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Completed

NCT Number: NCT00703716

Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Services

Industry

Registry information

Acronym: TRAUMAX

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2008
Registry last updated
Sep 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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