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Trial registered on ANZCTR


Registration number
ACTRN12624000320550
Ethics application status
Approved
Date submitted
12/02/2024
Date registered
25/03/2024
Date last updated
13/10/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the efficacy of Fibergraft Bioactive Glass in patients undergoing posterolateral lumbar fusion surgery
Scientific title
Radiological and clinical efficacy of Fibergraft Bioactive Glass in patients undergoing posterolateral lumbar fusion surgery
Secondary ID [1] 311519 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar degenerative disc disease 332863 0
Condition category
Condition code
Musculoskeletal 329579 329579 0 0
Other muscular and skeletal disorders
Surgery 329580 329580 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single-arm, prospective study that aims to assess the radiological and clinical efficacy of Fibergraft Bioactive Glass in patients undergoing posterolateral lumbar fusion surgery for degenerative disc disease. It is important to note that Fibergraft Bioactive Glass is commercially available within Australia, and has therefore been adopted into clinical practice as the primary bone graft substitute for this surgery. As such, if a patient chooses not to participate in the study, then neither their surgery or post-operative treatment will be effected in any way. If a patient does choose to participate, then they will be required to attend one non-standard follow up appointment at the 2-year (primary timepoint) post-operative timepoint.

The Procedure:
The surgery is performed whilst the patient is under general anaesthetic, and positioned lying prone on the operating bed. An incision (6-8cm) is made on the midline of the lower back, and the posterior musculature is dissected and retracted. Pedicle screws are inserted, and rods are placed. The transverse processes and facet joints of the vertebrae to be fused are decorticated and the shavings of local bone are left in place to act as autologous graft. Synthetic bone graft substitute is then overlayed in the posterolateral gutters. This may be performed in conjunction with a decompression via a laminectomy. This involves the removal of the lamina and decompression of the spinal nerves.

Fibergraft Bioactive Glass:
Fibergraft is a synthetic bone graft substitute designed to mimic the body's natural bone healing process and augment the use of autologous bone graft material. It is comprised of 45S5 bioactive glass and features a porous outer shell which allows for the uninterrupted growth of new bone through the cell.

The Follow-Up:
As a part of standard clinical practice, participants will be required to attend follow-up appointments at the 6-month, and 1-year post-operative timepoints. In addition to these appointments, participants will be required to attend one non-standard follow-up appointment at the 2-year post-operative timepoint, which represents the final timepoint within the observational period.

The Observations - radiological:
Participants will be required to undergo flexion/extension x-rays at the 6-month and 1-year post-operative timepoints. These images will be used to assess for screw breakage, rod breakage, and for angulation of greater than 5 degrees at the fused segment. At the 1- and 2-year post-operative timepoints, participants will be required to undergo a Computed Tomography (CT) scan which will be used to grade the degree of fusion at each segment, and assess for screw loosening, screw breakage, and rod breakage.

The Observations - patient reported outcomes:
At each of the post-operative appointments, participants will be asked to complete subjective questionnaires pertaining to their level of self reported pain and disability. These questionnaires include: the Oswestry Disability Index (ODI), and the Back and Leg Visual Analogue Scores (Back VAS and Leg VAS).
Intervention code [1] 327978 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337373 0
Posterolateral inter-transverse bone bridging
Timepoint [1] 337373 0
1- and 2-years post-operative
Primary outcome [2] 337374 0
Screw loosening
Timepoint [2] 337374 0
1- and 2-years post-operative
Primary outcome [3] 337375 0
Screw breakage
Timepoint [3] 337375 0
X-ray: 6- and 12-months post-operative
CT scan: 1- and 2-years post-operative
Secondary outcome [1] 431604 0
Rod breakage
Timepoint [1] 431604 0
X-ray: 6- and 12-months post-operative
CT scan: 1- and 2-years post-operative
Secondary outcome [2] 431605 0
Degree of angulation between the fused segments
Timepoint [2] 431605 0
6- and 12-months post-operative
Secondary outcome [3] 431606 0
Change in self reported disability
Timepoint [3] 431606 0
Baseline, and 8-weeks, 6-months, 1-year and 2-years post-operatively
Secondary outcome [4] 431607 0
Change in self reported pain
Timepoint [4] 431607 0
Baseline, and 8-weeks, 6-months, 1-year and 2-years post-operatively

Eligibility
Key inclusion criteria
1. Age greater than or equal to 18 at the time of surgery
2. Scheduled to undergo a one or two level PLF with a single surgeon at a private surgical practice
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Active workers compensation claim
2. Unable to participate in the required follow-up appointments
3. Ineligible to participate in the study as determined by the Principal Investigator

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study product (Fibergraft bioactive glass) was withdrawn from the Australian market. Not for efficacy concerns, but for business reasons.
Date of first participant enrolment
Anticipated
25/03/2024
Actual
23/05/2024
Date of last participant enrolment
Anticipated
2/02/2026
Actual
28/08/2024
Date of last data collection
Anticipated
29/11/2024
Actual
Sample size
Target
39
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26174 0
Brisbane Private Hospital - Brisbane
Recruitment postcode(s) [1] 42044 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 315810 0
Commercial sector/Industry
Name [1] 315810 0
Johnson & Johnson Medical Pty Ltd
Country [1] 315810 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
SpinePlus
Address
Country
Australia
Secondary sponsor category [1] 317938 0
None
Name [1] 317938 0
Address [1] 317938 0
Country [1] 317938 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314668 0
Brisbane Private Hospital Low Risk Ethics Review Committee
Ethics committee address [1] 314668 0
259 Wickham Terrace, Spring Hill, Queensland, 4000
Ethics committee country [1] 314668 0
Australia
Date submitted for ethics approval [1] 314668 0
30/11/2023
Approval date [1] 314668 0
21/12/2023
Ethics approval number [1] 314668 0

Summary
Brief summary
Instrumented posterolateral lumbar fusion surgery involves the fixation and posterolateral grafting of two or more adjacent lumbar vertebrae. Traditionally, local bone sourced from the patient’s hip has been viewed by surgeons as the gold standard for grafting material. However, studies have demonstrated that a significant number of patients report pain at the graft site for up to 6-month post-surgery. To mitigate this, medical device companies have developed synthetic bone graft substitutes which can be used in place of the patient’s local bone. One such material is Bioactive Glass, which is a synthetic bone graft substitute that is designed to mimic the body’s natural healing process. It achieves this role by promoting the growth of new bone cells, and acts as a scaffold that mimics natural bone and promotes cell attachment.

Due to the known benefits of synthetic bone graft substitutes, the Johnson & Johnson Medical Device Company have worked to develop FIBERGRAFT Bioactive Glass, which has previously been shown to be a safe and effective bone graft substitute in other procedures involving spinal fusion. The aim of this study is to gain a deeper understanding of the radiological and clinical effectiveness of FIBERGRAFT Bioactive Glass in patients undergoing instrumented posterolateral lumbar fusion surgery. The significance of this research lies with its practical application, in that our results will provide clinicians with the information they need in order to make more informed decisions regarding the selection of bone graft substitutes in this surgical procedure.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132342 0
A/Prof Paul Licina
Address 132342 0
SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland
Country 132342 0
Australia
Phone 132342 0
+61 413 427 048
Fax 132342 0
Email 132342 0
[email protected]
Contact person for public queries
Name 132343 0
Patrick Beaumont
Address 132343 0
SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland
Country 132343 0
Australia
Phone 132343 0
+61 413 427 048
Fax 132343 0
Email 132343 0
[email protected]
Contact person for scientific queries
Name 132344 0
Patrick Beaumont
Address 132344 0
SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland
Country 132344 0
Australia
Phone 132344 0
+61 413 427 048
Fax 132344 0
Email 132344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, all of the individual participant data will be shared.
When will data be available (start and end dates)?
Data will be available immediately following publication and for 5-years following publication.
Available to whom?
Data will be available after dissemination upon request and at the discretion of the sponsor. The data will only be distributed to researchers.
Available for what types of analyses?
Data will be available for primary and secondary analysis on the basis that the secondary analysis is related to the topic.
How or where can data be obtained?
Access is subject to approvals by the Principal Investigator.
Email: [email protected]
Contact number: 0413 427 048


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
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