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The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess: Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff
This project is a collaboration between the Royal United Hospitals Bath and the Department of Mechanical Engineering at the University of Bath in the development of a drill guidance system to aid intra-operative surgical drilling in Orthopaedic and trauma surgery. The types of operation will include drilling into bones to place screws or wires to develop a track for passage of a screw, suture or other material. The project has been funded by an National Institute for Health Invention for Innovation Grant (NIHR i4i) over 3 years. The Drill Guide System (DGS) has been developed so it can be attached to a surgical drill with the overall aim of improving the accuracy of surgical drilling of holes in bones. The drilling will be performed as standard, i.e. as required for any specific operation. The drill guide will be an adjunct to visual observation by the surgeon and fluoroscopy (peri-operative radiographs - X-rays). The surgeon can decide to not use the drill guide if it is considered to be hampering the operation. A camera and computer based system attached to a surgical drill will be used to improve drilling accuracy in an operating theatre The Drill Guidance system has undergone rigorous testing and various laboratory trials with surgeons and operating staff as part of development of the design. The final prototype will be used as part of a wider clinical trial involving Orthopaedic Surgeons at the Royal United Hospitals Bath and the Great Western Hospital, Swindon (within the NHS) to test the efficacy and value of the system during surgery. The Investigators intend to recruit up to 30 surgical patients as part of the trial from two sites. Background: It is recognised clinically and in laboratory studies that "freehand" drilling has appreciable inaccuracies. This risks misplacement of screws potentially compromising surgical outcome and increasing the risk of complications. Furthermore, inaccurate initial drilling can lead to inaccurate subsequent drilling and so suboptimal positioning of the screw/wire with potential adverse outcomes and increased costs. The screw may be placed and then have to be changed. A new different length screw may be required with the first screw discarded with further costs.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Royal United hospitals NHS Foundation Trust
Bath, United Kingdom
Great Western Hospital MHS foundation Trust
Swindon, United Kingdom
Start Date
March 19, 2024
Primary Completion Date
December 31, 2024
Completion Date
December 31, 2024
Last Updated
January 22, 2025
19
ACTUAL participants
Drill Guidance System (DGS)
PROCEDURE
Lead Sponsor
Royal United Hospitals Bath NHS Foundation Trust
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT03481439