Conservative Treatment vs. Volar Plating of Distal Radius Fractures (DRF)
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|ClinicalTrials.gov Identifier: NCT02990052|
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Distal Radius Fractures||Procedure: Volar plating Procedure: Conservative treatment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Conservative Treatment vs. Volar Plating of Distal Radius Fractures in Patients Aged Over 50 Years Old: A Prospective Randomized Trial|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2016|
Active Comparator: Volar plating
Volar fixed-angle plating for dislocated distal radius fracture after closed reduction.
Procedure: Volar plating
Open reduction and volar fixed-angle plate fixation of distal radius fracture
Active Comparator: Conservative treatment
Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture.
Procedure: Conservative treatment
Closed reduction & casting of distal radius fracture
- Difference of DASH-score between two study groups [ Time Frame: 2 year observation ]Disability of the Arm, Shoulder and Hand -Score assessing the function of the upper extremity
- Difference of radiological parameters between two study groups [ Time Frame: 2 year observation ]Dorsal angulation, ulnar variance and radial inclination of distal radius. Osteoarthritis of radiocarpal joint