Neck of Femur FractureNCT02577081
Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly.
A study testing CAT scan (CT scan) in people with Neck of Femur Fracture, run by Meir Medical Center at 1 site in Israel.
Trial summary
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT… Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Neck of Femur Fracture
- What is being tested?
- CAT scan (CT scan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to Oct 2020
- Phase
- Interventional
- 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 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70-90 years old patients admitted to the orthopaedic department after neck of femur fracture.
- No contra lateral femur pathology.
- Consent for pelvis and femurs CAT scan.
Who cannot join
- Known pathology in other lower limbs joints in the body.
- History of previous fractures or operations in lower limbs.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Meir medical center
Kfar Saba, 44538
Niv Marom, MD, +972-9-7471888, niv.marom@gmail.com
About this study
Official title: Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly. CT Based Study.
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.
Read the detailed description
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. literature shows that around 10 percent of those who fracture their femoral neck for the first time will later fracture their contralateral neck of femur and in most cases with the same fracture characteristics. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.
- Conditions
- Neck of Femur Fracture
- Being tested
- CAT scan (CT scan)
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT scan (CT scan)Other
all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.
| Study group | Role | What they receive |
|---|---|---|
| CAT scan | Experimental | A CAT scan will be done for all participants. The scan will include the pelvis and 2 femurs. Receives: Other: CAT scan (CT scan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The risk of a contralateral neck of femur fracture
A patient specific analysis based on CT scan and finite element analysis will be done on both neck of femurs.
Measured: 5 years
Secondary outcomes (1)
3 dimensional charataristics of the neck of femur fracture
The CAT scan will provide 3 dimensional characteristics of the current neck of femur fracture as well as the predicted one in the contralateral femur. The fracture will be described using orthopaedic classifications, such as: garden classification for neck of femur fractures and AO classification for intertrochanteric fractures of the femur.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJan 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck of Femur 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Responsible party
- Principal investigator, niv marom, Meir Medical Center
- Investigators
- niv marom, MD, Study chair, meir medical cenrter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577081
- Sponsor's protocol ID
- 0163-15-MMC
- Status last verified
- Sep 2016
- First submitted
- 24 Sep 2015
- Last updated
- 20 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gaumetou E, Zilber S, Hernigou P. Non-simultaneous bilateral hip fracture: epidemiologic study of 241 hip fractures. Orthop Traumatol Surg Res. 2011 Feb;97(1):22-7. doi: 10.1016/j.otsr.2010.07.011. Epub 2011 Jan 15.
PubMed 21239241Burgers PT, Zielinski SM, Mailuhu AK, Heetveld MJ, Verhofstad MH, Roukema GR, Patka P, Poolman RW, Van Lieshout EM; Dutch femoral neck fracture investigator group. Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients. Int Orthop. 2014 Nov;38(11):2335-42. doi: 10.1007/s00264-014-2447-2. Epub 2014 Aug 3.
PubMed 25086819Yosibash Z, Trabelsi N, Milgrom C. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J Biomech. 2007;40(16):3688-99. doi: 10.1016/j.jbiomech.2007.06.017. Epub 2007 Aug 13.
PubMed 17706228Yosibash Z, Tal D, Trabelsi N. Predicting the yield of the proximal femur using high-order finite-element analysis with inhomogeneous orthotropic material properties. Philos Trans A Math Phys Eng Sci. 2010 Jun 13;368(1920):2707-23. doi: 10.1098/rsta.2010.0074.
PubMed 20439270Trabelsi N, Yosibash Z, Wutte C, Augat P, Eberle S. Patient-specific finite element analysis of the human femur--a double-blinded biomechanical validation. J Biomech. 2011 Jun 3;44(9):1666-72. doi: 10.1016/j.jbiomech.2011.03.024. Epub 2011 Apr 15.
PubMed 21497354
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Risk of Contralateral Non Simultaneous Neck of Femur Fracture in the Elderly. CT Based Study.
