Extraarticular Distal Radius Fractures, X-fix or Volar Fixation

Age 50 - 74 for Females or 60-74 for Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034943
• Other study ID #: DRF Extra
• Status: Completed
• Phase: N/A
• First received: December 16, 2009
• Last updated: March 12, 2014
• Start date: August 2009
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Swedish National Council on Medical Ethics, Sweden:
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 74 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• External fixation
Operation with external fixation and optional addition of k-wire
• Volar plate
Operation with a Synthes volar two column plate (TCP)

Locations

Country	Name	City	State
Sweden	Stockholm South Hospital Department of Orthopeadic Surgery	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	A secondary outcome measure is the degree of malalignment on the x-ray of the injured wrist.		12 months	No
Secondary	A secondary outcome measure for this study is the EQ5D, a validated quality-of-life instrument.		12 months	No