Clinical trial NCT05354531: Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions
Official title: Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Fracture
Keywords: pelvic ring fractures
INFIX
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group of 20 cases should be managed by INFIX for their pelvic ring disruption
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Majeed score
timeFrame: After 3 months
Secondary outcomes:
measure: Time to surgery
timeFrame: Within the first week
measure: Radiology dose
timeFrame: Within the first week
measure: Procedure time
timeFrame: Within the first week
measure: Incidence and rate of adverse events
timeFrame: After 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Orthopedic and trauma department Assiut university
city: Assiut
country: Egypt
facility: Orthopedic and traumatology department Assiut university hospital
Study officials:
affiliation: Orthopedic surgery department ,Assiut university
name: Osama Farouk, Prof
role: STUDY_CHAIR
References:
citation: Merriman DJ, Ricci WM, McAndrew CM, Gardner MJ. Is application of an internal anterior pelvic fixator anatomically feasible? Clin Orthop Relat Res. 2012 Aug;470(8):2111-5. doi: 10.1007/s11999-012-2287-6.