Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX (TRAUMAX)

September 10, 2014 updated by: Integra LifeSciences Services
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Hôpital d'Instruction des Armées R. Picqué
      • Brest, France
        • CHU La Cavale Blanche
      • La Roche sur Yon, France
        • Centre Hospitalier Departemental de Vendee
      • Mayenne, France
        • Centre Hospitalier du Nord Mayenne
      • Nantes, France
        • CHU Nantes
      • Paris, France
        • Hopital Saint Antoine
      • Saint Cyr sur loire, France
        • Clinique de l'Alliance
      • Saint Jean, France
        • Nouvelle Clinique de l'Union et du Vaurais
      • Toulouse, France
        • CHU Toulouse
      • Villeneuve sur lot, France
        • Centre Hospitalier Saint Cyr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The consolidation rate
Time Frame: 6 months after surgery
6 months after surgery
The rate of complication due to the device
Time Frame: 6 months after surgery
6 months after surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Services

Investigators

  • Principal Investigator: CHIRON Philippe, CHU Rangueil, Toulouse, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

June 20, 2008

First Submitted That Met QC Criteria

June 20, 2008

First Posted (ESTIMATE)

June 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 11, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECON-EMEA-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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