Wrist FracturesRECORDEDNCT06046404
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
A study testing closed reduction and no closed reduction in people with Wrist Fractures and Distal Radius Fractures, run by Maasstad Hospital at 1 site in Netherlands.
Trial summary
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast
- What is being tested?
- closed reduction and no closed reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 May 2023to 23 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- displaced distal radial fracture eligible for surgery
Who cannot join
- ISS traumascore >16
- open fracture
- multiple fractures in ipsilateral extremety
- neurovascular damage
- previous injury in the same wrist
- inability to complete questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast, Wrist Injuries, Radius Fracture Distal
- Being tested
- closed reduction, no closed reduction
- Medical subject headings
- Wrist Fractures, Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed reductionProcedure or surgery
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.
no closed reductionProcedure or surgery
no reduction will be performed
| Study group | Role | What they receive |
|---|---|---|
| closed reduction followed by plaster casting | Active comparator | Not described Receives: Procedure: closed reduction |
| only plaster casting | Experimental | no closed reduction will be performed Receives: Procedure: no closed reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: usually 2-10 days
Secondary outcomes (5)
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.
Measured: 6 weeks, 3, 6 and 12 months
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.
Measured: 1 year
Wrist mobility
Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.
Measured: 6 weeks and 3 months
length of stay in emergency department
length of stay in emergency department
Measured: baseline
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start8 May 2023
- Primary completion23 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maasstad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046404
- Sponsor's protocol ID
- L2022093
- Acronym
- RECORDED
- Status last verified
- May 2026
- First submitted
- 8 Sep 2023
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
- ClinicalTrials.gov ID
- NCT06046404
- Acronym / sponsor ID
- RECORDED / L2022093
- Conditions
- Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast, Wrist Injuries, Radius Fracture Distal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Maasstad HospitalUniversity, hospital or other
- Study start
- 8 May 2023 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed reduction followed by plaster casting | Active comparator | Procedure: closed reduction |
| only plaster casting | Experimental | Procedure: no closed reductionno closed reduction will be performed |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- displaced distal radial fracture eligible for surgery
Key exclusion criteria (6 listed)
- ISS traumascore >16
- open fracture
- multiple fractures in ipsilateral extremety
- neurovascular damage
- previous injury in the same wrist
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed reductionthe 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. | Procedure or surgery | closed reduction followed by plaster casting |
| no closed reductionno reduction will be performed | Procedure or surgery | only plaster casting |
Primary outcome
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.
5 secondary outcomes
function
Time frame: 6 weeks, 3, 6 and 12 months
Number of complications
Time frame: 1 year
Wrist mobility
Time frame: 6 weeks and 3 months
length of stay in emergency department
Time frame: baseline
quality of life in EQ5D5L
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed reduction and no closed reduction in people with Wrist Fractures and Distal Radius Fractures, run by Maasstad Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
daily pain scores (time frame: usually 2-10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.