Intraarticular Distal Radius Fractures, X-fix or Volar Fixation

Karolinska Institute

Status: Completed

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

Treatments: Procedure: Volar plate; Procedure: External fixation

Study type: Interventional

Funder types: Other

Identifiers

NCT01035359

DRF intra

Details and patient eligibility

About

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.

Full description

This study has been merged with NCT 01034943 and a new permit has been issued by the Swedish National board on Ethical Permits

Enrollment: 70 patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

external fixation

Active Comparator group

Description:

Operation with external fixation and optional addition of k-wire

Treatment:

Procedure: External fixation

Volar plate

Experimental group

Description:

Operation with a Synthes volar two column plate (TCP)

Treatment:

Procedure: Volar plate