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The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

Primary Purpose

Unstable Pelvic Fractures

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
minimally invasive internal fixation device "infix"
Sponsored by
Sohag University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unstable Pelvic Fractures

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who had APC-II Patients who had APC-III Patients who had LC - II Patients who had LC -III Exclusion Criteria: Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases. Open fractures. Stable pelvic ring fractures. Patients who had combined acetabular fractures Patients who had a hernia or previous lower abdominal surgery. Pregnancy.

Sites / Locations

  • Sohag University HospitalRecruiting

Outcomes

Primary Outcome Measures

advantages using INFIX
good patient tolerance
union
radiological

Secondary Outcome Measures

Full Information

First Posted
May 15, 2023
Last Updated
May 15, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05871866
Brief Title
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
Official Title
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Pelvic fractures are common presentations to major trauma centers and are associated with significant morbidity in polytrauma patients. Traditional open reduction and internal fixation is associated with a high incidence of surgical morbidity, while external fixators, used for both temporary stabilisation and as definitive management, have a complication rate of up to 62% [4], with poor patient tolerance, pin site infection and aseptic loosening the more commonly documented complications in the literature. Minimally invasive techniques have become more popular recently in the management of pelvic injuries due to their lower incidence of surgical morbidity. The application of a pelvic internal fixator (INFIX) has been presented as a comparable alternative to external fixation of anterior pelvic ring injuries.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unstable Pelvic Fractures

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
minimally invasive internal fixation device "infix"
Intervention Description
An INFIX involves the insertion of spinal pedicle screws in the anterior pelvis (supra-acetabular entry) and the placement of a connecting rod in the subcutaneous tissue of the patient
Primary Outcome Measure Information:
Title
advantages using INFIX
Description
good patient tolerance
Time Frame
6 months
Title
union
Description
radiological
Time Frame
1 yea

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who had APC-II Patients who had APC-III Patients who had LC - II Patients who had LC -III Exclusion Criteria: Patients who had immature skeletons or medical contraindications such as combined neurovascular injuries and uncontrolled medical diseases. Open fractures. Stable pelvic ring fractures. Patients who had combined acetabular fractures Patients who had a hernia or previous lower abdominal surgery. Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed E Ahmed, assistant lecteure
Phone
01007422680
Email
mohamed.essam@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Elshazly s Mousa, professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
magdy m Amin, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31250805
Citation
Steer R, Balendra G, Matthews J, Wullschleger M, Reidy J. The use of anterior subcutaneous internal fixation (INFIX) for treatment of pelvic ring injuries in major trauma patients, complications and outcomes. SICOT J. 2019;5:22. doi: 10.1051/sicotj/2019019. Epub 2019 Jun 28.
Results Reference
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PubMed Identifier
30095676
Citation
Lee C, Sciadini M. The Use of External Fixation for the Management of the Unstable Anterior Pelvic Ring. J Orthop Trauma. 2018 Sep;32 Suppl 6:S14-S17. doi: 10.1097/BOT.0000000000001251.
Results Reference
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PubMed Identifier
27825365
Citation
Hoskins W, Bucknill A, Wong J, Britton E, Judson R, Gumm K, Santos R, Sheehy R, Griffin X. A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures. J Orthop Surg Res. 2016 Nov 8;11(1):135. doi: 10.1186/s13018-016-0468-9.
Results Reference
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PubMed Identifier
23995332
Citation
Muller FJ, Stosiek W, Zellner M, Neugebauer R, Fuchtmeier B. The anterior subcutaneous internal fixator (ASIF) for unstable pelvic ring fractures: clinical and radiological mid-term results. Int Orthop. 2013 Nov;37(11):2239-45. doi: 10.1007/s00264-013-2032-0. Epub 2013 Aug 31.
Results Reference
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The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures

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