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Clinical Trials/NCT05871866
NCT05871866
Recruiting
Not Applicable

The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Sohag University1 site in 1 country20 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unstable Pelvic Fractures
Sponsor
Sohag University
Enrollment
20
Locations
1
Primary Endpoint
union
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature.

Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
January 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohamed Essam Ahmed

Assistant lecturer

Sohag University

Eligibility Criteria

Inclusion Criteria

  • Patients who had APC-II
  • Patients who had APC-III
  • Patients who had LC - II
  • Patients who had LC -III

Exclusion Criteria

  • Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases.
  • Open fractures.
  • Stable pelvic ring fractures.
  • Patients who had combined acetabular fractures
  • Patients who had a hernia or previous lower abdominal surgery.
  • Pregnancy.

Outcomes

Primary Outcomes

union

Time Frame: 1 yea

radiological

advantages using INFIX

Time Frame: 6 months

good patient tolerance

Study Sites (1)

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