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

NCT05354531 | Completed

• 1 other identifier: INFIX
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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)

Conditions

Pelvic Fracture

Keywords

pelvic ring fractures; INFIX

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time to surgery

  Within the first week

• Radiology dose

  Within the first week

• Procedure time

  Within the first week

• Incidence and rate of adverse events

  After 6 months

Study Arms (1)

INFIX group

EXPERIMENTAL

Those group of cases will be managed by INFIX for their pelvic ring disruption

Procedure: anterior subcutaneous internal fixator ( INFIX)

Interventions

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

INFIX group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• associated comorbidities preventing surgery.
• pelvic fracture associated with iliac bones fracture
• combined pelvis and acetabulum fracture.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (2)

Orthopedic and trauma department Assiut university

Asyut, 71511, Egypt

Location

Orthopedic and traumatology department Assiut university hospital

Asyut, 71511, Egypt

Location

Related 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.

  PMID: 22383020 BACKGROUND

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Osama Farouk, Prof

  Orthopedic surgery department ,Assiut university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Those previously mentioned cases should be assessed clinically and radiologically
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor Osama Farouk Head of trauma unit in department of orthopedic surgery Assiut university

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

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: April 29, 2022
• Study Start: March 2, 2022
• Primary Completion: March 11, 2025
• Study Completion: March 11, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)