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.

Not Applicable

Completed

• Conditions: Degenerative Disc Diease; Intervertebral Disc Disease; Non-specific Degenerative Disease of the lumbar spine; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619001145190
• Lead Sponsor: Mobius Medical Pty Ltd

Brief Summary

Research Question To evaluate the safety, tolerability and efficacy of DiscSeal in the treatment of low back pain for patients with Discogenic Disease of the lumbar spine. Background Two sites in Australia recruited participants with chronic low back pain who had failed first line therapy and had at least moderate disability and chronic low back pain. Participant characteristics 10 participants were consented to the study. 4 failed eligibility screening and 6 had the index procedure. The mean age was 38.8 years of age and 5/6 participants were male, Caucasian. The mean height, weight and BMI was 174.3cm, 17.7kg and 28.2 respectively. Results There were two serious adverse events reported that were judged by the independent medical monitor as unrelated to the study device and procedure. The following efficacy results are reported as a change from baseline at 90 and 180 days respectively. Low back pain reduced by 27% and then 42%. Leg pain reduced by 47% and then 37%. Oswestry Disability Index (ODI) scores reduced by 22% and then 14%. Overall Health Status (OHS) improved by 55% and 68%. The evaluation of the Per Protocol Analysis (n=5) reflected that low back pain outcomes were reduced by 32% and 45%, leg pain reduced by 56% and 38%, ODI reduced by 40% and 27% and OHS improved by 78% and 86%. Limitations As the study was first in human, treatment was limited to a single disc when 5/6 participants had multi-disc disease.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-16
• Study Completion: 2020-08-14
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified