|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00703716 |
|
Date of registration:
|
20/06/2008 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
TRAUMAX |
|
Scientific title:
|
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX |
|
Date of first enrolment:
|
May 2008 |
|
Target sample size:
|
190 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00703716 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Cohort, Time Perspective: Prospective
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
CHIRON Philippe |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU Rangueil, Toulouse, FRANCE |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Hip Fracture
|
|
Primary Outcome(s)
|
|
The rate of complication due to the device
[Time Frame: 6 months after surgery]
|
|
The consolidation rate
[Time Frame: 6 months after surgery]
|
|
Secondary Outcome(s)
|
|
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]
|
|
operating time
[Time Frame: during the surgery]
|
|
PMA score
[Time Frame: 3 and 6 months after surgery]
|
|
The radiological position of the device
[Time Frame: 5 days, 3 and 6 months]
|
|
The duration of the use of the amplifier of brilliancy during the intervention
[Time Frame: during the surgery]
|
|
Secondary ID(s)
|
|
RECON-EMEA-06
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|