating all engineering specifications. As the project unfolded, several engineering specifications were updated to reflect Kinomatics needs. A major change was adding pelvic tilt measurements in three planes instead of one. The first key engineering specification was to measure the discrepancy between pelvic tilt measurements on a 2D weight bearing x-ray vs. Kinomatic’s 3D supine model. The second key specification was ensuring the measurements were not obscured by pelvic or spine pathologies. The third key specification was that the measurement process is semi automated with a SolidWorks macro.
A sample size rationale determined that 22 patients were necessary to conclude proper validation of the process. However, due to limited availability of patients, only 2 x-rays have been received. The measurements were validated with a tolerance of ±2° and each patient was tested 5 times to ensure reliability of the semi automated macro. Kinomatic plans to continue the project until the measurements are validated for the sample size. See the Testing Data and Analyses section for specific testing outcomes. Almost all tests passed except for including the measurements on the surgical plans. Once the measurements are validated, Kinomatic will add the measurements to the VR and PDF surgical plans.
This Final Report includes a Background section describing similar products in the industry, related technical literature, and industry regulations. Third is an Objectives section, including a problem statement, a boundary definition, indications for use, customer requirements, a Quality Function Deployment with a House of Quality, and an Engineering 3 Specifications Table. Fourth is a Project Management section with the overall design process, a summary of deliverables, a project timeline, unique techniques, a Gantt Chart, and next steps. Fifth, there is a Conceptual Design section with a Morphology, Concept Evaluation with Pugh Matrices, a Conceptual Model, Failure Mode and Effects Analysis (FMEA). Sixth, there is a Detailed Design section with a front runner design, final design, and design drawings. Seventh there is a Process Instructions section with instructions for image acquisition based on x-ray protocols. There are also detailed instructions for Pelvic Tilt, Pelvic Obliquity, and Axial Rotation measurements on an AP x-ray and on a 3D model. There is also a design hazards checklist and sample size rationale. Eighth there is a Test Plan section with a summary table of test plans and description of each test plan. Ninth there is a summary of Testing Data and Analyses. Tenth, there is an Instructions for Use for surgeons to use the new measurements. Lastly, this Final Report includes an outline of Future Steps, Conclusion, References, and Appendices.
URL: https://digitalcommons.calpoly.edu/bmedsp/196