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

NCT ID: NCT06046404

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-08

Study Completion Date

2025-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

cluster randomization

Study Groups

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closed reduction followed by plaster casting

Group Type ACTIVE_COMPARATOR

closed reduction

Intervention Type PROCEDURE

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.

only plaster casting

no closed reduction will be performed

Group Type EXPERIMENTAL

no closed reduction

Intervention Type PROCEDURE

no reduction will be performed

Interventions

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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.

Intervention Type PROCEDURE

no closed reduction

no reduction will be performed

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maasstad Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maasstad Hospital

Rotterdam, Maasstadweg 21, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Bas M Derksen, MsC

Role: CONTACT

0031618027390

Facility Contacts

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Bas M Derksen, MsC

Role: primary

+31618027390

Other Identifiers

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L2022093

Identifier Type: -

Identifier Source: org_study_id

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