Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00703716

Acronym

TRAUMAX

Enrollment

190

Registered

2008-06-23

Start date

2008-05-31

Completion date

2010-12-31

Last updated

2014-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture

Keywords

mini-invasive, dynamic screw-plate, Surfix, Lock-screw

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The consolidation rate	6 months after surgery
The rate of complication due to the device	6 months after surgery

Secondary

Measure	Time frame
operating time	during the surgery
The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.	3 and 6 months after surgery
The radiological position of the device	5 days, 3 and 6 months
The duration of the use of the amplifier of brilliancy during the intervention	during the surgery
PMA score	3 and 6 months after surgery

Countries

France

Outcome results