Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-28 @ 11:09 AM
Study NCT ID:
NCT06046404
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Sponsor:
Maasstad Hospital
Organization:
Study Overview
Official Title:
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Status:
RECRUITING
Status Verified Date:
2024-09
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:
RECORDED
Brief Summary:
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.
Detailed Description:
in a multicenter cluster randomized trial the investigators aim to include 134 patients with displaced distal radial fractures awaiting surgery and randomize between closed reduction followed by plaster casting and plaster casting alone. Primairy outcomes are pain in the days leading up to surgery and postoperative hand- and wrist function. Secondary outcomes are length of stay in the emergency department, length of surgey, return to work and complications.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: