Volar Locked Plating vs Bridging External Fixation in Distal Radius Fracture

Study Overview
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Brief Summary
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The purpose of this study is to evaluate function, pain and radiographic evaluation in patients treated with volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular distal radius fractures, AO/OTA type A

Detailed Description
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We have designed a randomized prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation in patients with extraarticular dislocated distal radius fractures AO/OTA type A3. On the basis of power analysis a total of 160 patients are to be included in this project. The follow-up period is 1 year and evaluation is based on x-ray analysis, grip strength, range of motion, pain and satisfaction with the treatment ( PRWE, Quick-DASH)

Official Title
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A Randomized, Prospective Comparison of Volar Locked Plating Versus Hoffman II Bridging External Fixation in Patients With Dislocated Distal Radius Fractures, AO/OTA Type A.

Conditions
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Distal Radius Fracture

Intervention / Treatment
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* Device: Volar locked plating
* Device: Hoffman external fixator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with dislocated extraarticular distal radius fracture age 18-70 years Exclusion Criteria: Cognitively impaired Drug abuse Congenital bone disease Earlier wrist injury Open fracture, Gustilo-Anderson type 3 Pathological fractures( except osteoporotic fractures) Tourists

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 locked plating<br>One group with distal radius fracture is operated with Locking plate | Device: Volar locked plating<br>* Operative treatment of distal radius fracture with volar locking plate<br>* Other names: DVR Anatomic plate, Hand Innovations, De Puy;|
| Active Comparator: Hoffman external fixator<br>One group with distal radius fracture is operated with Hoffman external fixator | Device: Hoffman external fixator<br>* Patients with distal radius fracture operated with Hoffman external fixator<br>* Other names: Bridging Hoffman II Compact, Stryker;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient rated wrist evaluation (PRWE)score |  | 3 months | 
| Patient rated wrist evaluation (PRWE)score |  | 6 weeks | 
| Patient rated wrist evaluation (PRWE)score |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick-DASH score |  | 6 weeks, 3 and 12 months | 
| Pain VAS-score |  | 6 weeks, 3 and 12 months | 
| Complications | Number of patients with per- and postoperative complications will be registrated. Types of expected complications: Tendon rupture, Tendon irritation, Carpal Tunnel Syndrome, Complex Regional Pain Syndrome, Screw displacement/screw loosening, Delayed fracture union | 6 weeks, 3 and 12 months | 
| Radiographic evaluation | Palmar tilt, Radial inclination, Ulnar variance, Fracture union | 6 weeks and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal radius fracture