This multicentre randomised controlled trial aims to investigate whether PoCUS can be used as an adjunct to improve first attempt success rate in closed reductions of displaced distal radial fractures in adults in the ED.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Health condition
Distal radius fracture
Research involving
Sponsors and support
Intervention
- Medical device
Outcome measures
Primary outcome
A 50% reduction in repeated reduction attempts of distal radius fractures between the ultrasound guided group and the control group.
Secondary outcome
The difference between both groups in the number of patients that need reduction in operating theater, the difference in reduction time in ED between both groups.
Background summary
During closed reduction of displaced distal radial fractures, physicians have to rely on physical examination to determine the need for further reduction before cast application. Point-of-care ultrasound (PoCUS) has the potential to inform physicians about the outcome of the reduction even before obtaining a post-reduction X-ray or cast application. This may decrease the number of reduction attempts.
Study objective
This multicentre randomised controlled trial aims to investigate whether PoCUS can be used as an adjunct to improve first attempt success rate in closed reductions of displaced distal radial fractures in adults in the ED.
Study design
Multicentre randomised controlled trial
Intervention
Ultrasound
Study burden and risks
The use of ultrasound does not cause any risk for patients included.
Age
Inclusion criteria
Patients more than 16 years of age with a distal radius fracture (including intra-articular fractures or in combination with a distal ulna fracture) with significant displacement that requires reduction.
Exclusion criteria
Age <16 years, open fractures, new neurovasculair damage, operation indication based on first X-ray, osteosynthesis material in fractured wrist, a reason that makes it impossible to applicate ultrasound gel.
Design
Recruitment
IPD sharing statement
Postbus 888
8901 BR Leeuwarden
058 286 1151
RTPO@mcl.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7934 |
| Other | METC MCL, METC Isala, METC UMCG : Not-WMO, RTPO 1050 |