CT Scan in Per-trochanteric Fractures

NCT04091776 | Unknown

• 1 other identifier: 12376593
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hip Fractures; Sensitivity; Computed Tomography Scan

Outcome Measures

Primary Outcomes (1)

• CT scan lateral wall integrity (thickness measurement)

  in millimeters

  one year

Secondary Outcomes (6)

• Patients' history (e.g. Charlson comorbidity index) and demographics

  one year

• CT scan detected comminution

  one year

• QCT measurement of BMD

  one year

• Fixation quality

  one year

• Functional and patient reported outcome scores

  one year

Interventions

CT scan RADIATION

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

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known pathological fractures otherwise osteoporosis
• Prisoner
• Unable / unwilling to provide consent

Sponsors & Collaborators

• Ahmed Saeed Younis: lead

MeSH Terms

Conditions

Hip Fractures; Hypersensitivity

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Immune System Diseases

Study Officials

• Radwan Metwally, Dr.

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Younis, Dr.

CONTACT

201012370677; ahmed.s.younis@med.asu.edu.eg

Radwan Abdel Hamid, Dr.

CONTACT

201272221906; dr_radwan05@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Registrar of orthopaedic surgery

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 17, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share