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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00703716
Recruitment Status : Completed
First Posted : June 23, 2008
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
Integra LifeSciences Services

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

Condition or disease
Hip Fracture

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
Actual Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
Study Start Date : May 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The consolidation rate [ Time Frame: 6 months after surgery ]
  2. The rate of complication due to the device [ Time Frame: 6 months after surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. PMA score [ Time Frame: 3 and 6 months after surgery ]
  3. operating time [ Time Frame: during the surgery ]
  4. The duration of the use of the amplifier of brilliancy during the intervention [ Time Frame: during the surgery ]
  5. The radiological position of the device [ Time Frame: 5 days, 3 and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00703716

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, France
Sponsors and Collaborators
Integra LifeSciences Services
Principal Investigator: CHIRON Philippe CHU Rangueil, Toulouse, FRANCE

Responsible Party: Integra LifeSciences Services Identifier: NCT00703716     History of Changes
Other Study ID Numbers: RECON-EMEA-06
First Posted: June 23, 2008    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: September 2014

Keywords provided by Integra LifeSciences Services:
dynamic screw-plate

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries