Femoral Shaft FractureFEOSNCT03251534
Contribution of Stereography (EOS Imaging System) in the Quantification of Femoral Shaft Fractures.
An observational study of Femoral Shaft Fracture, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Femoral Shaft Fracture
- What is being tested?
- Centromedullary nailing
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Sep 2018
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with surgery of femoral shaft fracture treated by nails
Who may be able to join
- Patients aged at least 16 years (parental agreement signed for minors) or adults at the time of data collection
- Patients with a femoral shaft fractures since january 2014
- Patients with a post-nailing femoral shaft fracture
- Patients with unilateral fracture
- Patients with regional origin allowing a follow-up in Grenoble center
Who cannot join
- Patients who refuse to sign a non-objective form
- Patients with femoral shaft fracture untreted with nails
Trial locations and contacts
1 site in 1 country.
France1 site
Orthopedic and Trauma Department, University Hospital, Grenoble Alpes
Grenoble, 38043
About this study
Official title: Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients
This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.
Read the detailed description
The study is based on the collection of clinical and imaging data (using EOS imaging system) necessary for the follow-up of patients who have benefited, most often in the emergency, of a centromedullary nailing of the femoral shaft. The study does not lead to any further examination for the patient since they are followed until the removal of the material, which usually takes place 24 months after the fracture episode. This observational and pilot study is monocentric, prospective on a continuous series of 40 patients.
- Conditions
- Femoral Shaft Fracture
- Being tested
- Centromedullary nailing
- Keywords
- Eos imaging stereography, Centromedullary nailing, Quantification of malunions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centromedullary nailingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative evaluation of rotational disturbances
Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.
Measured: 24 months
Secondary outcomes (11)
Correlation of the rotation disorder with the clinical condition of the patient.
Rotation disorder (angle in degree).
Measured: 24 months
Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).
Shortening or lengthening of the entire operative limb and of the femur alone (measured in mm), recorded in a standardized and comparative way compared to the healthy side, by the EOS © software
Measured: 24 months
Correlation of shortening or limb lengthening with the clinical condition of the patient.
Shortening or lengthening of limb (measured in mm).
Measured: 24 months
Quantitative evaluation of the varus-valgus (lateral-medial plane).
Varus-valgus (angle in degree), taken standardized and comparative way compared to the healthy side, by the EOS © software.
Measured: 24 months
Correlation of the varus-valgus with the clinical condition of the patient
Varus-valgus (angle in degree).
Measured: 24 months
Quantitative evaluation of the flessum-recurvatum
Flessum-recurvatum (angle in degree), measured in standardized and comparative way compared to the healthy side, by the EOS © software.
Measured: 24 months
Correlation of the flessum-recurvatum with the clinical condition of the patient.
Flessum-recurvatum (angle in degree)
Measured: 24 months
Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures
Rotational disturbance (angle in degree)
Measured: 24 months
Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.
Shortening or limb lengthening (measured in mm).
Measured: 24 months
Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures
Varus-valgus (angle in degree).
Measured: 24 months
Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures
Flessum-recurvatum (angle in degree).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Shaft 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Tonetti Jerôme, MD, PhD, Principal investigator, Orthopedic and Trauma department, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251534
- Sponsor's protocol ID
- DCIC-1550
- Acronym
- FEOS
- Status last verified
- Sep 2018
- First submitted
- 11 Aug 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Stereography in the Quantification of Malunions Femoral Shaft Fractures Operated by Centromedullary Nailing. A Case Serie of 40 Patients
- ClinicalTrials.gov ID
- NCT03251534
- Acronym / sponsor ID
- FEOS / DCIC-1550
- Conditions
- Femoral Shaft Fracture
- Keywords
- Eos imaging stereography, Centromedullary nailing, Quantification of malunions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 Aug 2017 (actual)
- 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.
This observational study is a collection of clinical and imaging data of patients with a femoral shaft fracture treated by nails. The aim of this research is the contribution of the EOS imaging system in the quantification of malunions.
Detailed description
The study is based on the collection of clinical and imaging data (using EOS imaging system) necessary for the follow-up of patients who have benefited, most often in the emergency, of a centromedullary nailing of the femoral shaft. The study does not lead to any further examination for the patient since they are followed until the removal of the material, which usually takes place 24 months after the fracture episode. This observational and pilot study is monocentric, prospective on a continuous series of 40 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with surgery of femoral shaft fracture treated by nails
Key inclusion criteria (5 listed)
- Patients aged at least 16 years (parental agreement signed for minors) or adults at the time of data collection
- Patients with a femoral shaft fractures since january 2014
- Patients with a post-nailing femoral shaft fracture
- Patients with unilateral fracture
- Patients with regional origin allowing a follow-up in Grenoble center
Key exclusion criteria (2 listed)
- Patients who refuse to sign a non-objective form
- Patients with femoral shaft fracture untreted with nails
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centromedullary nailing | Procedure or surgery | – |
Primary outcome
Quantitative evaluation of rotational disturbances
Time frame: 24 months
Rotation disorder (degree angle), measured in a standardized and comparative way compared to the healthy side, by the EOS © software.
11 secondary outcomes
Correlation of the rotation disorder with the clinical condition of the patient.
Time frame: 24 months
Quantitative evaluation of the shortening or the lengthening of the operated limb (cranio-caudal plane).
Time frame: 24 months
Correlation of shortening or limb lengthening with the clinical condition of the patient.
Time frame: 24 months
Quantitative evaluation of the varus-valgus (lateral-medial plane).
Time frame: 24 months
Correlation of the varus-valgus with the clinical condition of the patient
Time frame: 24 months
Quantitative evaluation of the flessum-recurvatum
Time frame: 24 months
Correlation of the flessum-recurvatum with the clinical condition of the patient.
Time frame: 24 months
Idendification of the main risk factors of post-nailing rotational disturbances of femoral shaft fractures
Time frame: 24 months
Identification of the main risk factors of limb shortening or lengthening (cranio-caudal plane) after femoral nailing of femoral shaft fractures.
Time frame: 24 months
Identification of the main risk factors for the varus-valgus (lateral-medial plane) after femoral nailing of fhe femoral shaft fractures
Time frame: 24 months
Identification of the main risk factors of the flessum-recurvatum after femoral nailing of fhe femoral shaft fractures
Time frame: 24 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 10 Sep 2018.
- Clinical Investigation Centre for Innovative Technology NetworkLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Femoral Shaft Fracture
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Rehabilitation After Lower Extremity Nailing Trial
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Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Femoral Shaft Fractures
Femoral Shaft Fractures, Femur Fractures
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Feasibility of Structured Resistance Training After Lower Extremity Fracture
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Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures
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Assessing Bone Fracture Healing Effect of Almonds
Femur Shaft Fracture, Tibia Fractures
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.
Tonetti Jerôme, MD, PhD principal investigator
Orthopedic and Trauma department, University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Shaft Fracture, run by University Hospital, Grenoble at 1 site 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 5 inclusion and 2 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 10 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Quantitative evaluation of rotational disturbances (time frame: 24 months). 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 10 Sep 2018.