CT Scan in Per-trochanteric Fractures

NCT ID: NCT04091776

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2021-02-28

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

Conditions

Hip Fractures; Sensitivity; Computed Tomography Scan

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Interventions

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

Intervention Type: RADIATION

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahmed Saeed Younis

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Saeed Younis

Registrar of orthopaedic surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Radwan Metwally, Dr.

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Central Contacts

Ahmed Younis, Dr.

Role: CONTACT

ahmed.s.younis@med.asu.edu.eg

201012370677

Radwan Abdel Hamid, Dr.

Role: CONTACT

dr_radwan05@yahoo.com

201272221906

Other Identifiers

12376593

Identifier Type: -

Identifier Source: org_study_id