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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
Ahmed Saeed Younis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional screening trial for Hip Fractures

Eligibility Criteria

60 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 2, 2019
    Last Updated
    September 13, 2019
    Sponsor
    Ahmed Saeed Younis
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    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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