Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001421426
Ethics application status
Approved
Date submitted
30/09/2016
Date registered
12/10/2016
Date last updated
12/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective case series for a minimally invasive internal fixation device for anterior pelvic ring fractures
Scientific title
A prospective case series for a minimally invasive internal fixation device (INFIX) for anterior pelvic ring fractures: measuring stability and fracture displacement
Secondary ID [1] 290247 0
None
Universal Trial Number (UTN)
U1111-1188-1643
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic fracture 300455 0
Condition category
Condition code
Injuries and Accidents 300316 300316 0 0
Fractures
Surgery 300416 300416 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single centre prospective case series at a single Level 1 Trauma Centre was performed from February 2013 until July 2014. The indication for the use of INFIX (two pedicle screws inserted into supraacetabular bone connected by a cobalt chrome bar subcutaneously) was a fracture that the primary surgeon deemed as an unstable anterior ring fracture, typically with fracture site comminution. Fractures were classified using the Young-Burgess classification. . The INFIX was not used for fixation of pubic symphysis injury. The case series was commenced after a 10 patient learning curve by the primary surgeon. Participants were excluded if there was not a minimum six-month follow up. The primary outcome measures were stability and fracture displacement at time of implant removal (assessed by manual stress of the pelvic ring under anaesthesia) and intra and post-operative complications. Data were collected from the Royal Melbourne Hospital Trauma Registry. Descriptive statistics were used to analyse results.

Surgical technique
If required, stability of the posterior pelvic ring was achieved prior to application of the INFIX. For application of the INFIX a 3cm vertical or oblique incision was made lateral to the interval between Sartorius and Tensor Fascia Lata (TFL), as per the Smith Petersen or anterior approach to the hip joint. The fascia of TFL was incised and blunt dissection continued to the anterior inferior iliac spine (AIIS) between the belly of TFL and Sartorius, reflecting the fascia medially with Sartorius to protect the Lateral Femoral Cutaneous Nerve (LFCN). A 4.3mm drill was used to open the bony safe corridor for the screws, with an entry point at the AIIS, using fluoroscopy to confirm accurate placement on Judet views of the iliac wing. The drills were exchange for guide wires and the corridors tapped to 9 mm over the guide wire. Cannulated Pedicle screws (DePuy SAI Viper, Warsaw, Indiana) (10mm x 100mm) were inserted, also over the guide wires. Screw position was confirmed with fluoroscopy. The screw head was made to sit such that the connecting bar was subcutaneous and superficial to the fascia of the abdominal wall. A 5.5mm Cobalt Chromium bar was contoured then placed subcutaneously. The rod was connected to the screw heads and locked at one end. Reduction of the anterior pelvic ring injury was achieved by compression or distraction of the rod prior to locking of the remaining screw head.
Intervention code [1] 296033 0
Treatment: Surgery
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299783 0
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)
Timepoint [1] 299783 0
Endpoint was at removal, which was a minimum of 3 months (mean time to removal of 109 days), but patient specific.
Secondary outcome [1] 328105 0
post-operative complications measured through clinical review, review of case notes and unit audit
Timepoint [1] 328105 0
From end of procedure until time of surgery for removal (minimum three months)
Secondary outcome [2] 328326 0
intra-operative complications measured through clinical review, review of case notes and unit audit
Timepoint [2] 328326 0
At time of surgery and on immediate follow up of patient when they remained an inpatient

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective case series
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Basic descriptive statistics

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
31/07/2014
Date of last data collection
Anticipated
Actual
30/09/2015
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 294614 0
Self funded/Unfunded
Name [1] 294614 0
Self funded
Country [1] 294614 0
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Royal Melbourne Hospital
Department of orthopaedics
300 Grattan St,
Parkville VIC 3050
Australia
Country
Australia
Secondary sponsor category [1] 293477 0
None
Name [1] 293477 0
None
Address [1] 293477 0
None
Country [1] 293477 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296058 0
Royal Melbourne Hospital Human Research and Ethics Committee
Ethics committee address [1] 296058 0
Ethics committee country [1] 296058 0
Australia
Date submitted for ethics approval [1] 296058 0
01/08/2014
Approval date [1] 296058 0
05/08/2014
Ethics approval number [1] 296058 0
QA2013003

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69382 0
Dr Wayne Hoskins
Address 69382 0
University of Melbourne
Grattan St
Parkville VIC 3052
Country 69382 0
Australia
Phone 69382 0
+61425253907
Fax 69382 0
Email 69382 0
[email protected]
Contact person for public queries
Name 69383 0
Wayne Hoskins
Address 69383 0
University of Melbourne
Grattan St
Parkville VIC 3052
Country 69383 0
Australia
Phone 69383 0
+61425253907
Fax 69383 0
Email 69383 0
[email protected]
Contact person for scientific queries
Name 69384 0
Wayne Hoskins
Address 69384 0
University of Melbourne
Grattan St
Parkville VIC 3052
Country 69384 0
Australia
Phone 69384 0
+61425253907
Fax 69384 0
Email 69384 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.