Hip FractureTRAUMAXNCT00703716
Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
An observational study of Hip Fracture, run by Integra LifeSciences Services at 10 sites in France.
Trial summary
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- How many people
- 190 participants
- Where
- 10 sitesFrance
- Study dates
- May 2008to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
Who may be able to join
- Man or woman
- Age > 18
- with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Hôpital d'Instruction des Armées R. Picqué
Bordeaux
CHU La Cavale Blanche
Brest
Centre Hospitalier Départemental de Vendée
La Roche-sur-Yon
Centre Hospitalier du Nord Mayenne
Mayenne
CHU Nantes
Nantes
Hopital Saint Antoine
Paris
Clinique de l'alliance
Saint-Cyr-sur-Loire
Nouvelle Clinique de l'Union et du Vaurais
Saint-Jean
CHU Toulouse
Toulouse
Centre Hospitalier Saint Cyr
Villeneuve-sur-Lot
About this study
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX
Read the 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.
- Conditions
- Hip Fracture
- Keywords
- mini-invasive, dynamic screw-plate, Surfix, Lock-screw
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
The consolidation rate
Measured: 6 months after surgery
The rate of complication due to the device
Measured: 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.
Measured: 3 and 6 months after surgery
PMA score
Measured: 3 and 6 months after surgery
operating time
Measured: during the surgery
The duration of the use of the amplifier of brilliancy during the intervention
Measured: during the surgery
The radiological position of the device
Measured: 5 days, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Services
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- CHIRON Philippe, Principal investigator, CHU Rangueil, Toulouse, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703716
- Sponsor's protocol ID
- RECON-EMEA-06
- Acronym
- TRAUMAX
- Status last verified
- Sep 2014
- First submitted
- 20 Jun 2008
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stabilization of Trochanteric Fracture Using a Screw-plate TRAUMAX
- ClinicalTrials.gov ID
- NCT00703716
- Acronym / sponsor ID
- TRAUMAX / RECON-EMEA-06
- Conditions
- Hip Fracture
- Keywords
- mini-invasive, dynamic screw-plate, Surfix, Lock-screw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Integra LifeSciences ServicesIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the stabilization of trochanteric fracture using a screw-plate TRAUMAX
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
Key inclusion criteria (3 listed)
- Man or woman
- Age > 18
- with a trochanteric fracture whom surgeon advised the use of a screw-plate TRAUMAX
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The consolidation rate
Time frame: 6 months after surgery
The rate of complication due to the device
Time frame: 6 months after surgery
5 secondary outcomes
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
PMA score
Time frame: 3 and 6 months after surgery
operating time
Time frame: during the surgery
The duration of the use of the amplifier of brilliancy during the intervention
Time frame: during the surgery
The radiological position of the device
Time frame: 5 days, 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHIRON Philippe principal investigator
CHU Rangueil, Toulouse, FRANCE
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by Integra LifeSciences Services at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The consolidation rate (time frame: 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.