Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Hip Fracture Clinical Trial

— TRAUMAX  

Official title:

Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703716
• Other study ID #: RECON-EMEA-06
• Status: Completed
• Phase: N/A
• First received: June 20, 2008
• Last updated: September 10, 2014
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: September 2014
• Source: Integra LifeSciences Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture
• Hip Fractures

Locations

Country	Name	City	State
France	Hôpital d'Instruction des Armées R. Picqué	Bordeaux
France	CHU La Cavale Blanche	Brest
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	Clinique de l'alliance	Saint Cyr sur loire
France	Nouvelle Clinique de l'Union et du Vaurais	Saint Jean
France	CHU Toulouse	Toulouse
France	Centre Hospitalier Saint Cyr	Villeneuve sur lot

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Services

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The consolidation rate		6 months after surgery	No
Primary	The rate of complication due to the device		6 months after surgery	Yes
Secondary	The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.		3 and 6 months after surgery	No
Secondary	PMA score		3 and 6 months after surgery	No
Secondary	operating time		during the surgery	No
Secondary	The duration of the use of the amplifier of brilliancy during the intervention		during the surgery	No
Secondary	The radiological position of the device		5 days, 3 and 6 months	No