Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06046404
Other study ID # L2022093
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 8, 2023
Est. completion date July 2025

Study information

Verified date September 2023
Source Maasstad Hospital
Contact Bas M Derksen, MsC
Phone 0031618027390
Email DerksenB@maasstadziekenhuis.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 134
Est. completion date July 2025
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Intervention

Procedure:
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.
no closed reduction
no reduction will be performed

Locations

Country Name City State
Netherlands Maasstad Hospital Rotterdam Maasstadweg 21

Sponsors (1)

Lead Sponsor Collaborator
Maasstad Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 6 weeks, 3, 6 and 12 months
Secondary 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. 1 year
Secondary Wrist mobility Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees. 6 weeks and 3 months
Secondary length of stay in emergency department length of stay in emergency department baseline
Secondary 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. 1 year
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06453447 - Prednisone for CRPS in Distal Radius Fracture N/A
Recruiting NCT06136286 - ORIF Distal Radius Blood Flow Restriction Therapy N/A
Not yet recruiting NCT06078371 - Opioid-Free Pain Treatment in Trauma Patients N/A
Not yet recruiting NCT05902442 - A Clinical Comparison of Patient-specific 3D Printed Splints Versus Conventional Splints in the Treatment of Distal Radius Fractures. N/A
Completed NCT02990052 - Conservative Treatment vs. Volar Plating of Distal Radius Fractures N/A
Withdrawn NCT00788190 - Treatment of Distal Radius Fractures in Elderly Patients N/A
Completed NCT06343467 - Do Generic Volar Locking Plates Provide Similar Outcomes at a Reduced Cost? N/A
Not yet recruiting NCT06251206 - Impact of Early ADL Education on Outcomes Post DRF ORIF Phase 1
Completed NCT00654615 - Fixation of Unstable Distal Radius Fractures N/A
Completed NCT01937624 - Pediatric Distal Radius US Study
Completed NCT01007565 - Postoperative Pain After Volar Plating for Distal Radius Fractures Phase 2
Terminated NCT01859468 - A Study Comparing the Effect of Amorphous Calcium Carbonate (ACC) on Healing Time of Distal Radius Fractures Phase 1/Phase 2
Completed NCT01103297 - 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Phase 4
Completed NCT05942950 - Predicting Outcomes of Distal Radius Fractures: a Surgeon Survey
Completed NCT06215872 - Effectiveness of Structured Myofacial Chain Exercises After Distal Radius Fracture N/A
Suspended NCT01693094 - A Randomized Trial Measuring the Effect of Decision Aids on Patients' Satisfaction, Conflict of Decision-making and Clinical Outcome N/A
Not yet recruiting NCT06235957 - Three Weeks of Cast Immobilisation Versus One Week of Brace Immobilisation in Distal Radius Fractures N/A
Recruiting NCT06019585 - Inmobilization With Compression Bandage vs Antebraquial Splint in Distal Radius Fractures N/A
Terminated NCT02802774 - Immobilization of Postoperative Distal Radius Fractures N/A
Enrolling by invitation NCT05086224 - Hematoma Block Versus Bier Block for Closed Fracture Reduction Early Phase 1