Clinical trial NCT04091776: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Fractures
Sensitivity
Computed Tomography Scan
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

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

Primary outcomes:
measure: CT scan lateral wall integrity (thickness measurement)
timeFrame: one year
Secondary outcomes:
measure: Patients' history (e.g. Charlson comorbidity index) and demographics
timeFrame: one year
measure: CT scan detected comminution
timeFrame: one year
measure: QCT measurement of BMD
timeFrame: one year
measure: Fixation quality
timeFrame: one year
measure: Functional and patient reported outcome scores
timeFrame: one year
measure: Postoperative complications
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Radwan Metwally, Dr.
role: PRINCIPAL_INVESTIGATOR
References: