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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lumbar degenerative disc disease

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Surgery

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]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Posterolateral inter-transverse bone bridging

Assessment method [1]

Computed Tomography (CT) scan will be assessed by two independent radiologists who will define fusion using a pre-determined criteria: Grade 1 - no fusion Grade 2 - partial of limited unilateral fusion Grade 3 - partial or limited bilateral fusion Grade 4 - Solid unilateral fusion Grade 5 - solid bilateral fusion

Timepoint [1]

1- and 2-years post-operative

Primary outcome [2]

Screw loosening

Assessment method [2]

CT scan

Timepoint [2]

1- and 2-years post-operative

Primary outcome [3]

Screw breakage

Assessment method [3]

X-ray and CT scan

Timepoint [3]

X-ray: 6- and 12-months post-operative CT scan: 1- and 2-years post-operative

Secondary outcome [1]

Rod breakage

Assessment method [1]

X-ray and CT scan

Timepoint [1]

X-ray: 6- and 12-months post-operative CT scan: 1- and 2-years post-operative

Secondary outcome [2]

Degree of angulation between the fused segments

Assessment method [2]

Flexion extension x-ray imaging

Timepoint [2]

6- and 12-months post-operative

Secondary outcome [3]

Change in self reported disability

Assessment method [3]

Oswestry Disability Index

Timepoint [3]

Baseline, and 8-weeks, 6-months, 1-year and 2-years post-operatively

Secondary outcome [4]

Change in self reported pain

Assessment method [4]

Back and leg visual analogue scale (VAS)

Timepoint [4]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Brisbane Private Hospital - Brisbane

Recruitment postcode(s) [1]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Johnson & Johnson Medical Pty Ltd

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

SpinePlus

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Brisbane Private Hospital Low Risk Ethics Review Committee

Ethics committee address [1]

259 Wickham Terrace, Spring Hill, Queensland, 4000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/11/2023

Approval date [1]

21/12/2023

Ethics approval number [1]

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

Public notes

Contacts

Principal investigator

Name

A/Prof Paul Licina

Address

SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland

Country

Australia

Phone

+61 413 427 048

research@spineplus.com.au

Contact person for public queries

Name

Patrick Beaumont

Address

SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland

Country

Australia

Phone

+61 413 427 048

patrick@spineplus.com.au

Contact person for scientific queries

Name

Patrick Beaumont

Address

SpinePlus | Level 7, 259 Wickham Terrace, Spring Hill, 4000, Queensland

Country

Australia

Phone

+61 413 427 048

patrick@spineplus.com.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Data will be available after dissemination upon request and at the discretion of the sponsor. The data will only be distributed to researchers.

Conditions for requesting access:
• -

What individual participant data might be shared?

• After de-identification, all of the individual participant data will be shared.

What types of analyses could be done with individual participant data?

• Data will be available for primary and secondary analysis on the basis that the secondary analysis is related to the topic.

When can requests for individual participant data be made (start and end dates)?

From:
Data will be available immediately following publication and for 5-years following publication.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Access is subject to approvals by the Principal Investigator.
Email: research@spineplus.com.au
Contact number: 0413 427 048

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically