NCT06046404

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 15, 2025

Status Verified

September 1, 2024

Enrollment Period

2 years

First QC Date

September 8, 2023

Last Update Submit

May 12, 2025

Conditions

Wrist FracturesDistal Radius FracturesClosed Reduction of Fracture and Application of Plaster CastWrist InjuriesRadius Fracture Distal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • function

    6 weeks, 3, 6 and 12 months

  • Number of complications

    1 year

  • Wrist mobility

    6 weeks and 3 months

  • length of stay in emergency department

    baseline

  • quality of life in EQ5D5L

    1 year

Study Arms (2)

closed reduction followed by plaster casting

ACTIVE COMPARATOR
Procedure: closed reduction

only plaster casting

EXPERIMENTAL

no closed reduction will be performed

Procedure: no closed reduction

Interventions

closed reductionPROCEDURE

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.

closed reduction followed by plaster casting
no closed reductionPROCEDURE

no reduction will be performed

only plaster casting

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • displaced distal radial fracture eligible for surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maasstad Hospital

Rotterdam, Maasstadweg 21, 3079 DZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Wrist FracturesWrist Injuries

Interventions

Closed Fracture Reduction

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeutics

Central Study Contacts

Bas M Derksen, MsC

CONTACT

0031618027390DerksenB@maasstadziekenhuis.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
cluster randomization
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 21, 2023

Study Start

May 8, 2023

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

May 15, 2025

Record last verified: 2024-09

Locations

NL(1)