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

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05871866
Collaborator
(none)
20
1
24
0.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: minimally invasive internal fixation device "infix"
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of a Minimally Invasive Internal Fixation Device for Treatment of Unstable Pelvic Ring Fractures
Actual Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Outcome Measures

Primary Outcome Measures

  1. advantages using INFIX [6 months]

    good patient tolerance

  2. union [1 yea]

    radiological

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohamed Essam Ahmed, Assistant lecturer, Sohag University
ClinicalTrials.gov Identifier:
NCT05871866
Other Study ID Numbers:
  • soh-Med-23-04-01MD
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2023