Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Karolinska Institutet70 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

External fixationPROCEDURE

Operation with external fixation and optional addition of k-wire

Volar platePROCEDURE

Operation with a Synthes volar two column plate (TCP)

Eligibility

Sex: ALLMin age: 50 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (1)

Stockholm South Hospital Department of Orthopeadic Surgery

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

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.

Time frame: 12 months

Secondary Outcomes

A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.

Time frame: 12 months

A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.

Time frame: 12 months

Data from ClinicalTrials.gov

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