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

Primary Purpose

Pelvic Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
anterior subcutaneous internal fixator ( INFIX)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Pelvic Fracture focused on measuring pelvic ring fractures, INFIX

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Orthopedic and trauma department Assiut university

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

INFIX group

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Time to surgery
We will assess the time taken for the patient to be in the operation
Radiology dose
Sum of radiology dose taken intraoperatively
Procedure time
Time taken intraoperatively
Incidence and rate of adverse events
Any complications or problems should be assessed

Full Information

First Posted
March 1, 2022
Last Updated
August 14, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05354531
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
With a prospective case series study of 30 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Fracture
Keywords
pelvic ring fractures, INFIX

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One group of 30 cases should be managed by INFIX for their pelvic ring disruption
Masking
None (Open Label)
Masking Description
Those previously mentioned cases should be assessed clinically and radiologically
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
INFIX group
Arm Type
Experimental
Arm Description
Those group of cases will be managed by INFIX for their pelvic ring disruption
Intervention Type
Procedure
Intervention Name(s)
anterior subcutaneous internal fixator ( INFIX)
Intervention Description
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 Outcome Measure Information:
Title
Majeed score
Description
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).
Time Frame
After 4 weeks
Secondary Outcome Measure Information:
Title
Time to surgery
Description
We will assess the time taken for the patient to be in the operation
Time Frame
Within the first week
Title
Radiology dose
Description
Sum of radiology dose taken intraoperatively
Time Frame
Within the first week
Title
Procedure time
Description
Time taken intraoperatively
Time Frame
Within the first week
Title
Incidence and rate of adverse events
Description
Any complications or problems should be assessed
Time Frame
After 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kyrillos Talaat, resident
Phone
+201024491719
Email
kyrillostal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Badran, Ass.Prof.Dr
Phone
+201000341878
Email
m_badran80@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Farouk, Prof
Organizational Affiliation
Orthopedic surgery department ,Assiut university
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedic and trauma department Assiut university
City
Assiut
ZIP/Postal Code
71511
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
22383020
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.
Results Reference
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Outcome of the Anterior Subcutaneous Internal Fixator (INFIX) for Pelvic Ring Disruptions

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