Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Integra LifeSciences

Status: Completed

Conditions: Hip Fracture

Study type: Observational

Funder types: Industry

Identifiers

NCT00703716

RECON-EMEA-06

Details and patient eligibility

About

The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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