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

Sohag University

Status: Enrolling

Conditions: Unstable Pelvic Fractures

Treatments: Procedure: minimally invasive internal fixation device "infix"

Study type: Interventional

Funder types: Other

Identifiers

NCT05871866

soh-Med-23-04-01MD

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)