None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and clinical effectiveness of the Intralink medical device when treating low back pain due to Degenerative Disc Disease in adults. Degenerative disc disease in the lower back refers to a syndrome in which a compromised or damaged disc causes low back pain with or without pain radiating to the leg. Intralink is an injectable soluble polymeric material that is considered as a medical device. Intralink covalently bonds with the collagen in the spinal disc tissue to structurally strengthen the degraded disc and stabilize the spinal joint. These tissue strengthening and joint stabilizing effects, if they occur to the extent intended, may reduce the amount of back pain that the study participant experiences. Intralink contains a substance called Genipin that forms a mesh of load-sharing polymers that bond to the collagen matrix in load supporting tissues. Genipin is made from purified plant sources (Gardenia fruit) and is dissolved in a special buffer liquid prior to being injected into the spinal disc using image-guided injection techniques. A special dye called a contrast agent that is not part of Intralink is also added to Intralink before it is injected so that what is being injected can be seen by the physician doing the injection. There are two primary hypotheses being tested in this study. The first hypothesis involves the safety of the device and its image-guided delivery to the study participant. It is hypothesized that Intralink can be safely applied to degenerated intervertebral discs as evidenced by a clinically acceptable prevalence of Serious Adverse Events reported at 1 month post-procedure. The second primary hypothesis involves the clinical effectiveness of the device. It is hypothesized that the clinical success rate at 3 months after the Intralink implantation procedure will be greater than or equal to 50%. Clinical success is defined as successful injection delivery of Intralink to the targeted disc without the occurrence of serious adverse events with a significant reduction of pain and disability using standard assessment metrics. Objective imaging data will also be used to validate reduction of pain post-treatment. A maximum of 50 participants will be enrolled in this clinical study at 2-5 clinical centers. Safety and clinical effectiveness assessments will be carried out through 12 months post-implantation procedure.
Interventions
Intervention Type- Device,
Intervention Name - Intralink (previously IDSD),
Intervention Description - Intralink is an injectable medical device intended to treat intervertebral disc degeneration and associated low back pain by providing localized tissue reinforcement and mechanical stabilization. The Intralink medical device is injected directly into the disc annulus fibrosus tissue. Intralink contains a plant derived self-polymerizing protein-bonding molecule (Genipin) that is injected after d
Intervention Type- Device, Intervention Name - Intralink (previously IDSD), Intervention Description - Intralink is an injectable medical device intended to treat intervertebral disc degeneration and associated low back pain by providing localized tissue reinforcement and mechanical stabilization. The Intralink medical device is injected directly into the disc annulus fibrosus tissue. Intralink contains a plant derived self-polymerizing protein-bonding molecule (Genipin) that is injected after dissolving in a buffered liquid carrier combined with a contrast agent by a clinician experienced with image-guided injections to the spinal disc. The choice of contrast agent is left to the investigator. 180-370 mg/ml Isovue, Omnipaque, Iopamiro, and Ultravist have been previously tested. The clinician is provided with an injection training document, a virtual training session, detailed instructions for use, and optional cadaveric injection training. Intralink is a single-use device comprising two 5 mL glass vials containing the sterile cross-linker and buffered carrier solution. The components are combined with a contrast agent just prior to the fluoroscopic image-guided interventional procedure. The genipin forms polymers as it diffuses through the tissue and adds a mesh of these polymers to the native collagen matrix in the disc, forming covalent bonds between the ends of the genipin polymers and the native disc collagen. The increased mechanical support to the tissue and intervertebral joint are intended to add load support to the collagen matrix and reduce or eliminate aberrant motions and deformations corresponding to low back pain. All study participants will undergo implantation of Intralink at 1 or 2 symptomatic spinal levels during a single intervention session. High mechanical demand participants may receive a second implantation of Intralink in a separate intervention session. The volume of Intralink implanted is determined by the cross-sectional size of the target disc(s). The procedure takes approximately 45 minutes or less.
Sponsors
Intralink-Spine Australia 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 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adults 18-60 years old 2. Degenerative Disc Disease at 1 or 2 levels between L2 and S1, with clinical presentation of discogenic pain where the central back pain is greater than radicular pain (leg, hips, or buttocks), confirmed by: a. MRI correlative to the affected segment, and/or b. discography with concordant pain within 6 months- If imaging and examination can not conclusively determine which disc is the source of the pain, a discogram is mandated for confirmation. 3. Failed non-operative treatment which may include injections or radiofrequency denervation of medial lumbar and lateral sacral branches (failed response is considered when pain relief lasted less than or equal to 3 months) 4. Preoperative Numeric Rating Scale (NRS) score for back pain greater than or equal to 4 or Visual Analog Score for back pain greater than or equal to 40 mm. 5. Preoperative Oswestry Disability Index (ODI) score greater than or equal to 30% 6. Documented symptoms for a cumulative minimum of 3 months 7. Participant is competent to sign the informed consent 8. Participant voluntarily signs the participant informed consent form and agrees to the release of medical information for purposes of this study
Exclusion criteria
1. Symptomatic DDD at more than 2 levels 2. Less than 3 months of back pain 3. Previous diagnosed Paget's disease, osteomalacia, other metabolic bone disease or insulin-dependent diabetes 4. Evidence of spinal osteopenia or osteoporosis (radiographic or DEXA) 5. Active systemic or spine infection 6. Previous device or therapeutic interventions on the target disc (excluding those listed in the Inclusion Criteria) 7. Any surgery at the index level and any extensive surgery (fusion, laminectomy, artificial disc) at any level 8. Chronic steroid use (except for inhaled steroids) 9. Other diagnosed causes of back pain or neuropathy such as vertebral fracture, facet joint or vertebral arch (spondylolysis) generated pain, rheumatoid arthritis, cauda equine syndrome, spinal fracture within last 6 months, and sacroiliac joint pain 10. Previous treatment of target disc level with steroid injection in past 3 months 11. Active malignancy 12. Spinal tumor 13. Immune compromised participants 14. Lumbar scoliosis > 15 degrees 15. Evidence of disc herniation or large penetrating fissure including current diagnosis of sciatica, disc bulge > 5mm with radicular pain, or abnormal neurological examination (excluding diminished pin prick test), or in the case of previous sciatica (not current) presence of penetrating disc tear confirmed by observation of Dallas 5 disc tear (Dallas Discogram Classification System) during (mandatory) pressure-controlled discography using an automated injection device. 16. Symptomatic spinal stenosis 17. Congenital or degenerative spondylolisthesis (grade 2 and 3) 18. Psychological comorbidities that could contribute to the need for seeking medical treatment (e.g., depression, anxiety,cPTSD, borderline PD, schizophrenia, substance abuse) 19. Anticipated compliance problems (e.g., transportation, dementia, computercilliteracy) 20. Currently participating in another investigational study that could interfere with the outcome measurements of this study 21. Known anaphylactic reaction to contrast dye 22. Opioid daily intake > 90 MEQ 23. Not able to communicate with study center staff sufficiently to complete study questionnaires 24. Positive urine pregnancy test 25. History of unexplained, easy or persistent bruising or bleeding, bleeding from the gums, or bleeding problems experienced in previous surgical procedures 26. Congenital or acquired coagulopathy or thrombocytopenia; or currently taking anticoagulant, antineoplastic, antiplatelet, or thrombocytopenia-inducing medications, or undergoing radiation therapy 27. Annular rim tear suspected by posterolateral located high intensity zone or a focal disc protrusion on MRI, confirmed by observation of Dallas 5 disc tear (Dallas Discogram Classification System) during (mandatory) pressure-controlled discography using an automated injection device.
Outcome results
None listed