The 36-month project is formed of three high-level work areas; System development, Trials and Data Gathering and Commercialisation. System development (University of Bath) This work package comprises the technical development work, as well as the definition of the system requirements. It will be led by the University of Bath with input from surgeons and patients and oversight from i2r Medical to ensure standards compliance. Following a rigorous requirement specification definition, the development work has 4 stages, each with a corresponding stage-gate review point and a go/no-go decision: WP1.2 Core software development (3 months) Core tracking algorithms to be implemented and validated against relevant requirement specifications. This step mitigates the biggest technical risk: that the proposed method cannot produce the required target tracking accuracy. WP1.3 Lab bench prototyping (2 months) The first complete device will be evaluated in the lab as the Mk1 prototype. This stage will be used to optimise design details and identify areas for improvments in preparation for the final design work. WP1.4-1.8 User interface, electronic hardware and mechanical design, integration, and verification tests (4 months) The intended design will be finalised and used for the first rigorous verification against the specification. (Mk 2 prototype) WP1.9-1.12 Production development, Validation Testing & Prototype Mk 3 manufacture (5.5 months) The Mk2 prototype will be refined and readied for a limited production run and the final Mk3 device will be tested to ISO/IEC standards and undergo sterile validation. Trials and Data Gathering (University of Bath & Royal United Hospital) This work package comprises clinical and non-clinical testing, including control case data capture, phase 1 (non-clinical) device testing, and phase 2 clinical investigations. The work package covers the ethics and MHRA approvals, and the development of X-ray protocols and outome measures to ensure relilable quantitative data are gathered to assess the proposed device's performance. WP2.1.1-2.1.8 X-ray protocol & Outcome measures, and baseline data capture (10 months) The X-ray protocol and outcome measures are essential to the quantitative anaylsis of the clinical investigation, to ensure data is captured in a repeatable fashion and the results are comparable. These techniques will be developed and used to gather baseline datasets as control cases for the clinical investigation. WP2.2-2.5 Phase 1 trial (8 months) The phase 1 trial will be comprised of non-clinical investigations into the accuracy of surgical operations in synthetic bones. Orthopaedic surgeons will be invited to conduct the trials under simulated clinical conditions, and the resulting accuracy of the operations will be compared with and without using the DGS. WP2.6-2.11 Phase 2 clinical investigation (18 months) A surgeon will be able to use the device in addition to the usual equipment, to augment the process, and the results can be compared to those from the baseline data capture. Key measures of success include the time spent in theatre, the number of drilling attempts required, the number of X-rays required, the results of the outcome measures developed in WP2.1.6-2.1.8, and the survey results from patients, surgeons and theatre staff. Commercialisation Development (University of Bath and Royal United Hospital) The purpose of the project is to develop the technology to the point where it is ready for CE marking and full-scale industrial manufacture. These work packages will seek to exploit industry contacts at the University of Bath and the Royal United Hospital to secure a partner who will exploit the technology. Drawing on resource impact projections from a health economist, and a resulting adoption plan for the NHS, a business case and a commercialisation plan will be drawn up to ensure the continued development of the device beyond the end of this project.
When drilling into bones, surgeons attempt to make the first drill pass the only drill pass. But they are dealing with complex 3 -dimensional shapes with limited access due to the soft tissues. They often have to re-drill holes to make them as accurate as possible. Often many attempts are required, making the process time consuming, potentially damaging to the soft tissue and bone and resulting in excessive removal of material from the bone. Eventually the surgeon may accept a sub-optimal position as repeat drilling becomes harder as the drill tends to go down previous holes. We are developing a Drill Guidance System to help surgeons drill into bones correctly at the first attempt, which will reduce the time taken for the operation, improve quality of patient care and make surgical training safer and easier as the drilling will be more accurate. The system is being developed by a team of engineers from the University of Bath and a surgeon from the Royal United Hospital. We intend to perform two trials to test the system. The first trial will not involve patients, but will prove the accuracy of the new system by having surgeons drill through bone-like material. The second trial will involve using the system on patients who require holes drilled as part of surgery, for example when inserting a screw to fix a break in a bone. Patients with a broken arm, wrist or ankle may be eligible to take part in this study. This will depend on their specific case, as not all types of broken bone require surgery. Using the system will not change the surgical approach, but should improve the outcomes and prove the safety and performance. The trial will run for 8 months in late 2020.