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

NCT06309784 | Completed DMC

• 2 other identifiers: RD 2595NIHR II-LA-1116-20004
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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

Conditions

Orthopaedic Surgery

Keywords

orthopaedic; fracture; drill; screw; wire; accuracy

Outcome Measures

Primary Outcomes (2)

• Accuracy of placement of a screw or K wire in scaphoid bones

  1.Scaphoid fractures: "best practice" is screw placement in the central third of the scaphoid. This has been defined using CT scans in the Scaphoid Waist Internal Fixation for Fractures (SWIFFT) trial. When fixing a scaphoid fracture the surgeon will aim to place the screw in the central third of the scaphoid (standard) unless otherwise recorded. The screw position will be measured as central or off-centre (as in SWIFFT trial). The data from the SWIFFT trial will be used as a benchmark Measurements will be made with the computer measuring system on the Patient Archiving Communication System

  3 months

• Accuracy of placement of a screw or K wire in other bones

  Other fractures: at the point the surgeon plans to drill for the material screw/wire they will declare the planned exit point of the screw/wire using x and y co-ordinates in mm relative to a defined bony landmark prior to the use of the Drill Guide System. The screw/wire position on post-operative CT scans will be defined by the position of the tip of the screw/wire (or its projection to the outer cortex of the bone if it does not reach). This will be compared to the planned exit point to give distance and vector measurements Measurements will be made with the computer measuring system on the Patient Archiving Communication System

  3 months

Secondary Outcomes (6)

• Length of material part of the procedure

  Duration of the operation

• Number of fluoroscopy (perioperative X-ray) images performed

  Duration of the operation

• Number of patients with treatment related adverse events as assessed by CTCAE v4.0

  WIthin 3 months of surgery (the planned follow-up period)

• Immediate acceptability to surgeons and theatre staff

  3 months, i.e. duration of the study

• Initial acceptability to surgeons and theatre staff

  3 months, i.e. duration of the study

Study Arms (1)

Drill Guidance System

EXPERIMENTAL

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.

Procedure: Drill Guidance System (DGS)

Interventions

Drill Guidance System (DGS) 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

Drill Guidance System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator
• Great Western Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Royal United hospitals NHS Foundation Trust

Bath, United Kingdom

Location

Great Western Hospital MHS foundation Trust

Swindon, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30394951 BACKGROUND

• 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.

  PMID: 27547423 BACKGROUND

• 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.

  PMID: 32771106 RESULT

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Adam Smith, FRCS (T and O)

  Great Western Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants undergoing orthopaedic Surgery

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: March 13, 2024
• Study Start: March 19, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 22, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)