Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001145190
Ethics application status
Approved
Date submitted
17/07/2019
Date registered
16/08/2019
Date last updated
18/06/2021
Date data sharing statement initially provided
16/08/2019
Date results information initially provided
10/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study to evaluate the safety of the DiscSeal device in the treatment of lower back pain for patients with Discogenic Disease (including Degenerative Disc Disease (DDD), Intervertebral Disc Disease (IDD), and/or non-specific discogenic disease) of the lumbar spine.
Scientific title
A Prospective, Single-Arm Feasibility Clinical Study To Investigate The Safety, Tolerability and Exploratory Efficacy Of DiscSeal For The Treatment Of Degenerative And Diseased Intervertebral Disc (IVD) Of The Lumbar Spine
Secondary ID [1] 298715 0
Nil known
Universal Trial Number (UTN)
U1111-1236-8744
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Degenerative Disc Diease 313621 0
Intervertebral Disc Disease 313622 0
Non-specific Degenerative Disease of the lumbar spine 313623 0
Condition category
Condition code
Musculoskeletal 312054 312054 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: DiscSeal, a propriety product developed using poly methyl methacrylate (PMMA) microspheres and sodium hyaluronate (HA) is injected into the nucleus pulposus using modified discography under live fluoroscopic guidance, to alleviate lower back pain for people who have failed first line therapy.
This is a day procedure where participants will lie on their side to have discography. They will be given a local anesthetic at the injection site (lower back). It is expected the procedure will not take more than an hour. The participant will be able to walk out of the hospital shortly after the procedure. Up to two injections can be given per intervertebral disc with up to two intervertebral discs treated.
DiscSeal is injected by qualified physicians (mostly pain specialists) who have experience conducting discographies.
Participants will be screened in detail using medical notes. The study staff will document all study related visits and extensively document the treatment procedure.
Intervention code [1] 314974 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320685 0
peri-treatment device related serious adverse events
Adverse events that are known with discography include: swelling at the injection site, bruising at the injection site, allergic reaction to local anaesthesia or contrast material, nausea, injury to blood vessels or nerves in and around the spine, bleeding, temporary numbness or weakness, nerve damage, paralysis, infection at the injection site, headache, increased localised pain at the injection site, a vascular reaction on the skin (Urtcaria), bleeding under the skin (retroperitoneal haemorrhage), and potential worsening of back pain.
Additional potential adverse events associated with DiscSeal include, allergic reaction to the components of DiscSeal which may lead to a severe reaction (anaphylactic shock), insufficient contrast agent injected requiring a repeat of the procedure, injection into the epidural region potentially leading to nerve root compression, extravasation of material into the epidural space potentially leading to nerve root compression, air bubbles introduced by surgeon potentially leading to decreased efficacy..
Adverse events will be self-reported as well as through a brief physical exam at all study visits (except the treatment visit).
Adverse events will be assessed by an independent medical monitor.
Timepoint [1] 320685 0
peri-treatment device related serious adverse events will be recorded at visit 2 (treatment day 1) which is when the procedure is performed and the device implanted.
Primary outcome [2] 320686 0
post-treatment device related serious adverse events.
Known post-treatment device related serious adverse events include transient localised pain relating to the implant.
Adverse events will be self-reported as well as through a brief physical exam at all study visits (except the treatment visit).
Adverse events will be assessed by an independent medical monitor.
Timepoint [2] 320686 0
Adverse events will be collected from visit two (treatment and day 1) onwards. Adverse events will be assessed at day 7, day 42, day 90 and day 180 (end of study).
Secondary outcome [1] 372483 0
Change in lower back pain averaged over the last 24hrs as assessed with the Visual Analogue Scale
Timepoint [1] 372483 0
90 days and 180 days post treatment
Secondary outcome [2] 372484 0
Change in function due to a change in lower leg or back pain measured using the Oswestry Disability Index Questionnaire.
Timepoint [2] 372484 0
90 and 180 days post treatment
Secondary outcome [3] 372485 0
A change in illness assessed using the Clinical Global Impression of Change Questionnaire as completed by the treating doctor.
