Hip FracturesNCT04091776
CT Scan in Per-trochanteric Fractures
A study testing CT scan in people with Hip Fractures and Sensitivity, run by Ahmed Saeed Younis.
Trial summary
To assess the importance Of Ct scan in the prediction of fixation failure of per-trochanteric fractures Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Hip Fractures, Sensitivity, Computed Tomography Scan
- What is being tested?
- CT scan
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2020to Feb 2021
- 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 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years
- Pertrochanteric fracture requiring surgical treatment
- Ability to understand the content of the patient information
- Informed Consent Form (ICF)
- Willingness and ability to participate in the study
- Signed and dated IRB/ ECs-approved written informed Consent
- Mental capacity to comply with post-operative regimen, evaluation and data collection
- Ability to attend post-operative follow up visits
Who cannot join
- Known pathological fractures otherwise osteoporosis
- Prisoner
- Unable / unwilling to provide consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures
To assess the importance Of Ct scan in the prediction of fixation failure of per-trochanteric fractures
Read the detailed description
Recently, epidemiological studies had shown an increase in hip fractures with aging of the population. Osteoporosis had been defined by a mean of -2.5 SD upon DEXA scan, which is not a practical tool to use in patients with recent hip fractures until management of such fractures either with fixation or replacement. Also it have been found that assessment of osteoporosis using the Singh index is not a reliable method for osteoporosis diagnosis .
Osteoporosis may affect the decision making for dealing with per-trochanteric fractures as some surgeons prefer to do hip replacement for fear of fixation failure, while others still convinced that fixation with good reduction and appropriate placement of lag screw within a TAD less than 25mm is the best even with unstable types specially after the progress in proximal femoral nails .
CT scan can be used for osteoporosis measurement. Even it can detect stress fractures that are not dRecently, epidemiological studies had shown an increase in hip fractures with aging of the population . Osteoporosis had been defined by a mean of -2.5 SD upon DEXA scan , which is not a practical tool to use in patients with recent hip fractures until management of such fractures either with fixation or replacement. Also it have been found that assessment of osteoporosis using the Singh index is not a reliable method for osteoporosis diagnosis .
Osteoporosis may affect the decision making for dealing with per-trochanteric fractures as some surgeons prefer to do hip replacement for fear of fixation failure, while others still convinced that fixation with good reduction and appropriate placement of lag screw within a TAD less than 25mm is the best even with unstable types specially after the progress in proximal femoral nails .
CT scan can be used for osteoporosis measurement. Even it can detect stress fractures that are not diagnosed using DEXA scan. It can be used to assess BMD in specific regions like spine or hip in a quantitative manner that can be compared to the T score used with DEXA scan . Again It can assess the presence of comminution in the anterior and posterior cortices that might not be easy with x-rays. The thickness of the lateral wall can be better measured through CT scan which is a critical measure while deciding to fix trochanteric fractures using whether DHS or PFN .
The purpose of this prospective clinical cohort study is to assess the sensitivity of CT scan for localized osteoporosis detection that can be used in patients with hip fracture and detection of comminution and thin trochanteric lateral wall that might not be accessible with x-rays. And whether these independent factors could predict the fixation failure iagnosed using DEXA scan. It can be used to assess BMD in specific regions like spine or hip in a quantitative manner that can be compared to the T score used with DEXA scan . Again It can assess the presence of comminution in the anterior and posterior cortices that might not be easy with x-rays. The thickness of the lateral wall can be better measured through CT scan which is a critical measure while deciding to fix trochanteric fractures using whether DHS or PFN .
The purpose of this prospective clinical cohort study is to assess the sensitivity of CT scan for localized osteoporosis detection that can be used in patients with hip fracture and detection of comminution and thin trochanteric lateral wall that might not be accessible with x-rays. And whether these independent factors could predict the fixation failure
- Conditions
- Hip Fractures, Sensitivity, Computed Tomography Scan
- Being tested
- CT scan
- Medical subject headings
- Hip Fractures, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
- Quantitative CT scan to measure localized osteoporosis and detection of cortices comminution.
- Blinded surgeon decision as regard to replace or to fix using DHS or PFN (depending on x-rays data only).
- Pathological assessment of osteoporosis in retrieved bone in patients whom hip replacement was decided.
- Assessment of fixation failure in fixed fractures if occurred.
- Fixation failure is defined as:
5.1. Lag cut through 5.2. Lag cutout 5.3. Z-effect (lag penetration) 5.4. Non-union (within 6 months) 5.5. Loss of reduction with progressive varus deformity 5.6. Femoral fracture 5.7. Intra-operative fracture of lateral wall or anterior cortex
What is being measured
The primary outcome is the main question the study is designed to answer.
CT scan lateral wall integrity (thickness measurement)
in millimeters
Measured: one year
Secondary outcomes (6)
Patients' history (e.g. Charlson comorbidity index) and demographics
patients, demographics
Measured: one year
CT scan detected comminution
Measured: one year
QCT measurement of BMD
QCT radiological measure of bone mineral density
Measured: one year
Fixation quality
expert opinion in fixation quality
Measured: one year
Functional and patient reported outcome scores
e.g Harris hip score HHS
Measured: one year
Postoperative complications
e.g. lag cut out, breal through
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2019
- Study startJan 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmed Saeed Younis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Saeed Younis, Ain Shams University
- Investigators
- Radwan Metwally, Dr., Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091776
- Sponsor's protocol ID
- 12376593
- Status last verified
- Sep 2019
- First submitted
- 2 Sep 2019
- Last updated
- 17 Sep 2019
- 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 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures
- ClinicalTrials.gov ID
- NCT04091776
- Acronym / sponsor ID
- 12376593
- Conditions
- Hip Fractures, Sensitivity, Computed Tomography Scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahmed Saeed YounisUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 17 Sep 2019 (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.
