Orthopaedic SurgeryNCT06309784
Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
A study testing Drill Guidance System (DGS) in people with Orthopaedic Surgery, run by Royal United Hospitals Bath NHS Foundation Trust at 2 sites in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthopaedic Surgery
- What is being tested?
- Drill Guidance System (DGS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Mar 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Royal United hospitals NHS Foundation Trust
Bath
Great Western Hospital MHS foundation Trust
Swindon
About this study
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
Read the 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.
- Conditions
- Orthopaedic Surgery
- Being tested
- Drill Guidance System (DGS)
- Keywords
- orthopaedic, fracture, drill, screw, wire, accuracy
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drill Guidance System (DGS)Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Drill Guidance System (DGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (6)
Length of material part of the procedure
The length of time performing the part of the surgical procedure when the DGS is used. There are no baseline data against which to compare. This should give an indicator of speed/ease of use.
Measured: Duration of the operation
Number of fluoroscopy (perioperative X-ray) images performed
The number of fluoroscopy images performed peri-operatively whilst using DGS; for scaphoid fractures data will be compared with data from > 200 equivalent operations in the Scaphoid Waist internal fixation for fractures (SWIFFT) trial. For other operations the number of images taken when using the DGS will be recorded. There are no baseline data but the data can be used as an estimate of ease of use
Measured: Duration of the operation
Number of patients with treatment related adverse events as assessed by CTCAE v4.0
The key adverse events we will review:
Screw misplacement (prime complication).
- scaphoid fractures: when the screw is not in the central third of the scaphoid
- other operations: when the screw/wire tip (or its projection to the outer cortex of the bone) is outside the chosen limits - 2mm in either plane at a distance of 30mm.
Bone: Fracture mal-alignment post-operatively as shown on the initial post-operative radiographs and any subsequent radiographs/scans.
Soft tissue: Possible soft tissue complications e.g. infection, and nerve and tendon injury, will be sought and recorded in the clinical notes at each standard clinical appointment
Measured: WIthin 3 months of surgery (the planned follow-up period)
Immediate acceptability to surgeons and theatre staff
Following consent the surgeons and theatre staff will be asked to complete a short questionnaire after each operation.
Measured: 3 months, i.e. duration of the study
Initial acceptability to surgeons and theatre staff
After the first 5 operations there will also be a debrief in person to get immediate feedback
Measured: 3 months, i.e. duration of the study
Overall acceptability to surgeons and theatre staff
Qualitative data will be collected via two focus groups held either face to face at each site or via Teams to include surgeons and theatre staff. These will collect user views on ease of use, problems encountered and areas for improvement. The focus groups will be recorded to allow for transcription and analysis of themes after all participants have completed their initial operation. Attendance at these focus groups will be optional for theatre staff and consent will be sought
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start19 Mar 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Orthopaedic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants undergoing orthopaedic Surgery
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, Great Western Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Adam Smith, FRCS (T and O), Principal investigator, Great Western Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309784
- Sponsor's protocol ID
- RD 2595
- Other IDs
- NIHR II-LA-1116-20004
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30394951Brioschi 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.
PubMed 27547423Dias 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.
PubMed 32771106
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
- ClinicalTrials.gov ID
- NCT06309784
- Acronym / sponsor ID
- RD 2595
- Conditions
- Orthopaedic Surgery
- Keywords
- orthopaedic, fracture, drill, screw, wire, accuracy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bath, Great Western Hospitals NHS Foundation Trust
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants undergoing orthopaedic Surgery
| Arm | Type | Receives |
|---|---|---|
| Drill Guidance System | Experimental | Procedure: Drill Guidance System (DGS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Drill Guidance System |
Primary outcome
Accuracy of placement of a screw or K wire in scaphoid bones
Time frame: 3 months
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
Accuracy of placement of a screw or K wire in other bones
Time frame: 3 months
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
6 secondary outcomes
Length of material part of the procedure
Time frame: Duration of the operation
Number of fluoroscopy (perioperative X-ray) images performed
Time frame: Duration of the operation
Number of patients with treatment related adverse events as assessed by CTCAE v4.0
Time frame: WIthin 3 months of surgery (the planned follow-up period)
Immediate acceptability to surgeons and theatre staff
Time frame: 3 months, i.e. duration of the study
Initial acceptability to surgeons and theatre staff
Time frame: 3 months, i.e. duration of the study
Overall acceptability to surgeons and theatre staff
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 30394951Langeveld 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.
- Background: PubMed 27547423Brioschi 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.
- Results publication: PubMed 32771106Dias 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Smith, FRCS (T and O) principal investigator
Great Western Hospitals NHS Foundation Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drill Guidance System (DGS) in people with Orthopaedic Surgery, run by Royal United Hospitals Bath NHS Foundation Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of placement of a screw or K wire in scaphoid bones (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06309784, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.