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

Distal Radius Fractures Clinical Trial

— RECORDED  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046404
• Other study ID #: L2022093
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Maasstad Hospital
• Contact: Bas M Derksen, MsC
• Phone: 0031618027390
• Email: DerksenB[@]maasstadziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Distal Radius Fractures
• Emergencies
• Fractures, Bone
• Radius Fracture Distal
• Radius Fractures
• Wrist Fractures
• Wrist Injuries

Intervention

Procedure:
• closed reduction
the intervention of closed fracture reduction widely known and part of daily practice. we test the eficacy of this intervention by not performing it in our test group.
• no closed reduction
no reduction will be performed

Locations

Country	Name	City	State
Netherlands	Maasstad Hospital	Rotterdam	Maasstadweg 21

Sponsors (1)

Lead Sponsor	Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	daily pain scores	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.	usually 2-10 days
Secondary	function	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.	6 weeks, 3, 6 and 12 months
Secondary	Number of complications	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.	1 year
Secondary	Wrist mobility	Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.	6 weeks and 3 months
Secondary	length of stay in emergency department	length of stay in emergency department	baseline
Secondary	quality of life in EQ5D5L	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.	1 year