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

Pelvic Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05354531
• Other study ID #: INFIX
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: January 2025

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Pelvic Fracture

Intervention

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

Locations

Country	Name	City	State
Egypt	Orthopedic and trauma department Assiut university	Assiut
Egypt	Orthopedic and traumatology department Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 3 months
Secondary	Time to surgery	We will assess the time taken for the patient to be in the operation	Within the first week
Secondary	Radiology dose	Sum of radiology dose taken intraoperatively	Within the first week
Secondary	Procedure time	Time taken intraoperatively	Within the first week
Secondary	Incidence and rate of adverse events	Any complications or problems should be assessed	After 6 months