Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

Not Applicable

• Conditions: Fracture of the Distal Radius; Wrist Fracture
• Interventions: Procedure: open reduction and internal fixation with a volar plate; Procedure: closed reduction and plaster treatment

• Registration Number: NCT01268397
• Lead Sponsor: Danderyd Hospital

Brief Summary

The purpose of this study is to examine whether operation and fixation with a metal plate gives better result from the patient's perspective than plaster treatment in elderly patients with a displaced wrist fracture.

Detailed Description

We will perform a prospective randomized clinical trial comparing open reduction and internal fixation with a volar plate with closed reduction and plaster treatment in elderly patients with a displaced Colles' fracture in order to test the null hypothesis that the patient-perceived result is equal after conservative or operative treatment. Secondary outcomes are objective physical measurements.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-12-29
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-30
• Primary Completion: 2018-01
• Status Verified: 2018-04
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-08
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Unilateral unstable dislocated dorsally angulated fracture of the distal radius (radial shortening ≥4 mm and/or dorsal angulation ≥20°).

Exclusion Criteria

• Previous displaced fracture of the distal radius.
• Additional fractures of the upper extremities, an open fracture, terminal disease, patient not fit for surgery, unwilling or unable to co-operate with follow-up (advanced dementia (SPMSQ<5), psychiatric illness, alcohol abuse).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORIF	open reduction and internal fixation with a volar plate	Open reduction and internal fixation with a volar plate
plaster treatment	closed reduction and plaster treatment	Closed reduction and plaster treatment

Primary Outcome Measures

Name	Time	Method
patient-perceived disability measured by the PRWE and DASH questionnaires	one year after wrist fracture

Secondary Outcome Measures

Name	Time	Method
impairments (grip strength and range of motion compared with the uninjured wrist)	one year after wrist fracture

Trial Locations

Locations (1)

Division of Orthopaedics Danderyd Hospital; 🇸🇪 Stockholm, Sweden