Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Dorsally Displaced Extraarticular Distal Radius Fractures - Volar Plate or External Fixation. A Prospective Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01034943

Enrollment

Registered

2009-12-18

Start date

2009-08-31

Completion date

2014-02-28

Last updated

2014-03-13

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

Conditions

Dorsally Displaced Intraarticular Distal Radius Fractures, Age 50 - 74 for Females or 60-74 for Males, Low Energy Trauma

Keywords

radius, fracture, wrist, external, fixation, volar, plate, DASH, PRWE

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.

Detailed description

This study has been merged with study NCT01035359 and a new ethical permission has been granted by the Swedish National Ethic board

Interventions

PROCEDUREExternal fixation

Operation with external fixation and optional addition of k-wire

PROCEDUREVolar plate

Operation with a Synthes volar two column plate (TCP)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 74 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026