Distal Radius Fractures Clinical Trial
— RECORDEDOfficial title:
Refraining From Closed Reduction of Dislocated Distal Radius Fractures in the Emergency Department
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 |
The investigators test the efficacy of closed reduction in displaced distal radial fractures in the emergency department.
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maasstad Hospital | Rotterdam | Maasstadweg 21 |
Lead Sponsor | Collaborator |
---|---|
Maasstad Hospital |
Netherlands,
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 |
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