Metaphyseal Distal Radius Fractures

Study Overview
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Brief Summary
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The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.

Detailed Description
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Because an increasing number of elderly patient, the number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques exist of which in particular locking plates and intrafocal pinning. The availability of new materials (locking plates with angular stability) seems to reduce the risks of osteosynthesis failure and seems to give more constant results: hawever, the price to pay is a more invasive technique and a superior cost. The rehabilitation seems also faster, allowing the possibility to get back the maximum of autonomy. These clinical facts need of course to be validated.

Official Title
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Locking Plate Versus Pins for Surgical Treatment of Posteriorly Tilted Distal Radius Fracture

Conditions
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Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)

Intervention / Treatment
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* Device: - locking anterior plate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - metaphyseal inferior radius fractures (AO classification 23A2, 23A3, 23C1, 23C2) age 60 years or older Exclusion Criteria: open fracture fractures AO classification: 23A1, 23C3, 23B1, 23B2, 23B3 polytraumatized patient fractures older than 15 days infection of the operating site previous osseous disease

Ages Eligible for Study
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Minimum Age: 60 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

| Intervention/Treatment |
| --- |
|Device: - locking anterior plate|The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques. The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - X-ray assessments (preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths) |  | preoperative, postoperative; 2 weeks, 5 weeks, 3, 6 and 12 mouths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PAIN score (2 weeks, 5 weeks, 3, 6 and 12 months) |  | 2 weeks, 5 weeks, 3, 6 and 12 months | 
| Gartland, O'Brien, DASH and Euroquol EQ-5D scores (5 weeks, 3, 6 and 12 months) |  | 5 weeks, 3, 6 and 12 months | 
| Grip and pinch strength (5 weeks, 3, 6 and 12 months) |  | 5 weeks, 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate