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| Name | Class |
|---|---|
| Stryker SA | INDUSTRY |
| Polyclinique du Parc Rambot | UNKNOWN |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| - locking anterior plate | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stéphane DESCAMPS, MD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Grip and pinch strength (5 weeks, 3, 6 and 12 months) | 5 weeks, 3, 6 and 12 months |