CT Scan in Per-trochanteric Fractures

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04091776
• Other study ID #: 12376593
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: February 2021

Study information

• Verified date: September 2019
• Source: Ain Shams University
• Contact: Ahmed Younis, Dr.
• Phone: 201012370677
• Email: ahmed.s.younis[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the importance Of Ct scan in the prediction of fixation failure of per-trochanteric fractures

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Computed Tomography Scan
• Fractures, Bone
• Hip Fractures
• Hypersensitivity
• Sensitivity

Intervention

Radiation:
• CT scan
Quantitative CT scan to measure localized osteoporosis and detection of cortices comminution. Blinded surgeon decision as regard to replace or to fix using DHS or PFN (depending on x-rays data only). Pathological assessment of osteoporosis in retrieved bone in patients whom hip replacement was decided. Assessment of fixation failure in fixed fractures if occurred. 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ahmed Saeed Younis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT scan lateral wall integrity (thickness measurement)	in millimeters	one year
Secondary	Patients' history (e.g. Charlson comorbidity index) and demographics	patients, demographics	one year
Secondary	CT scan detected comminution		one year
Secondary	QCT measurement of BMD	QCT radiological measure of bone mineral density	one year
Secondary	Fixation quality	expert opinion in fixation quality	one year
Secondary	Functional and patient reported outcome scores	e.g Harris hip score HHS	one year
Secondary	Postoperative complications	e.g. lag cut out, breal through	one year