Timepoint [3] 372485 0
90 and 180 days post treatment
Secondary outcome [4] 372486 0
A change in the patient's belief of overall status assessed using the Patient Global Impression of Change Questionnaire.
Timepoint [4] 372486 0
90 and 180 days post treatment
Secondary outcome [5] 372487 0
Change in Patient Rating of Overall Health Status Questionnaire
Timepoint [5] 372487 0
90 and 180 days post treatment
Secondary outcome [6] 373805 0
Change in leg pain averaged over the last 24hrs as assessed with the Visual Analogue Scale
Timepoint [6] 373805 0
90 days and 180 days post treatment

Eligibility
Key inclusion criteria
1. Male or female between the ages of 18 and 70 years (inclusive); if female, must have a negative pregnancy test at the time of treatment, be actively practicing contraception or abstinence, be surgically sterilized, or be postmenopausal.
2. Participant presently has degenerative disc disease, as evidenced by:
I. History and clinical findings suggestive of degenerative disc disease (DDD), internal disc disruption (IDD) or non-specific discogenic disease and
II. At least Modic Type 1 changes on MRI, and
III. Disc height greater than or equal to 50% of normal disc height (defined as average height of adjacent normal discs) based on anteroposterior and lateral lumbar spine radiographs (plain X-ray images)
3. Experiencing back pain
4. Oswestry Disability Index (ODI) greater than 21% (i.e., at least moderate disability)
5. At least one lumbar disc with Pfirrmann Grade II-IV or Modic Type 1-2 changes without annular rupture.
6. No annular tears present in the disc(s) planned for treatment which reaches the distal periphery of the annulus with the potential for being incapable of holding the Discseal in situ
7. Tried and failed at least 6 weeks of conservative management as directed by a licensed physician, chiropractor, and/or physical therapist. Treatment must include any or a combination of physical therapy, chiropractic care, or pain management, including but not limited to, rest or activating physical therapy, heat, cold, electrical stimulation, ultrasound, manipulation, acupuncture, analgesics including narcotics (with no history of abuse), anti-inflammatory medication, radiofrequency treatments, and spinal injections, including epidural steroid, facet joint injection and or anesthesia injections
8. Participants who are legally competent and able to understand the nature, scope and aim of the clinical investigation.
9. Participant is on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 30 days prior to baseline evaluation
10. Participant is willing to remain on the current medication regimen for the next 90 days following the investigational procedure
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body mass index (BMI) greater than or equal to 40 kg/m2 at the Screening Visit.
2. Disc height of <50% of normal disc height (defined as average height of adjacent normal discs) based on anteroposterior and lateral lumbar spine radiographs (plain X-ray images)
3. More than one Pfirrmann Grade III or IV lumber disc
4. Pfirrmann Grade V lumbar disc at any level in the lumbar spine
5. Current disc extrusion at any level in the lumbar spine unsuitable for treatment in the opinion of the investigator
6. Disc bulges or protrusions at any level in the lumbar spine resulting in radiculopathy
7. Osteoporotic compression fracture at any vertebral level
8. Lumbar Scheurmann disease or other significant wedge deformity or malalignment at the targeted level
9. Anterolisthesis or retrolisthesis greater than or equal to 3 mm at any level
10. Moderate to severe facet disease at any level of the lumbar spine, at the investigator’s discretion
11. Symptomatic central canal stenosis or symptomatic foraminal stenosis
12. Spondylolysis or instability at any level
13. Lumbar coronal angulation greater than or equal to 10°
14. Cauda equina syndrome
15. Extradiscal extravasation of contrast on discogram
16. Participants who cannot tolerate modified discography
17. Previous spine surgery or other invasive treatment of the study disc, with the exception of previous epidural steroid or anaesthesia injection
18. Currently experiencing chronic pain generating from any other source that (in the judgment of the investigator) may interfere with the evaluation of back pain, and or back pain related disability and/or physical well being
19. Radicular pain >50% of low back pain (as evidenced by nerve root tension signs) and/or radiculopathy or participants that have primary radicular pain due to nerve compression
