NCT05354531

Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

With a prospective case series study of 15 patients The aim of this study is to estimate the clinical outcomes in patients with unstable anterior pelvic ring fractures ( B\&C ) after treatment with (INFIX)

Detailed description

Unstable pelvic ring fractures are usually associated with high energy trauma. They account for about 1.5-3.9% of all fractures, but they have a high rate of morbidity and mortality. Although the posterior pelvic ring provides the main stability (60%), the anterior ring still account for 40% of stability fracture pelvis B \&C according to tiles classification require fixation of the anterior ring or anterior-posterior ring simultaneously. The external fixator is the most widely used treatment for initial and temporary stabilization of anterior pelvic ring injury, especially in emergency situations. It can be quickly placed and can easily stabilize the disrupted pelvic ring and decrease pelvic cavity haemorrhage. However, many clinical complications associated with the external fixator have been reported, including wound infection, loosening of the fixator, and impingement on the skin. Moreover, the anterior pelvic external fixator limits patients' daily activities, such as sitting, lying in the lateral position, rolling over, and sexual intercourse Recently, anterior subcutaneous internal fixator (INFIX) was proposed by several scholars to treat anterior pelvic ring injury. INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care . INFIX was initially designed as an alternative to the external fixator, but recently its indications have been expanded and multiple complications have been reported.

Conditions

• Pelvic Fracture

Interventions

Type	Name	Description
PROCEDURE	anterior subcutaneous internal fixator ( INFIX)	INFIX was invented based upon the same biomechanical principle as the traditional external fixator, but it is placed subcutaneously. It proved to be stiffer than the traditional external fixator, and at the same time eliminates the open pin tracts, which increased the infection rate and nursing care

Timeline

• Start date: 2022-03-02
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2022-04-29
• Last updated: 2025-05-30

Locations

2 sites across 1 country: Egypt