Conservative Treatment vs. Volar Plating of Distal Radius Fractures

Not Applicable

Completed

• Conditions: Distal Radius Fractures
• Interventions: Procedure: Volar plating; Procedure: Conservative treatment

• Registration Number: NCT02990052
• Lead Sponsor: University of Oulu

Brief Summary

A prospective, randomized controlled single-center trial with 80 patients aged 50 years and above to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture

Detailed Description

Volar plating has became as a standard approach for treating unstable distal radius fractures. The incidence of surgically treated patients with distal radius fractures has increased many fold from the beginning of this millennium, owing mostly to increased number of volar platings. The most striking increase of plate fixations has occurred in older patient groups, especially in females. With volar fixed-angle plate, very near-anatomic, stable fixation with relatively low complication rate, can be achieved even in osteoporotic bone. There are only few randomized, prospective studies comparing results of volar plating and conservative treatment, comparing patients aged over 65 years. Quite little is known of the results comparing conservative treatment and volar plating in patients aged below 65 years.

Main goal of our study was to compare the functional and radiological results of conservative treatment and volar fixed-angle plating in the management of distal radius fracture in patients aged over 50 years an older.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2014-01
• Study Completion: 2016-01
• Study First Submitted: 2016-11-07
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-09
• Last Update Submitted: 2016-12-09
• Study First Posted: 2016-12-12
• Last Update Posted: 2016-12-12

Recruitment & Eligibility

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

Inclusion Criteria

• patients over 50 years-old
• primary dislocated distal radius fracture (AO/OTA 23 type A2-3 and C1-2)
• primary reduction of fracture is acceptable considering primary conservative treatment

Exclusion Criteria

• bilateral and open fractures and fractures with neurovascular compromise
• other major concurrent fracture necessitating treatment of any kind
• patients under 50 years of age
• previous ipsilateral distal radius fracture
• inflammatory joint disease
• significant radiocarpal-joint degeneration
• patient's bad co-operation or major co-morbidity making an operation contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volar plating	Volar plating	Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
Conservative treatment	Conservative treatment	Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.

Primary Outcome Measures

Name	Time	Method
Difference of DASH-score between two study groups	2 year observation	Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity

Secondary Outcome Measures

Name	Time	Method
Difference of radiological parameters between two study groups	2 year observation	Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint