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

Royal United Hospitals Bath NHS Foundation Trust

Status: Completed

Conditions: Orthopaedic Surgery

Treatments: Procedure: Drill Guidance System (DGS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06309784

RD 2595

NIHR II-LA-1116-20004 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Drill Guidance System

Experimental group

Description:

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.

Treatment:

Procedure: Drill Guidance System (DGS)