Conservative Treatment vs. Volar Plating of Distal Radius Fractures

Distal Radius Fractures Clinical Trial

— DRF  

Official title:

Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02990052
• Other study ID #: Distal Radius Fr. Sirniö
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: December 9, 2016
• Start date: November 2008
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Valvira - National Supervisory Authority for Welfare and Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Radius Fractures

Intervention

Procedure:
• Volar plating
Open reduction and volar fixed-angle plate fixation of distal radius fracture
• Conservative treatment
Closed reduction & casting of distal radius fracture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of DASH-score between two study groups	Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity	2 year observation	No
Secondary	Difference of radiological parameters between two study groups	Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint	2 year observation	No