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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

Study Description
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Brief Summary:
To assess the importance Of Ct scan in the prediction of fixation failure of per-trochanteric fractures

Condition or disease Intervention/treatment Phase
Hip Fractures Sensitivity Computed Tomography Scan Radiation: CT scan Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Sensitivity of CT-scan as a Predictor of Fixation Failure in Per-trochanteric Fractures
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. CT scan lateral wall integrity (thickness measurement) [ Time Frame: one year ]
    in millimeters


Secondary Outcome Measures :
  1. Patients' history (e.g. Charlson comorbidity index) and demographics [ Time Frame: one year ]
    patients, demographics

  2. CT scan detected comminution [ Time Frame: one year ]
  3. QCT measurement of BMD [ Time Frame: one year ]
    QCT radiological measure of bone mineral density

  4. Fixation quality [ Time Frame: one year ]
    expert opinion in fixation quality

  5. Functional and patient reported outcome scores [ Time Frame: one year ]
    e.g Harris hip score HHS

  6. Postoperative complications [ Time Frame: one year ]
    e.g. lag cut out, breal through


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091776


Contacts
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Contact: Ahmed Younis, Dr. 201012370677 ahmed.s.younis@med.asu.edu.eg
Contact: Radwan Abdel Hamid, Dr. 201272221906 dr_radwan05@yahoo.com

Sponsors and Collaborators
Ahmed Saeed Younis
Investigators
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Principal Investigator: Radwan Metwally, Dr. Ain Shams University
More Information
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Responsible Party: Ahmed Saeed Younis, Registrar of orthopaedic surgery, Ain Shams University
ClinicalTrials.gov Identifier: NCT04091776     History of Changes
Other Study ID Numbers: 12376593
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Immune System Diseases
Femoral Fractures
Hip Injuries
Leg Injuries