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

Not Applicable

Completed

• Conditions: Distal Radius Fracture
• Interventions: Procedure: Volar plate; Device: Synthes TCP volar plate

• Registration Number: NCT02154620
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-05-02
• Study First Submitted QC: 2014-05-30
• Study First Posted: 2014-06-03
• Primary Completion: 2018-01
• Study Completion: 2018-01-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-11
• Last Update Posted: 2021-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar plate	Synthes TCP volar plate	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.
Volar plate	Volar plate	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.

Primary Outcome Measures

Name	Time	Method
Patient related wrist evaluation (PRWE)	52 weeks

Secondary Outcome Measures

Name	Time	Method
Patient related wrist evaluation (PRWE)	3 years

Trial Locations

Locations (1)

Department of Orthopaedics, Stockholm South Hospital; 🇸🇪 Stockholm, Sweden