Distal Radius Fractures in Patients Over 70 Years - Volar Plate or Plaster

Karolinska Institute

Status: Completed

Conditions: Distal Radius Fracture

Treatments: Device: Synthes TCP volar plate; Procedure: Volar plate

Study type: Interventional

Funder types: Other

Identifiers

NCT02154620

70

Details and patient eligibility

About

Distal radius fractures with dorsal dislocation among patients 70 years or older are randomized to conservative treatment with plaster or internal fixation with a volar plate. Thereafter they are followed at 2 weeks, 5 weeks, 3 months and 12 months with x-ray, functional scores and clinical examination.

An additional follow up at three years with X-ray, functional scores and clinical outcome will be conducted after a new written consent of continued participation in the study.

A health economy analysis will be preformed at 1, and 3 years for the participants with complete EQ5D.

Enrollment: 130 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Dorsally displaced, 20 degrees or from a plane perpendicular do the diaphyseal axis, fracture.
• Low energy injury
• Patient 70 years old or older
• 72 hours or less since injury at time of diagnosis
• Patient registered in the Stockholm region
• Patient understands spoken and written swedish

Exclusion criteria

• Intraarticular displacement in radiocarpal joint of more than 1 mm
• Ulna fractured proximal to the base of the styloid process of ulna
• Earlier unilateral functional impairment of hand/wrist
• Injury to tendon, nerve or skin besides the fracture
• Rheumatoid arthritis or other severe systemic joint disease
• Severe psychiatric disorder, ongoing drug abuse or dementia (Pfeiffer score 5 points or less)
• Besides the wrist fracture also other big injuries, for example fracture of hip, shoulder or ankle
• Medical illness that makes general anesthesia impossible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Plaster cast

No Intervention group

Description:

The patient will be treated in a dorsal plaster cast for 4 weeks following the injury to the wrist

Volar plate

Experimental group

Description:

The patient will undergo surgery to the injured wrist with a Synthes Two-column plate (TCP) with a volar approach. Cast will be worn 2 weeks after surgery.

Treatment:

Procedure: Volar plate

Device: Synthes TCP volar plate