Development of a drill guide system to aid intra-operative drilling
Research type
Research Study
Full title
Development of a drill guide system to aid intra-operative surgical drilling
IRAS ID
308347
Contact name
Grey Giddins
Contact email
Sponsor organisation
Royal United Hospitals Bath NHS FT
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
This is a trial of a new medical device, funded by an NIHR i4i grant as a collaboration between the Royal United Hospitals (RUH) Bath NHS FT and the University of Bath. A Drill Guidance system (DGS) has been developed that attaches to a surgical drill and also includes a probe to align the end of the drill tip and electronically display the position of the drill bit to give surgeon feedback. The camera feeds graphics of the drill position to a display screen visible to the surgeon. The DGS will be used by a surgeon in the operating theatre with the aim of improving drilling accuracy into the bone. The DGS has already been tested rigorously in lab based trials with surgeons/operating staff at RUH Bath to assess usability and accuracy.
The principal study aim is to test the efficacy of the DGS in the operating theatre. It is hoped that the DGS will improve the accuracy of the surgical procedure which will benefit patients, reduce surgery time and the number of standard care fluoroscopy x-ray images performed perioperatively and by improving accuracy reduce surgical complications.
We aim to recruit 30 patients from the RUH and Great Western Hospital (GWH) Swindon who are awaiting orthopaedic surgery. There are minimal time commitments for the patient other than consent, completion of patient reported outcome measures (PROMs) and post operative discussion with the surgical team which are part of standard care.
There is a plan to commercialise in the future.Surgeons and Operating Theatre staff will also be recruited to the trial so that their feedback on the use of the DGS system can be obtained. Acceptability and improvement ideas for the DGS will be fed back through staff questionnaires post surgery and via focus groups.
REC name
London - Dulwich Research Ethics Committee
REC reference
23/LO/0317
Date of REC Opinion
24 Apr 2023
REC opinion
Favourable Opinion