To assess the importance Of Ct scan in the prediction of fixation failure of per-trochanteric fractures
Detailed description
Recently, epidemiological studies had shown an increase in hip fractures with aging of the population. Osteoporosis had been defined by a mean of -2.5 SD upon DEXA scan, which is not a practical tool to use in patients with recent hip fractures until management of such fractures either with fixation or replacement. Also it have been found that assessment of osteoporosis using the Singh index is not a reliable method for osteoporosis diagnosis .
Osteoporosis may affect the decision making for dealing with per-trochanteric fractures as some surgeons prefer to do hip replacement for fear of fixation failure, while others still convinced that fixation with good reduction and appropriate placement of lag screw within a TAD less than 25mm is the best even with unstable types specially after the progress in proximal femoral nails .
CT scan can be used for osteoporosis measurement. Even it can detect stress fractures that are not dRecently, epidemiological studies had shown an increase in hip fractures with aging of the population . Osteoporosis had been defined by a mean of -2.5 SD upon DEXA scan , which is not a practical tool to use in patients with recent hip fractures until management of such fractures either with fixation or replacement. Also it have been found that assessment of osteoporosis using the Singh index is not a reliable method for osteoporosis diagnosis .
Osteoporosis may affect the decision making for dealing with per-trochanteric fractures as some surgeons prefer to do hip replacement for fear of fixation failure, while others still convinced that fixation with good reduction and appropriate placement of lag screw within a TAD less than 25mm is the best even with unstable types specially after the progress in proximal femoral nails .
CT scan can be used for osteoporosis measurement. Even it can detect stress fractures that are not diagnosed using DEXA scan. It can be used to assess BMD in specific regions like spine or hip in a quantitative manner that can be compared to the T score used with DEXA scan . Again It can assess the presence of comminution in the anterior and posterior cortices that might not be easy with x-rays. The thickness of the lateral wall can be better measured through CT scan which is a critical measure while deciding to fix trochanteric fractures using whether DHS or PFN .
The purpose of this prospective clinical cohort study is to assess the sensitivity of CT scan for localized osteoporosis detection that can be used in patients with hip fracture and detection of comminution and thin trochanteric lateral wall that might not be accessible with x-rays. And whether these independent factors could predict the fixation failure iagnosed using DEXA scan. It can be used to assess BMD in specific regions like spine or hip in a quantitative manner that can be compared to the T score used with DEXA scan . Again It can assess the presence of comminution in the anterior and posterior cortices that might not be easy with x-rays. The thickness of the lateral wall can be better measured through CT scan which is a critical measure while deciding to fix trochanteric fractures using whether DHS or PFN .
The purpose of this prospective clinical cohort study is to assess the sensitivity of CT scan for localized osteoporosis detection that can be used in patients with hip fracture and detection of comminution and thin trochanteric lateral wall that might not be accessible with x-rays. And whether these independent factors could predict the fixation failure
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 60 years
- Pertrochanteric fracture requiring surgical treatment
- Ability to understand the content of the patient information
- Informed Consent Form (ICF)
- Willingness and ability to participate in the study
Key exclusion criteria (3 listed)
- Known pathological fractures otherwise osteoporosis
- Prisoner
- Unable / unwilling to provide consent
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 |
|---|---|---|
| CT scan1. Quantitative CT scan to measure localized osteoporosis and detection of cortices comminution. 2. Blinded surgeon decision as regard to replace or to fix using DHS or PFN (depending on x-rays data only). 3. Pathological assessment of osteoporosis in retrieved bone in patients whom hip replacement was decided. 4. Assessment of fixation failure in fixed fractures if occurred. 5. Fixation failure is defined as: 5.1. Lag cut through 5.2. Lag cutout 5.3. Z-effect (lag penetration) 5.4. Non-union (within 6 months) 5.5. Loss of reduction with progressive varus deformity 5.6. Femoral fracture 5.7. Intra-operative fracture of lateral wall or anterior cortex | Radiation | – |
Primary outcome
CT scan lateral wall integrity (thickness measurement)
Time frame: one year
in millimeters
6 secondary outcomes
Patients' history (e.g. Charlson comorbidity index) and demographics
Time frame: one year
CT scan detected comminution
Time frame: one year
QCT measurement of BMD
Time frame: one year
Fixation quality
Time frame: one year
Functional and patient reported outcome scores
Time frame: one year
Postoperative complications
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
- 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.
Radwan Metwally, Dr. principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A study testing CT scan in people with Hip Fractures and Sensitivity, run by Ahmed Saeed Younis.
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 8 inclusion and 3 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 17 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Ahmed Younis, Dr. (201012370677, ahmed.s.younis@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT scan lateral wall integrity (thickness measurement) (time frame: one year). 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 17 Sep 2019.