Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department

Not Applicable

Recruiting

• Conditions: Closed Reduction of Fracture and Application of Plaster Cast; Wrist Fractures; Distal Radius Fractures; Wrist Injuries; Radius Fracture Distal
• Interventions: Procedure: closed reduction; Procedure: no closed reduction

• Registration Number: NCT06046404
• Lead Sponsor: Maasstad Hospital

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 Timeline

• Study Start: 2023-05-08
• Study First Submitted: 2023-09-08
• Study First Submitted QC: 2023-09-18
• Study First Posted: 2023-09-21
• Status Verified: 2024-09
• Primary Completion: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

Inclusion Criteria

• displaced distal radial fracture eligible for surgery

Exclusion Criteria

• ISS traumascore >16
• open fracture
• multiple fractures in ipsilateral extremety
• neurovascular damage
• previous injury in the same wrist
• inability to complete questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
closed reduction followed by plaster casting	closed reduction	-
only plaster casting	no closed reduction	no closed reduction will be performed

Primary Outcome Measures

Name	Time	Method
daily pain scores	usually 2-10 days	pain reported in the days awaiting surgery on the visual analog scale (VAS) scoring from 0 to 10 where 0 equals no pain and 10 the worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Number of complications	1 year	The investigators will report all complications including, but not limited to: nerve damage, CRPS, infection, bleeding, malunion and need for revision surgery will be tracked.
function	6 weeks, 3, 6 and 12 months	hand function as reported by the patient reported hand and wrist evaluation (PRHWE) questionnaire. scoring from 0 to 100 with 0 meaning perfect function with no impairment or pain and 100 meaning no function at all with maximum pain.
Wrist mobility	6 weeks and 3 months	Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.
quality of life in EQ5D5L	1 year	reported by the EQ5D5L questionnaire. EQ-5D-5L health states can be summarised using a 5-digit code or represented by a single summary number (index value), which reflects how good or bad a health state is according to the preferences of the general population of a country/region.
length of stay in emergency department	baseline	length of stay in emergency department

Trial Locations

Locations (1)

Maasstad Hospital; 🇳🇱 Rotterdam, Maasstadweg 21, Netherlands