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

May 7, 2026 updated by: Maasstad Hospital
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

147

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Maasstadweg 21
      • Rotterdam, Maasstadweg 21, Netherlands, 3079 DZ
        • Maasstad Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: closed reduction followed by plaster casting
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.
Experimental: only plaster casting
no closed reduction will be performed
Procedure: no closed reduction
no reduction will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
daily pain scores
Time Frame: 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.
usually 2-10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
function
Time Frame: 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.
6 weeks, 3, 6 and 12 months
Number of complications
Time Frame: 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.
1 year
Wrist mobility
Time Frame: 6 weeks and 3 months
Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.
6 weeks and 3 months
length of stay in emergency department
Time Frame: baseline
length of stay in emergency department
baseline
quality of life in EQ5D5L
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maasstad Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Actual)

May 23, 2025

Study Completion (Actual)

May 23, 2025

Study Registration Dates

First Submitted

September 8, 2023

First Submitted That Met QC Criteria

September 18, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2022093

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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