Volar Locking Plate vs Fragment Specific Fixation in Wrist Fractures
Treatment of Distal Radial Fractures With Volar Locking Plates Versus Fragment-specific Fixation (TriMed Classic). A Randomized Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
The treatment of unstable, non-reducible distal radial fractures is still controversial. The aim of the present study is to compare the subjective, clinical and radiographic outcome of the TriMed fragment-specific system with a volar locking plate in patients with unstable, non-reducible and also redislocated distal radial fractures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 24, 2014
January 1, 2014
3 years
March 3, 2011
January 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Grip strength
Will be measured by a physiotherapist at 6 weeks, 3 months and 12 months. Evaluated at 12 months.
12 months
Secondary Outcomes (5)
Forearm rotation (pronation/supination) measured in degrees
6 weeks, 3 months and 12 months
Subjective outcome measured with QuickDASH (scale 0-100)
0, 6 weeks, 3 and 12 months
Visual Analog Scale
0, 6 weeks, 3 and 12 months
Number of reoperations
12 months
EQ-5D
0, 6 weeks, 3 and 12 months
Study Arms (2)
TriMed fragment-specific fixation
ACTIVE COMPARATORTriMed volar locking plate
ACTIVE COMPARATORInterventions
Anatomical reduction, achieved by the open technique.
Anatomical reduction, achieved by the open technique.
Eligibility Criteria
You may qualify if:
- AO type A or C fracture, unstable and non-reducible at day of trauma.
- AO type A or C fracture, redislocated at the 14 day clinical and radiological control.
- Incongruent RC-joint or DRU-joint and/or axial compression \> 2 mm and/or dorsal compression 20°.
You may not qualify if:
- Previous fracture of the same wrist
- Volar Barton fractures (AO Type B)
- Fracture on the other side or other concomitant fracture that also needs treatment.
- Open fracture
- Fracture expansion to the diaphysis
- Ongoing chemo- or radiotherapy
- Metabolic diseases that affect the bone
- Dementia, mental illness, alcohol abuse or difficulty understanding the language
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
Lund, 221 85 Lund, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Magnus Tägil, MD
Department of Hand Surgery Malmö/Lund, Lund University and Skåne University Hospital, Lund, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 9, 2011
Study Start
December 1, 2010
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 24, 2014
Record last verified: 2014-01