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

Study Overview
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Brief Summary
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With a prospective case series study of 30 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
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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.

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

Conditions
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Pelvic Fracture

Intervention / Treatment
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* Procedure: anterior subcutaneous internal fixator ( INFIX)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: One group of 30 cases should be managed by INFIX for their pelvic ring disruption
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INFIX group<br>Those group of cases will be managed by INFIX for their pelvic ring disruption | Procedure: anterior subcutaneous internal fixator ( INFIX)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Majeed score | Majeed rating scale will be used to evaluate the functional outcome. Patients will be followed up by phone or at the clinic. functional recovery will be scored by asking the rating scale questions. These questions including the subjective feelings of pain, return to the work, the feelings of sitting, sexual intercourse, standing, walking distance, and the condition of gait. The aggregate score will be classified as excellent (>85), good (70-84), fair (55-69), or poor (<55). | After 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to surgery | We will assess the time taken for the patient to be in the operation | Within the first week | 
| Radiology dose | Sum of radiology dose taken intraoperatively | Within the first week | 
| Procedure time | Time taken intraoperatively | Within the first week | 
| Incidence and rate of adverse events | Any complications or problems should be assessed | After 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic ring fractures, INFIX