Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Services
ClinicalTrials.gov Identifier:
NCT00703716
First received: June 20, 2008
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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


Condition
Hip Fracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Services:

Primary Outcome Measures:
  • The consolidation rate [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • The rate of complication due to the device [ Time Frame: 6 months after surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • PMA score [ Time Frame: 3 and 6 months after surgery ] [ Designated as safety issue: No ]
  • operating time [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
  • The duration of the use of the amplifier of brilliancy during the intervention [ Time Frame: during the surgery ] [ Designated as safety issue: No ]
  • The radiological position of the device [ Time Frame: 5 days, 3 and 6 months ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703716

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

No publications provided

Responsible Party: Integra LifeSciences Services
ClinicalTrials.gov Identifier: NCT00703716     History of Changes
Other Study ID Numbers: RECON-EMEA-06
Study First Received: June 20, 2008
Last Updated: October 9, 2012
Health Authority: France: Institutional Ethical Committee

Keywords provided by Integra LifeSciences Services:
mini-invasive
dynamic screw-plate
Surfix
Lock-screw

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

ClinicalTrials.gov processed this record on August 20, 2014