Skip to main content
Clinical Trials/NCT05871866
NCT05871866UnknownNot Applicable

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

Sohag University1 site in 1 country20 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
20
Locations
1
Primary Endpoint
union

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Essam Ahmed

Assistant lecturer

Sohag University

Study Sites (1)

Loading locations...

Similar Trials