- ClinicalTrials.gov ID
- NCT02577081
- Acronym / sponsor ID
- 0163-15-MMC
- Conditions
- Neck of Femur Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- Ben-Gurion University of the Negev
- Study start
- Jan 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 16 Oct 2015 (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.
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.
Detailed description
Neck of femur fractures are common in the elderly and are the source of significant morbidity and mortality. literature shows that around 10 percent of those who fracture their femoral neck for the first time will later fracture their contralateral neck of femur and in most cases with the same fracture characteristics. This study is based on a new technique developed in Ben Gurion University, with which investigators are able to asses the structural 3 dimensional strength of a bone by applying a unique simulation on a CAT scan of the bone. The purpose of this study is to evaluate the risk of a contralateral neck of femur fracture after the first neck of femur fracture and to estimate the potential fracture characteristics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAT scan | Experimental | Other: CAT scan (CT scan)A CAT scan will be done for all participants. The scan will include the pelvis and 2 femurs. |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70-90 years old patients admitted to the orthopaedic department after neck of femur fracture.
- No contra lateral femur pathology.
- Consent for pelvis and femurs CAT scan.
Key exclusion criteria (2 listed)
- Known pathology in other lower limbs joints in the body.
- History of previous fractures or operations in lower limbs.
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 |
|---|---|---|
| CAT scan (CT scan)all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required. | Other | CAT scan |
Primary outcome
The risk of a contralateral neck of femur fracture
Time frame: 5 years
A patient specific analysis based on CT scan and finite element analysis will be done on both neck of femurs.
1 secondary outcome
3 dimensional charataristics of the neck of femur fracture
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2016.
- Background: PubMed 21239241Gaumetou E, Zilber S, Hernigou P. Non-simultaneous bilateral hip fracture: epidemiologic study of 241 hip fractures. Orthop Traumatol Surg Res. 2011 Feb;97(1):22-7. doi: 10.1016/j.otsr.2010.07.011. Epub 2011 Jan 15.
- Background: PubMed 25086819Burgers PT, Zielinski SM, Mailuhu AK, Heetveld MJ, Verhofstad MH, Roukema GR, Patka P, Poolman RW, Van Lieshout EM; Dutch femoral neck fracture investigator group. Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of one thousand two hundred and fifty patients. Int Orthop. 2014 Nov;38(11):2335-42. doi: 10.1007/s00264-014-2447-2. Epub 2014 Aug 3.
- Background: PubMed 17706228Yosibash Z, Trabelsi N, Milgrom C. Reliable simulations of the human proximal femur by high-order finite element analysis validated by experimental observations. J Biomech. 2007;40(16):3688-99. doi: 10.1016/j.jbiomech.2007.06.017. Epub 2007 Aug 13.
- Background: PubMed 20439270Yosibash Z, Tal D, Trabelsi N. Predicting the yield of the proximal femur using high-order finite-element analysis with inhomogeneous orthotropic material properties. Philos Trans A Math Phys Eng Sci. 2010 Jun 13;368(1920):2707-23. doi: 10.1098/rsta.2010.0074.
- Background: PubMed 21497354Trabelsi N, Yosibash Z, Wutte C, Augat P, Eberle S. Patient-specific finite element analysis of the human femur--a double-blinded biomechanical validation. J Biomech. 2011 Jun 3;44(9):1666-72. doi: 10.1016/j.jbiomech.2011.03.024. Epub 2011 Apr 15.
- Individual participant dataSharing planned: No
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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.
niv marom, MD study chair
meir medical cenrter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAT scan (CT scan) in people with Neck of Femur Fracture, run by Meir Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 20 Sep 2016. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Niv Marom, M.D (+972-52-2228627, niv.marom@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The risk of a contralateral neck of femur fracture (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02577081, which also lists 5 linked publications.
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 20 Sep 2016.