Unstable Distal Radius Fractures With Dorsal Dislocation in Patients Aged 18-64 Years. Volar Locking Plate (VLP) vs Closed Reduction and Percutaenous Pinning (CRPP).

Study Overview
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Brief Summary
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120 patients age 18-64 years with dorsally displaced distal radius fractures AO-type A2, A3 and C1 are recruited from Oslo Casualty Medical Centre (Oslo Skadelegevakt). Patients are randomized to surgery with closed reduction and pins (CRPP) or open reduction and volar locking plate (VLP). The hypotheses is that CRPP will give equal function and satisfaction to VLP. Patients are followed by current practice of follow-ups until 5 weeks postoperatively, and in addition due to the study with functional tests after 2, 3, 6 and 12 months. These follow-ups will be performed by hand therapist. Scores are also recorded from Patient-Reported Wrist and Hand Evaluation (PRWHE), Quick-Dash (Q-d) and EuroQol Questionnaire (EQ-5D) questionnaires. The main efficacy measure in the study is PRWHE scores after 12 months. There will be X-ray initially, postoperatively and after 12 months. Sub-objectives in the study are analyses of cost-effectiveness (measured by EQ 5D, personnel use, use of additional healthcare service and absence from work), and differences in complications between the two methods.

Official Title
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Unstable Distal Radius Fractures AO-type A2, A3 and C1 With Dorsal Dislocation in Patients Aged 18-64 Years. Open Reduction and Volar Locking Plate Versus Closed Reduction and Percutaenous Pinning. A Randomized Controlled Trial.

Conditions
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Wrist Fracture, Distal Radius Fractures, Colles' Fracture

Intervention / Treatment
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* Procedure: Open reduction and volar locking plate and closed reduction and K-wires.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: distal radius fractures of AO- A2, A3 and C1 which should be operated on in accordance with Norwegian guidelines >18 years and <65 years address in Oslo municipality Exclusion Criteria: multitrauma previous fracture same wrist multiple injuries on the same side not competent to consent dementia / nursing home patient substance abuse foreign / tourists median nerve compression requiring emergency surgery pathological fracture open fracture congenital malformations that make it difficult to interpret data patient does not want surgical treatment not operable due to comorbidity (ASA 4, some ASA 3 after assessment by anesthesiologist) more than 10 days after injury

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: VLP<br>Open reduction and volar locking plate | Procedure: Open reduction and volar locking plate and closed reduction and K-wires.<br>* DVR Anatomic Plate, K-wires<br>|
| Active Comparator: CRPP<br>Closed reduction and percutaenous K-wires/pins | Procedure: Open reduction and volar locking plate and closed reduction and K-wires.<br>* DVR Anatomic Plate, K-wires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Related Wrist and Hand Evaluation (PRWHE) score | PROM of 15 questions, score ranging from 0 (best) to 100 (worst) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick Dash score | PROM of 11 questions, score ranging from 0 (best) to 100 (worst) | 1 year | 
| X-ray wrist posterior-anterior and lateral view | Volar tilt (degrees), radial inclination (degrees), ulnar variance (mm), stepp-off (mm) | 1 year | 
| Range of motion | Flexion, extension, supination and pronation measured in degrees from neutral position, pulpa palm distance in cm | 1 year | 
| Grip strength | Grip strength with a hand dynamometer | 1 year |