Metaphyseal Radius Fractures (AO Type A2, A3, C1 et C2)
Conditions
Keywords
Fracture, Radius, Osteosynthesis, Metaphyseal, Pinning, Locking anterior plate
Brief summary
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
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.
Interventions
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.
Sponsors
Stryker SA
Polyclinique du Parc Rambot
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
France
Outcome results
None listed