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CT Scan in Per-trochanteric Fractures

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ClinicalTrials.gov Identifier: NCT04091776
Recruitment Status : Not yet recruiting
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Saeed Younis, Ain Shams University

Tracking Information
First Submitted Date  ICMJE September 2, 2019
First Posted Date  ICMJE September 17, 2019
Last Update Posted Date September 17, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
CT scan lateral wall integrity (thickness measurement) [ Time Frame: one year ]
in millimeters
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2019)
  • Patients' history (e.g. Charlson comorbidity index) and demographics [ Time Frame: one year ]
    patients, demographics
  • CT scan detected comminution [ Time Frame: one year ]
  • QCT measurement of BMD [ Time Frame: one year ]
    QCT radiological measure of bone mineral density
  • Fixation quality [ Time Frame: one year ]
    expert opinion in fixation quality
  • Functional and patient reported outcome scores [ Time Frame: one year ]
    e.g Harris hip score HHS
  • Postoperative complications [ Time Frame: one year ]
    e.g. lag cut out, breal through
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CT Scan in Per-trochanteric Fractures
Official Title  ICMJE Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Hip Fractures
  • Sensitivity
  • Computed Tomography Scan
Intervention  ICMJE Radiation: CT scan
  1. 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

Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed Younis, Dr. 201012370677 ahmed.s.younis@med.asu.edu.eg
Contact: Radwan Abdel Hamid, Dr. 201272221906 dr_radwan05@yahoo.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091776
Other Study ID Numbers  ICMJE 12376593
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ahmed Saeed Younis, Ain Shams University
Study Sponsor  ICMJE Ahmed Saeed Younis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Radwan Metwally, Dr. Ain Shams University
PRS Account Ain Shams University
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP