None listed
Conditions
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
Interventions
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 wi
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.
Sponsors
Mobius Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed