Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06309784
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-09
Brief Title:
Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
Sponsor:
Royal United Hospitals Bath NHS Foundation Trust
Organization:
Royal United Hospitals Bath NHS Foundation Trust
Study Overview
Official Title:
Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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 screwwire 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
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 ie 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 screwwire 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIHR II-LA-1116-20004 | OTHER_GRANT | NIHR | None |