FlexiCore® Intervertebral Disc Clinical Trial
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The [Institution] has been selected to participate in the FlexiCore® Intervertebral Disc Study.
FlexiCore® Intervertebral Disc
CAUTION: Investigational device. Limited by US law to investigational use.
The FlexiCore® Intervertebral Disc is indicated for the treatment of discogenic pain unresponsive to conservative treatment associated with degenerative disc disease (DDD). The FlexiCore® Intervertebral Disc is intended to replace a degenerated lumbar intervertebral disc (L1-S1), permit motion of the treated segment, improve function, and reduce back pain associated with DDD.
Study Summary
The study is a multi-center, prospective, randomized controlled clinical trial that will compare two surgical methods for treating lumbar back pain associated with DDD. Up to 25 investigational sites will participate in the study. All subjects will be randomized at a 2:1 ratio to receive either the investigational treatment or the control treatment (circumferential fusion), respectively. (For every 2 patients who receive treatment with the FlexiCore® Intervertebral Disc, 1 patient will receive the spinal fusion treatment.)
The purpose of the study is to compare the safety and effectiveness of the FlexiCore® Intervertebral Disc to circumferential spinal fusion surgery in the treatment of discogenic pain unresponsive to conservative treatment associated with DDD at a single level in the lumbosacral spine (L1-S1).
FlexiCore® Intervertebral Disc Study Inclusion Criteria and Exclusion Criteria
Inclusion Criteria
Patients must have the following conditions and meet the following inclusion criteria in order to be considered for enrollment in the study:
  1. Is skeletally mature and between 18 and 60 years of age, inclusively.
  2. Has DDD (back pain of discogenic origin with degeneration of the disc) at a single level between L1 and S1, confirmed by:
  3. Reporting of a greater percentage of back (axial) pain compared with the percentage of pain in either the left or the right leg (radicular) alone; and
  4. Either CT, MRI, myelography (within 6 months), or lateral flexion/extension films (within 3 months) demonstrating:
  5. Translational instability (≥ 3 mm translation), and/or
  6. Angular instability (≥ 5° angulation), and/or
  7. Decreased disc height (decreased >2 mm compared to adjacent (cranial) disc height).
  8. Records a pre-operative Visual Analog Scale (VAS) score for back pain of at least 40 on a 0-100 point scale.
  9. Records a pre-operative Oswestry Low Back Disability Questionnaire score of at least 40%. (This is interpreted as moderate/severe disability.)
  10. Has received non-operative treatment (change of activity and NSAIDS at a minimum) for back pain for a minimum of 6 months and is unresponsive.
  11. Agrees to comply with the protocol, including participating in long-term follow-up visits at the investigational site and completing study questionnaires.
  12. Can provide voluntary informed consent.
Exclusion criteria
Patients who have any of the following conditions or meet any of the following criteria may not participate in the study:
  1. Reports a greater percentage of pain in either the right or the left leg (radicular) alone compared with the percentage of back (axial) pain.
  2. Has symptomatic DDD at more than one lumbar level.
  3. Had any previous bilateral lumbar decompression or a unilateral decompression in which >50% of the ipsilateral facet has been removed, a microdiscectomy (if a facet fracture is suspected), or any lumbar fusion surgery (This is not intended to exclude IDET or closed laser disectomy).
  4. Has clinically compromised vertebral body structure at the affected level due to acute or past trauma, or significant endplate incompetence such as Schmorl's node or vertebral disc herniation.
  5. Has significant motion segment instability at the level to be treated or an adjacent level, defined as either:
  6. degenerative spondylolisthesis greater than 20% ('Grade 1'); or
  7. ≥4 mm translation (total excursion) on flexion/extension.
  8. Has spondylolysis or lytic (isthmic) spondylolisthesis at the level to be treated or an adjacent level.
  9. Has moderate to severe spinal stenosis at the level to be treated, or an adjacent level, requiring surgical decompression.
  10. Has lumbar scoliosis >10°.
  11. MRI or CT within the previous 6 months which confirms significant facet joint arthritic changes at the level to be treated or an adjacent level.
  12. Has previously diagnosed osteoporosis, Paget's disease, osteomalacia, or any other metabolic bone disease to a degree that spinal instrumentation would be contraindicated.
  13. Is taking medications known to potentially interfere with bone/soft tissue healing, e.g., long-term use of corticosteroids (This is not intended to exclude inhalation medications for asthma).
  14. Has an active infection — systemic or at the site of intended surgery.
  15. Has been diagnosed with rheumatoid arthritis, another autoimmune disease, active hepatitis, AIDS, or ARC, or is HIV positive.
  16. Has had a progressive neuromuscular disease or an active malignancy within the last 15 years, unless the malignancy was treated with curative intent and there have been no clinical signs or symptoms for at least 5 years.
  17. Has cervical myelopathy.
  18. Is morbidly obese, defined as a body mass index >40 or a weight more than 100 lbs. over ideal body weight.
  19. Is pregnant or interested in becoming pregnant in the next 3 years.
  20. Has a known allergy to cobalt, chromium, molybdenum, titanium, or stainless steel.
  21. Has had a surgical procedure involving general anesthesia or local/epidural anesthesia and an incision or any procedure that would increase risk of DVT within the last 30 days.
  22. Is currently participating in another investigational study for a similar purpose.
  23. Has a mental illness or belongs to a vulnerable population (e.g., is a prisoner or a severe drug abuser, or is developmentally disabled) such that his or her ability to provide informed consent or comply with follow-up requirements is compromised.