Clinical trial NCT05871866: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Unstable Pelvic Fractures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: advantages using INFIX
timeFrame: 6 months
measure: union
timeFrame: 1 yea
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
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.
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.
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.
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.