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Completed

NCT Number: NCT05354531

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

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)

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopedic and trauma department Assiut university, Asyut, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anterior subcutaneous internal fixator ( INFIX)

Procedure

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

Primary outcomes

  1. Majeed score

    Time frame: After 3 months

    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).

Secondary outcomes

  1. Time to surgery

    Time frame: Within the first week

    We will assess the time taken for the patient to be in the operation

  2. Radiology dose

    Time frame: Within the first week

    Sum of radiology dose taken intraoperatively

  3. Procedure time

    Time frame: Within the first week

    Time taken intraoperatively

  4. Incidence and rate of adverse events

    Time frame: After 6 months

    Any complications or problems should be assessed

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2022
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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