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Clinical Trials/NCT04091776
NCT04091776
Unknown
Not Applicable

Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures

Ahmed Saeed Younis0 sites60 target enrollmentJanuary 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Ahmed Saeed Younis
Enrollment
60
Primary Endpoint
CT scan lateral wall integrity (thickness measurement)
Last Updated
6 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 2020
End Date
February 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ahmed Saeed Younis
Responsible Party
Sponsor Investigator
Principal Investigator

Ahmed Saeed Younis

Registrar of orthopaedic surgery

Ain Shams University

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
  • Unable / unwilling to provide consent

Outcomes

Primary Outcomes

CT scan lateral wall integrity (thickness measurement)

Time Frame: one year

in millimeters

Secondary Outcomes

  • Functional and patient reported outcome scores(one year)
  • Postoperative complications(one year)
  • Patients' history (e.g. Charlson comorbidity index) and demographics(one year)
  • CT scan detected comminution(one year)
  • QCT measurement of BMD(one year)
  • Fixation quality(one year)

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