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

Assiut University

Status: Completed

Conditions: Pelvic Fracture

Treatments: Procedure: anterior subcutaneous internal fixator ( INFIX)

Study type: Interventional

Funder types: Other

Identifiers

NCT05354531

INFIX

Details and patient eligibility

About

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)

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• skeletally mature patient.
• type B2 / B3 & C1 pelvic fracture.
• open book B1 fracture with urogenital disruption.
• Patient with fatty tissue that cover pubic bones enable insertion of the rod.
• if there is a contraindication to Anterior symphyseal plating.

Exclusion criteria

• associated comorbidities preventing surgery.
• pelvic fracture associated with iliac bones fracture
• combined pelvis and acetabulum fracture.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

INFIX group

Experimental group

Description:

Those group of cases will be managed by INFIX for their pelvic ring disruption

Treatment:

Procedure: anterior subcutaneous internal fixator ( INFIX)