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Completed

NCT Number: NCT06046404

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

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

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Key information

Conditions

Wrist Fractures Arm Injuries Closed Reduction of Fracture and Application of Plaster Cast Distal Radius Fractures Fractures, Bone Radius Fracture Distal Wounds and Injuries Wrist Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maasstad Hospital

Rotterdam, Maasstadweg 21, 3079 DZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed reduction

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.

no closed reduction

Procedure

no reduction will be performed

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. length of stay in emergency department

    Time frame: baseline

    length of stay in emergency department

  5. 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.

Sponsors and collaborators

Lead sponsor

Maasstad Hospital

Other

Registry information

Acronym: RECORDED

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 21, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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