NCT02154620
Completed
Not Applicable
Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial
ConditionsDistal Radius Fracture
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Karolinska Institutet
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Patient related wrist evaluation (PRWE)
Overview
Brief Summary
Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.
An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.
A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
- •Low energy injury
- •Patient 70 years old or older
- •72 hours or less since injury at time of diagnosis
- •Patient registered in the Stockholm region
- •Patient understands spoken and written swedish
Exclusion Criteria
- •Intraarticular displacement in radiocarpal joint of more than 1 mm
- •Ulna fractured proximal to the base of the styloid process of ulna
- •Earlier unilateral functional impairment of hand/wrist
- •Injury to tendon, nerve or skin besides the fracture
- •Rheumatoid arthritis or other severe systemic joint disease
- •Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
- •Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
- •Medical illness that makes general anesthesia impossible
Outcomes
Primary Outcomes
Patient related wrist evaluation (PRWE)
Time Frame: 52 weeks
Secondary Outcomes
- Patient related wrist evaluation (PRWE)(3 years)
Investigators
Sari Ponzer
Professor
Karolinska Institutet
Study Sites (1)
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