Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
TRAUMAX
1 other identifier
observational
190
1 country
10
Brief Summary
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2008
Typical duration for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 20, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedSeptember 11, 2014
September 1, 2014
2.6 years
June 20, 2008
September 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The consolidation rate
6 months after surgery
The rate of complication due to the device
6 months after surgery
Secondary Outcomes (5)
The evolution of the functional scores (Parker, ADL, Katz, Robinson) between before the fracture and after the intervention.
3 and 6 months after surgery
PMA score
3 and 6 months after surgery
operating time
during the surgery
The duration of the use of the amplifier of brilliancy during the intervention
during the surgery
The radiological position of the device
5 days, 3 and 6 months
Eligibility Criteria
Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
You may qualify if:
- Man or woman
- Age \> 18
- with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHIRON Philippe
CHU Rangueil, Toulouse, FRANCE
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2008
First Posted
June 23, 2008
Study Start
May 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
September 11, 2014
Record last verified: 2014-09