Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Dorsally Displaced Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster - A Prospective Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02154620

Acronym

Enrollment

130

Registered

2014-06-03

Start date

2013-04-30

Completion date

2018-01-31

Last updated

2021-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Radius Fracture

Keywords

Distal radius fracture, wrist fracture, volar plate, surgical treatment, plaster immobilisation

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.

Interventions

PROCEDUREVolar plate

An anatomically countoured volar plate is implanted through a Henry's incision.

DEVICESynthes TCP volar plate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Patient related wrist evaluation (PRWE)	52 weeks

Secondary

Measure	Time frame
Patient related wrist evaluation (PRWE)	3 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026