CT Scan in Per-trochanteric Fractures
Primary Purpose
Hip Fractures, Sensitivity, Computed Tomography Scan
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CT scan
Sponsored by
About this trial
This is an interventional screening trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Known pathological fractures otherwise osteoporosis
- Prisoner
- Unable / unwilling to provide consent
Sites / Locations
Outcomes
Primary Outcome Measures
CT scan lateral wall integrity (thickness measurement)
in millimeters
Secondary Outcome Measures
Patients' history (e.g. Charlson comorbidity index) and demographics
patients, demographics
CT scan detected comminution
QCT measurement of BMD
QCT radiological measure of bone mineral density
Fixation quality
expert opinion in fixation quality
Functional and patient reported outcome scores
e.g Harris hip score HHS
Postoperative complications
e.g. lag cut out, breal through
Full Information
NCT ID
NCT04091776
First Posted
September 2, 2019
Last Updated
September 13, 2019
Sponsor
Ahmed Saeed Younis
1. Study Identification
Unique Protocol Identification Number
NCT04091776
Brief Title
CT Scan in Per-trochanteric Fractures
Official Title
Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ahmed Saeed Younis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures, Sensitivity, Computed Tomography Scan
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
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
Primary Outcome Measure Information:
Title
CT scan lateral wall integrity (thickness measurement)
Description
in millimeters
Time Frame
one year
Secondary Outcome Measure Information:
Title
Patients' history (e.g. Charlson comorbidity index) and demographics
Description
patients, demographics
Time Frame
one year
Title
CT scan detected comminution
Time Frame
one year
Title
QCT measurement of BMD
Description
QCT radiological measure of bone mineral density
Time Frame
one year
Title
Fixation quality
Description
expert opinion in fixation quality
Time Frame
one year
Title
Functional and patient reported outcome scores
Description
e.g Harris hip score HHS
Time Frame
one year
Title
Postoperative complications
Description
e.g. lag cut out, breal through
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Known pathological fractures otherwise osteoporosis
Prisoner
Unable / unwilling to provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Younis, Dr.
Phone
201012370677
Email
ahmed.s.younis@med.asu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Radwan Abdel Hamid, Dr.
Phone
201272221906
Email
dr_radwan05@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Radwan Metwally, Dr.
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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CT Scan in Per-trochanteric Fractures
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