Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-19

Study Completion Date

2024-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Orthopaedic Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants undergoing orthopaedic Surgery

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drill Guidance System

Using a camera based system attached to a standard surgical drill the operating surgeon will use the DGS to drill with the aim of making the drilling more accurate.

Group Type EXPERIMENTAL

Drill Guidance System (DGS)

Intervention Type PROCEDURE

During a standard surgical procedure where a drill/k wire is being inserted the surgeon may choose (in advance) to supplement their drilling with use of the Drill Guidance System. This will be a supplement to normal practice. it is anticipated it will make surgery more accurate, swifter and safer. If however the surgeon is not finding the DGS useful it can be abandoned and standard drilling with X-ray guidance used

Interventions

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Drill Guidance System (DGS)

During a standard surgical procedure where a drill/k wire is being inserted the surgeon may choose (in advance) to supplement their drilling with use of the Drill Guidance System. This will be a supplement to normal practice. it is anticipated it will make surgery more accurate, swifter and safer. If however the surgeon is not finding the DGS useful it can be abandoned and standard drilling with X-ray guidance used

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* adults, i.e. 18 years or over;
* awaiting orthopaedic or trauma surgery;
* have capacity to consent to participate in the study
* the proposed operation is deemed to be appropriate by the treating Orthopaedic surgeon for use of the DGS

Exclusion Criteria

* children, i.e. \< 18 years of age
* the patient is unable to give informed consent;
* the surgeon does not feel able to use the DGS
* the surgeon does not feel use of the DGS is appropriate for the type of surgery required

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes