Title: Robot-assisted fracture surgery (RAFS)
Funder: Department of Health (England)

Abstract: Over the 36 month (M) period we will undertake the following tasks to meet the objectives listed above: Objective 1: - 1.1 Market Research and confirm users’ requirements and design specifications (M1-M3). We will prepare a user-requirement specification which will serve as an essential part of the design and development phase. This will determine what the end-user would expect from the device - how it could be used, key performance requirements, the preferred interface, the size of the device, materials and sterilisation requirements, consumables requirements. - 1.2 Design and build robotic devices (M3-M18) For the proof-of-concept to-date we have used only commerically available components. To build compact robots that can be easily integrated in operating theatres, we will design and manufacture fit-for-purpose linear actuators of specific size and motion characteristics. The system requires high accuracy and repeatability that can not be currently found on the market.This is a critical part of the work to ensure accurate performance of the system. Objective 2 : System Integration - a successful joint reduction procedure is determined among other things by the relative positional accuracy ( Interfacing the surgeon console with the robot console Interfacing the 3D navigation to the robotic system Implementation of the control on the robotic hardware Hybrid controller efficiency Objective 3: 3.1 This validation phase is critical to prove that we can achieve the set positional accuracy of the integrated system on commercial bone models. In the second part we will test compensation of forces posed by the soft tissue in the joint. Knee joint models are commecially available and will enable us to mimic fractures and soft tissue characteristics in laboratory . Our validation will be made on 3 types of 3 part fractures of the distal femur. Positional accuracy of reduction will be assessed using a high resolution camera in the laboratory (without the soft tissue) and using a CT scan (with the soft tissue). 3.2 System optimisation : In preparation for cadaver studies, the robotic system will be optimised to provide the required positional accuracy while keeping forces within the prescribed limits. At this stage we expect that mainly software and the developed interfaces will need updating and that the main hardware components will be firmly established with the Objective 1. Objective 4 : This validation stage in cadaveric models will be based on the same types of fractures as the laboratory validation. Southwest RDS (dr Rosemary Greenwood) has provided us with an optimal number of cadaveric models required for this study. Results have to satisfy the user requirements specifications. Effect on the surrounding tissue will be assessed by the clinical team. Objective 5 : Complete Health Ecomonics reveiw and compilation of business and commercialisation plan. The Health Ecomonic study will be sub-contracted and will feed into the business and commercialisation plan document that will be completed during the last milestone. It will include the market research report, competitor analysis, IP portfolio description, revised FTO search, requirement specifications, project technical file, a suggested regulatory strategy, post project development requirements, potential licensees/development partners, follow-on funding strategy, technology, platform product road map and an assessment of route to market options.


Research activity codes: 5.4 SURGERY;5.3 MEDICAL DEVICES
Health categories: INJURIES AND ACCIDENTS