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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05354531
Enrollment
20
Registered
2022-04-29
Start date
2022-03-02
Completion date
2025-03-11
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Fracture

Keywords

pelvic ring fractures, INFIX

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.

Interventions

PROCEDUREanterior 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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Masking description

Those previously mentioned cases should be assessed clinically and radiologically

Intervention model description

One group of 20 cases should be managed by INFIX for their pelvic ring disruption

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Majeed scoreAfter 3 monthsMajeed 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).

Secondary

MeasureTime frameDescription
Time to surgeryWithin the first weekWe will assess the time taken for the patient to be in the operation
Radiology doseWithin the first weekSum of radiology dose taken intraoperatively
Procedure timeWithin the first weekTime taken intraoperatively
Incidence and rate of adverse eventsAfter 6 monthsAny complications or problems should be assessed

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026