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CT Scan in Per-trochanteric Fractures

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04091776
Enrollment
60
Registered
2019-09-17
Start date
2020-01-31
Completion date
2021-02-28
Last updated
2019-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Computed Tomography Scan, Hip Fractures, Sensitivity

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

Interventions

RADIATIONCT 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

Sponsors

Ahmed Saeed Younis
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
CT scan lateral wall integrity (thickness measurement)one yearin millimeters

Secondary

MeasureTime frameDescription
CT scan detected comminutionone year
QCT measurement of BMDone yearQCT radiological measure of bone mineral density
Patients' history (e.g. Charlson comorbidity index) and demographicsone yearpatients, demographics
Functional and patient reported outcome scoresone yeare.g Harris hip score HHS
Postoperative complicationsone yeare.g. lag cut out, breal through
Fixation qualityone yearexpert opinion in fixation quality

Contacts

Primary ContactAhmed Younis, Dr.
ahmed.s.younis@med.asu.edu.eg201012370677
Backup ContactRadwan Abdel Hamid, Dr.
dr_radwan05@yahoo.com201272221906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026