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CompletedNCT06046404RECORDEDUpdated May 12, 2026

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

An interventional study of closed reduction and no closed reduction in Wrist Fractures, Distal Radius Fractures and Closed Reduction of Fracture and Application of Plaster Cast, sponsored by Maasstad Hospital. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-12.

Sponsored by Maasstad Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Wrist Fractures with a site in Netherlands — 2 open to participants now, 3 under way, none of them phase 3. Wrist Fractures · Netherlands.

Enrollment
Largest of 11
147 · median 86
Started
2023
with 1 other
No phase
10 of 13
2 open now
Registered
11th of 13
by date
Lead sponsor
2 of 13
Maasstad Hospital

Among the 13 studies in Wrist Fractures with a site in Netherlands, this one has the largest enrollment of the 11 interventional ones, is one of 2 that started in 2023, is one of 10 with no phase, and was the 11th registered.

By phase

13 studies; the count open now beside each. This study's row is marked.

No phasethis study10 · 2 open
Observational2 · 0 open
Phase 21 · 0 open

By the year they started

First in 2007; this study’s year is marked. 2 started in 2023.

What they test

Size and results

Median enrollment 86 across the 11 interventional studies, 850 across the 2 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 13 studies in Wrist Fractures with a site in Netherlands, or all of them as a file.
02

Study summary

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

Read the 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.

03

Conditions studied

  • Wrist Fractures
  • Distal Radius Fractures
  • Closed Reduction of Fracture and Application of Plaster Cast
  • Wrist Injuries
  • Radius Fracture Distal
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • displaced distal radial fracture eligible for surgery

Exclusion criteria

Exclusion Criteria:

  • ISS traumascore >16
  • open fracture
  • multiple fractures in ipsilateral extremety
  • neurovascular damage
  • previous injury in the same wrist
  • inability to complete questionnaires
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • Active comparator
    closed reduction followed by plaster casting

    Procedure: closed reduction

  • Experimental
    only plaster casting

    no closed reduction will be performed

    Procedure: no closed reduction

Interventions

  • Procedureclosed 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.

  • Procedureno closed reduction

    no reduction will be performed

06

What researchers measure

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.

    Time frame: usually 2-10 days

Secondary outcomes

  1. 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.

    Time frame: 6 weeks, 3, 6 and 12 months

  2. 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.

    Time frame: 1 year

  3. Wrist mobility

    Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.

    Time frame: 6 weeks and 3 months

  4. length of stay in emergency department

    length of stay in emergency department

    Time frame: baseline

  5. 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.

    Time frame: 1 year

07

Study locations

1 site
  • Maasstad Hospital
    Rotterdam, Maasstadweg 21 3079 DZ, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in May 2025, 24 months.

Of 125 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's 24 months is close to that.

Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2023
First posted
Sep 21, 2023
StartActual
May 8, 2023
Primary completionActual
May 23, 2025
CompletionActual
May 23, 2025
Last update
May 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06046404
Lead sponsor
Maasstad Hospital
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
May 8, 2023
Primary completion
May 23, 2025
Completion
May 23, 2025
Last update
May 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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