Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Not Applicable

Completed

• Conditions: Dorsally Displaced Intraarticular Distal Radius Fractures; Age 50 - 74 for Females or 60-74 for Males; Low Energy Trauma
• Interventions: Procedure: External fixation; Procedure: Volar plate

• Registration Number: NCT01034943
• Lead Sponsor: Karolinska Institutet

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
External fixation	External fixation	Operation with external fixation and optional addition of k-wire
Volar plate	Volar plate	Operation with Synthes volar two column plate (TCP)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stockholm South Hospital Department of Orthopeadic Surgery; 🇸🇪 Stockholm, Sweden