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
About this trial
This is an interventional treatment trial for Unstable Pelvic Fractures
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.
Sites / Locations
- Sohag University HospitalRecruiting
Outcomes
Primary Outcome Measures
advantages using INFIX
good patient tolerance
union
radiological
Secondary Outcome Measures
Full Information
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
background
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
background
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
background
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
background
Learn more about this trial
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
We'll reach out to this number within 24 hrs