Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hip Fracture
- Sponsor
- Integra LifeSciences Services
- Enrollment
- 190
- Locations
- 10
- Primary Endpoint
- The consolidation rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX
Detailed Description
Hip fractures are a serious public health problem. The current incidence is projected to increase fourfold worldwide by the year 2050. This affliction is obviously linked to the aging of the population and the absence of a systematic prevention of osteoporosis. This leads to the creation of a minimally invasive, or ever percutaneous, implantable osteosynthesis material which associates : * the well-known reliability of osteosynthesis using screw-plate with barrel, * the safety of the fixation with Surfix concept, locking the screws to the plate using lock-screws, * a modularity thanks to the choice between 3 sizes of barrel, * the creation of a simple material, easing the operative surgery by minimally invasive approach. The TRAUMAX answers to all those characteristics.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Man or woman
- •Age \> 18
- •with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
Exclusion Criteria
- •Patient with an acute infection
- •Patient with a major osseous deterioration which not allows a correct support of the screws in the bone
- •Patient with an ASA score of 4 or 5
- •Patient whom the time between the fracture and the surgery could be higher than 8 days
Outcomes
Primary Outcomes
The consolidation rate
Time Frame: 6 months after surgery
The rate of complication due to the device
Time Frame: 6 months after surgery
Secondary Outcomes
- operating time(during the surgery)
- PMA score(3 and 6 months after surgery)
- The duration of the use of the amplifier of brilliancy during the intervention(during the surgery)
- The radiological position of the device(5 days, 3 and 6 months)
- The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.(3 and 6 months after surgery)