Clinical trial NCT06309784: Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
Official title: Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopaedic Surgery
Keywords: orthopaedic
fracture
drill
screw
wire
accuracy
Lead sponsor: Royal United Hospitals Bath NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Bath
name: Great Western Hospitals NHS Foundation Trust
First posted: 2024-03-13
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants undergoing orthopaedic Surgery
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of placement of a screw or K wire in scaphoid bones
timeFrame: 3 months
measure: Accuracy of placement of a screw or K wire in other bones
timeFrame: 3 months
Secondary outcomes:
measure: Length of material part of the procedure
timeFrame: Duration of the operation
measure: Number of fluoroscopy (perioperative X-ray) images performed
timeFrame: Duration of the operation
measure: Number of patients with treatment related adverse events as assessed by CTCAE v4.0
timeFrame: WIthin 3 months of surgery (the planned follow-up period)
measure: Immediate acceptability to surgeons and theatre staff
timeFrame: 3 months, i.e. duration of the study
measure: Initial acceptability to surgeons and theatre staff
timeFrame: 3 months, i.e. duration of the study
measure: Overall acceptability to surgeons and theatre staff
timeFrame: 3 months
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United hospitals NHS Foundation Trust
city: Swindon
country: United Kingdom
facility: Great Western Hospital MHS foundation Trust
Study officials:
affiliation: Great Western Hospitals NHS Foundation Trust
name: Adam Smith, FRCS (T and O)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langeveld ARJ, Rustenburg CME, Hoozemans MJM, Burger BJ, Meuffels DE. To Improve Your Surgical Drilling Skills, Make Use of Your Index Fingers. Clin Orthop Relat Res. 2019 Jan;477(1):232-239. doi: 10.1097/CORR.0000000000000557.
citation: Brioschi V, Cook J, Arthurs GI. Can a surgeon drill accurately at a specified angle? Vet Rec Open. 2016 Jul 14;3(1):e000172. doi: 10.1136/vetreco-2016-000172. eCollection 2016.
citation: Dias JJ, Brealey SD, Fairhurst C, Amirfeyz R, Bhowal B, Blewitt N, Brewster M, Brown D, Choudhary S, Coapes C, Cook L, Costa M, Davis T, Di Mascio L, Giddins G, Hedley H, Hewitt C, Hinde S, Hobby J, Hodgson S, Jefferson L, Jeyapalan K, Johnston P, Jones J, Keding A, Leighton P, Logan A, Mason W, McAndrew A, McNab I, Muir L, Nicholl J, Northgraves M, Palmer J, Poulter R, Rahimtoola Z, Rangan A, Richards S, Richardson G, Stuart P, Taub N, Tavakkolizadeh A, Tew G, Thompson J, Torgerson D, Warwick D. Surgery versus cast immobilisation for adults with a bicortical fracture of the scaphoid waist (SWIFFT): a pragmatic, multicentre, open-label, randomised superiority trial. Lancet. 2020 Aug 8;396(10248):390-401. doi: 10.1016/S0140-6736(20)30931-4.