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

M

Maasstad Hospital

Status

Enrolling

Conditions

Wrist Injuries
Distal Radius Fractures
Closed Reduction of Fracture and Application of Plaster Cast
Radius Fracture Distal
Wrist Fractures

Treatments

Procedure: closed reduction
Procedure: no closed reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT06046404
L2022093

Details and patient eligibility

About

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

Full 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.

Enrollment

134 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

closed reduction followed by plaster casting
Active Comparator group
Treatment:
Procedure: closed reduction
only plaster casting
Experimental group
Description:
no closed reduction will be performed
Treatment:
Procedure: no closed reduction

Trial contacts and locations

1

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Central trial contact

Bas M Derksen, MsC

Data sourced from clinicaltrials.gov

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