Extraarticular Distal Radius Fractures, X-fix or Volar Fixation
Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial
1 other identifier
interventional
70
1 country
1
Brief Summary
Distal radius fractures are treated surgically if severely displaced. This study aims to investigate the outcome after surgery. The investigators will randomize patients to either external fixation with optional addition of k-wires or open reduction and fixation with a volar plate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2009
Longer than P75 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
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 16, 2009
CompletedFirst Posted
Study publicly available on registry
December 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMarch 13, 2014
March 1, 2014
3.5 years
December 16, 2009
March 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome is measured by DASH (Disability of the Arm, Shoulder and Hand), which is a self administered questionnaire validated for disease and dysfunction of the upper limb.
12 months
Secondary Outcomes (2)
A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.
12 months
A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.
12 months
Study Arms (2)
External fixation
ACTIVE COMPARATOROperation with external fixation and optional addition of k-wire
Volar plate
ACTIVE COMPARATOROperation with Synthes volar two column plate (TCP)
Interventions
Operation with external fixation and optional addition of k-wire
Operation with a Synthes volar two column plate (TCP)
Eligibility Criteria
You may qualify if:
- Female 50-74 years or male 60-74 years
- Dorsally displaced extraarticular distal radius fracture
- Dorsal angulation \>20 degrees measured from the plane perpendicular to the radius axis
- Low energy trauma
- Injury \<72 hours when diagnosed
- Patient independent of help for ADL
You may not qualify if:
- Earlier dysfunction in any wrist
- Other major injuries
- Rheumatoid arthritis or other systemic joint disease
- Dementia or severe psychiatric disease
- Severe medical condition making general anesthesia a considerable risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stockholm South Hospital Department of Orthopeadic Surgery
Stockholm, Stockholm County, 118 83, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sari Ponzer, Professor
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, Consultant orthopeadic surgeon
Study Record Dates
First Submitted
December 16, 2009
First Posted
December 18, 2009
Study Start
August 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2014
Last Updated
March 13, 2014
Record last verified: 2014-03