Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

Study Overview
=================
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 NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

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

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

Intervention / Treatment
-----------------
* Procedure: External fixation
* Procedure: Volar plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 50-74 years or male 60-74 years Dorsally displaced intraarticular 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 major risk

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: external fixation<br>Operation with external fixation and optional addition of k-wire | Procedure: External fixation<br>* Bridging external fixation of a distal radius fracture with an optional addition of k-wire(s)<br>* Other names: Stryker's Hoffman external fixation;|
| Experimental: Volar plate<br>Operation with a Synthes volar two column plate (TCP) | Procedure: Volar plate<br>* Operation of distal radius fracture with open reduction and fixation with a plate from the volar side of the wrist.<br>* Other names: Synthes Two Column Plate (TCP);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A secondary outcome is the degree of malalignment on the x-ray of the injured wrist. |  | 12 months | 
| A secondary outcome of this study is the EQ5D, which is a validated quality-of-life instrument. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radius, fracture, wrist, external, fixation, volar, plate, DASH, PRWE