20. Scoliosis
21. Active systemic infection or infection at the operative site, as
evidenced by a brief physical examination
22. Suffers from rheumatoid arthritis or other autoimmune disease or a
systemic disorder such as HIV, active hepatitis B or C or fibromyalgia
23. Has a medical condition (e.g., unstable cardiac disease, cancer) that
may result in participant death or have an effect on outcomes prior to
study completion
24. Has a physical or mental condition that may confound the findings of the study
25. Incarcerated at the time of study enrollment
26. Has been enrolled in a clinical investigation for the treatment of
intervertebral disc disease, or received a study drug or investigational
biological agent for the treatment of intervertebral disc disease within
the last 180 Days
27. Has been enrolled in any other clinical investigation in the past 90
Days, is currently enrolled in any other clinical investigation or is
planning to be enrolled in any other clinical investigation during the
complete study period
28. Any known allergy to contrast agent
29. Pregnancy
30. Opioid use greater than the allowed amount for a period longer than deemed acceptable by the trial sponsor.
31. Unwilling or incapable of discontinuing any of the medications listed
in the prohibited medication list
32. Any known allergy to sodium hyaluronate or polymethyl methacrylate

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No formal sample size calculation has been performed, and the sample size is empirical. However, the sample size of up to 10 participants is considered sufficient to adequately characterize the general safety profile of this type of device study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/08/2019
Actual
24/10/2019
Date of last participant enrolment
Anticipated
28/10/2019
Actual
22/01/2020
Date of last data collection
Anticipated
28/04/2020
Actual
14/08/2020
Sample size
Target
10
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 14212 0
Metro Pain Group - Clayton
Recruitment hospital [2] 14214 0
Sydney Spine and Pain Specialists - Hurstville
Recruitment postcode(s) [1] 27202 0
2220 - Hurstville
Recruitment postcode(s) [2] 27195 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 303267 0
Commercial sector/Industry
Name [1] 303267 0
SpineOvations Inc.
Country [1] 303267 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Mobius Medical Pty Ltd
Address
Suite 401
275 Alfred St
North Sydney NSW 2060
Australia
Country
Australia
Secondary sponsor category [1] 303277 0
None
Name [1] 303277 0
Address [1] 303277 0
Country [1] 303277 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303806 0
Bellberry
Ethics committee address [1] 303806 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 303806 0
Australia
Date submitted for ethics approval [1] 303806 0
17/07/2019
Approval date [1] 303806 0
30/09/2019
Ethics approval number [1] 303806 0
2019-07-595

Summary
Brief summary
The primary objective of this study is to evaluate safety of the DiscSeal device in the treatment of lower back pain for patients with Discogenic Disease (including Degenertative Disc Disease (DDD), Intervertebral Disc Disease (IDD), and/or non specific discogenic disease) of the lumbar spine. It is hoped that the device will alleviate pain and delay more aggressive surgical interventions
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94874 0
Dr James Yu
Address 94874 0
Australian Medical Research
Suite 706
31 Dora St
Hurstville NSW 2220
Country 94874 0
Australia
Phone 94874 0
+61 2 9580 3380
Fax 94874 0
+61 2 9580 3370
Email 94874 0
contact@sydneyspinepain.com
Contact person for public queries
Name 94875 0
Mr Lachlan Porter
Address 94875 0
Mobius Medical
Suite 401
275 Alfred St
North Sydney NSW 2060
Country 94875 0
Australia
Phone 94875 0
+61 2 8317 5460
Fax 94875 0
+61 2 8317 5461
Email 94875 0
lachlan@mobiusmedical.com.au
Contact person for scientific queries
Name 94876 0
Mr Lachlan Porter
Address 94876 0
Mobius Medical
Suite 401
275 Alfred St
North Sydney NSW 2060
Country 94876 0
Australia
Phone 94876 0
+61 2 8317 5460
Fax 94876 0
+61 2 8317 5461
Email 94876 0
lachlan@mobiusmedical.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As a first in human study, with a small sample size, analysis of the preliminary safety and efficacy data will be conducted internally only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Research Question To evaluate the safety, tolera... [More Details]

Documents added automatically
No additional documents have been identified.