Status:
UNKNOWN
Volar Locking Plate Versus External Fixation for Distal Radius Fracture - a Longterm Follow up
Lead Sponsor:
Olof Skoldenberg
Collaborating Sponsors:
The Swedish Association for Survivors of Accident and Injury
Conditions:
Radius Fracture Distal
Surgery
Eligibility:
All Genders
20-74 years
Phase:
NA
Brief Summary
A 10-year follow up of a fusion of two earlier published randomized controlled trials. 203 patients with displaced distal radius fractures were randomized to surgery with a volar locking plate or exte...
Detailed Description
Follow up includes PROMs (DASH, PRWE, EQ-5D), radiological assesment and objective tests by a hand occupational therapist (ROM, grip strength). Previous Clinical trials registration for the original ...
Eligibility Criteria
Inclusion
- DS center
- acute unilateral dorsally displaced distal radius fracture with a axial shortening of at least 4 mm or a dorsal displacement of at least 20 degrees.
- Age 20-70
- SÖS center
- Age 50-74 for women and 60-74 for men
- injury only after fall from a standing height
- wrist radiography of at least 20 degrees dorsal dislocation and/or at least 5 mm axial shortening
- good knowledge of written and spoken swedish
- fracture diagnosed within 72 hours from injury
- patient resident within the catchment area of SÖS center
Exclusion
- DS center:
- no previous fracture of either wrist
- ipsilateral acute fracture of the upper extremity
- medicated with warfarin
- unable to cooperate with follow-up (dementia, substance abuse, psychiatric illness, language problems)
- open fracture
- fracture that was not amenable by both methods (distal fragment to small or to comminuted)
- SÖS center:
- former disability of either wrist
- other concomitant injuries
- rheumatoid arthritis or other severe joint disorder
- Dementia or pfeiffer score under 5 points
- drug abuse, alcohol abuse or psychiatric disorder
- dependency in activity of daily living
- medical condition contradicting general anesthesia
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2023
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT05371938
Start Date
April 1 2022
End Date
October 1 2023
Last Update
May 12 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital, Division of Ortopeadics
Stockholm, Sweden, 182 88