Clinical trial NCT00703716: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
Official title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Keywords: mini-invasive
dynamic screw-plate
Surfix
Lock-screw
Lead sponsor: Integra LifeSciences Services
Sponsor class: INDUSTRY
First posted: 2008-06-23
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX

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.

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

Primary outcomes:
measure: The consolidation rate
timeFrame: 6 months after surgery
measure: The rate of complication due to the device
timeFrame: 6 months after surgery
Secondary outcomes:
measure: The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.
timeFrame: 3 and 6 months after surgery
measure: PMA score
timeFrame: 3 and 6 months after surgery
measure: operating time
timeFrame: during the surgery
measure: The duration of the use of the amplifier of brilliancy during the intervention
timeFrame: during the surgery
measure: The radiological position of the device
timeFrame: 5 days, 3 and 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hôpital d'Instruction des Armées R. Picqué
city: Brest
country: France
facility: CHU La Cavale Blanche
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental de Vendée
city: Mayenne
country: France
facility: Centre Hospitalier du Nord Mayenne
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Saint Antoine
city: Saint Cyr sur loire
country: France
facility: Clinique de l'alliance
city: Saint Jean
country: France
facility: Nouvelle Clinique de l'Union et du Vaurais
city: Toulouse
country: France
facility: CHU Toulouse
city: Villeneuve sur lot
country: France
facility: Centre Hospitalier Saint Cyr
Study officials:
affiliation: CHU Rangueil, Toulouse, FRANCE
name: CHIRON Philippe
role: PRINCIPAL_INVESTIGATOR
References: