Conservative Treatment vs. Volar Plating of Distal Radius Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Distal Radius Fractures

Intervention / Treatment
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* Procedure: Volar plating
* Procedure: Conservative treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Volar plating<br>Volar fixed-angle plating for dislocated distal radius fracture after closed reduction. | Procedure: Volar plating<br>* Open reduction and volar fixed-angle plate fixation of distal radius fracture<br>|
| Active Comparator: Conservative treatment<br>Primary conservative treatment (closed reduction and casting) for dislocated distal radius fracture. | Procedure: Conservative treatment<br>* Closed reduction & casting of distal radius fracture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |