Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000197336
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
6/02/2017
Date last updated
22/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Microbiology of the pars interarticularis in patients undergoing lumbar fusion surgery for chronic back pain and isthmic spondylolisthesis.
Scientific title
Microbiology of the pars interarticularis in patients undergoing lumbar fusion surgery for chronic back pain and isthmic spondylolisthesis.
Secondary ID [1] 290909 0
Nil Known
Universal Trial Number (UTN)
U1111-1191-5260
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Back Pain 301627 0
Isthmic Spondylolisthesis 301628 0
Low-grade infections 301629 0
Condition category
Condition code
Musculoskeletal 301333 301333 0 0
Other muscular and skeletal disorders
Infection 301334 301334 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective investigation of patients from the Princess Alexandra Hospital Orthopaedic outpatients, undergoing conventional surgical management (lumbar fusion surgery) for chronic low back pain associated with isthmic spondylolithesis and corresponding pars defect. Samples of bilateral pars defects, ligamentum flavum, intervertebral disc, and para-spinal muscle tissue will be collected; tissue normally discarded during your lumbar fusion surgery. These samples will then be sent for microbiological analysis. Approximately 50 patients will be recruited over 2 years.
Intervention code [1] 296862 0
Not applicable
Comparator / control treatment
Tissues samples from the ligamentum flavum, paraspinal muscles and intervertabral disc will act as control/comparator samples to exclude contamination in the study.
Control group
Active

Outcomes
Primary outcome [1] 300750 0
Proportion of patients with subacute infection identified at the pars defect
Timepoint [1] 300750 0
At completion of study and statistical analysis of results
Secondary outcome [1] 330781 0
Proportion of control samples with positive culture results
Timepoint [1] 330781 0
At completion of study and statistical analysis of results

Eligibility
Key inclusion criteria
Patient age > 18 years
Radiologically confirmed isthmic spondylolisthesis
Planed for lumbar spinal fusion surgery

Patients of specific staff specialists, seen at the Princess Alexandra Hospital Orthopaedic Outpatient Department Spine Clinics.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years
Previous lumbar spinal surgery

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will performed at the completion of the study to evaluate the data collected (including regression analysis, Chi-squared and T-tests). Participant numbers are based on the sample size required to conduct appropriate statistical analysis while taking into account external constraints of participant availability in a public hospital. In study analysis will also be performed during the study to determine if the participant numbers are sufficient to calculate significance or a larger sample size is needed. Variables such as previous steroid injections, age, gender and other medical conditions will also be considered in correlation analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/02/2017
Actual
11/05/2017
Date of last participant enrolment
Anticipated
2/11/2019
Actual
Date of last data collection
Anticipated
11/11/2019
Actual
Sample size
Target
50
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 7316 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 15091 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 295341 0
Commercial sector/Industry
Name [1] 295341 0
Prism Surgical Designs Pty Ltd (Financial funder)
Country [1] 295341 0
Australia
Primary sponsor type
Hospital
Name
The Princess Alexandra Hospital Orthopaedic Department - Dr Kathleen Capehart & Dr Dihan Aponso (Principal Investigators)
Address
199 Ipswich Rd Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 294166 0
None
Name [1] 294166 0
NONE
Address [1] 294166 0
None
Country [1] 294166 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296677 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 296677 0
Metro South Human Research Ethics Committee, Centres for Health Research
Princess Alexandra Hospital, Metro South Health

Metro South Hospital and Health Service, Queensland Government
Level 7 TRI, 37 Kent Street WOOLLOONGABBA QLD 4102
Ethics committee country [1] 296677 0
Australia
Date submitted for ethics approval [1] 296677 0
04/11/2016
Approval date [1] 296677 0
11/11/2016
Ethics approval number [1] 296677 0
HREC/16/QPAH/501 - SSA/16/QPAH/502

Summary
Brief summary
This study aims to investigate whether an underlying subacute infection at the pars defect is a possible cause of pain in patients requiring lumbar spinal fusion surgery. The study will perform microbiological analysis of the bone, ligamentous, muscle and disc tissue at/adjacent to the pars defect, taken from normally discarded material intraoperatively. The presence of infection will be determined by positive bacterial culture from these sites and results analysed for statistical significance. Detection of bacteria would support an infectious rationale, as a source of back pain, in this population. This research endeavors to clarify the source of back pain in isthmic spondylolithesis patients the search for suitable, reliable and reproducible conservative treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71662 0
Dr Kathleen Capehart
Address 71662 0
The Princess Alexandra Hospital, Orthopaedic Department, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 71662 0
Australia
Phone 71662 0
+61439761195
Fax 71662 0
Email 71662 0
[email protected]
Contact person for public queries
Name 71663 0
Dr Kathleen Capehart
Address 71663 0
The Princess Alexandra Hospital, Orthopaedic Department, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 71663 0
Australia
Phone 71663 0
+61439761195
Fax 71663 0
Email 71663 0
[email protected]
Contact person for scientific queries
Name 71664 0
Dr Kathleen Capehart
Address 71664 0
The Princess Alexandra Hospital, Orthopaedic Department, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 71664 0
Australia
Phone 71664 0
+61439761195
Fax 71664 0
Email 71664 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.