A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures

Not Applicable

Completed

• Conditions: Pelvic fracture; Injuries and Accidents - Fractures; Surgery - Surgical techniques

• Registration Number: ACTRN12616001421426
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

The indication for the use of INFIX was a fracture that the primary surgeon deemed as an unstable anterior ring fracture, typically with fracture site comminution

Exclusion Criteria

Patients were excluded in damage control situations with haemodynamic instability, open wounds, pubic diastasis injury, in paediatric and/or very low body mass index and the presence of hernias at the site surgical site

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measures was stability and fracture displacement at time of implant removal as a composite outcome measure. This was assessed by manual stress of the pelvic ring, after removal of the INFIX bar whilst the pedicle screws fixed in supra-acetabular bone were retained under anaesthesia) [Endpoint was at removal, which was a minimum of 3 months (mean time to removal of 109 days), but patient specific.]

Secondary Outcome Measures

Name	Time	Method
post-operative complications measured through clinical review, review of case notes and unit audit[From end of procedure until time of surgery for removal (minimum three months)];intra-operative complications measured through clinical review, review of case notes and unit audit[At time of surgery and on immediate follow up of patient when they remained an inpatient]