Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Completed

• Conditions: Hip Fracture

• Registration Number: NCT00703716
• Lead Sponsor: Integra LifeSciences Services

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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-20
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-10
• Last Update Posted: 2014-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The consolidation rate	6 months after surgery
The rate of complication due to the device	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

CHU La Cavale Blanche; 🇫🇷 Brest, France

Hôpital d'Instruction des Armées R. Picqué; 🇫🇷 Bordeaux, France

Centre Hospitalier Départemental de Vendée; 🇫🇷 La Roche sur Yon, France

Centre Hospitalier du Nord Mayenne; 🇫🇷 Mayenne, France

CHU Nantes; 🇫🇷 Nantes, France

Hopital Saint Antoine; 🇫🇷 Paris, France

Nouvelle Clinique de l'Union et du Vaurais; 🇫🇷 Saint Jean, France

Clinique de l'alliance; 🇫🇷 Saint Cyr sur loire, France

Centre Hospitalier Saint Cyr; 🇫🇷 Villeneuve sur lot, France

CHU Toulouse; 🇫🇷 Toulouse, France