Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly

Wrist Fracture Clinical Trial

— VOCAL  

Official title:

Unstable Dorsally Displaced Fractures of the Distal Radius in the Elderly. A Randomized Comparison Between Operative Fixation and Plaster Cast Treatment.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01268397
• Other study ID #: Wilcke-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2009
• Est. completion date: December 2019

Study information

• Verified date: April 2018
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Fracture of the Distal Radius
• Fractures, Bone
• Wrist Fracture

Intervention

Procedure:
• open reduction and internal fixation with a volar plate
flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
• closed reduction and plaster treatment
closed reduction, below elbow plaster cast, semicircular for 5 week

Locations

Country	Name	City	State
Sweden	Division of Orthopaedics Danderyd Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient-perceived disability measured by the PRWE and DASH questionnaires		one year after wrist fracture
Secondary	impairments (grip strength and range of motion compared with the uninjured wrist)		one year after wrist fracture