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

Primary Purpose

Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
closed reduction
no closed reduction
Sponsored by
Maasstad Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrist Fractures

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maasstad HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

closed reduction followed by plaster casting

only plaster casting

Arm Description

no closed reduction will be performed

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Wrist mobility
Range of motion will be reported in form of wrist flexion and extension and pro- and supination, in degrees.
length of stay in emergency department
length of stay in emergency department
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.

Full Information

First Posted
September 8, 2023
Last Updated
September 18, 2023
Sponsor
Maasstad Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06046404
Brief Title
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Acronym
RECORDED
Official Title
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maasstad Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Fractures, Distal Radius Fractures, Closed Reduction of Fracture and Application of Plaster Cast, Wrist Injuries, Radius Fracture Distal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
cluster randomization
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
closed reduction followed by plaster casting
Arm Type
Active Comparator
Arm Title
only plaster casting
Arm Type
Experimental
Arm Description
no closed reduction will be performed
Intervention Type
Procedure
Intervention Name(s)
closed reduction
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
no closed reduction
Intervention Description
no reduction will be performed
Primary Outcome Measure Information:
Title
daily pain scores
Description
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 Outcome Measure Information:
Title
function
Description
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
Title
Number of complications
Description
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
Title
Wrist mobility
Description
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
Title
length of stay in emergency department
Description
length of stay in emergency department
Time Frame
baseline
Title
quality of life in EQ5D5L
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bas M Derksen, MsC
Phone
0031618027390
Email
DerksenB@maasstadziekenhuis.nl
Facility Information:
Facility Name
Maasstad Hospital
City
Rotterdam
State/Province
Maasstadweg 21
ZIP/Postal Code
3079 DZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bas M Derksen, MsC
Phone
+31618027390
Email
DerksenB@maasstadziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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