FlexiCore™ Intervertebral Disc Clinical Trial

Approximately 25 centers will be participating in the study. The control treatment is spinal fusion. Treatment assignment is randomized using a 2 to 1 ratio. For every 2 patients who receive treatment with the FlexiCore™ Intervertebral Disc, 1 patient will receive the spinal fusion treatment.

Inclusion criteria
Patients must have the following conditions and meet the following inclusion criteria in order to be considered for enrollment in the study:

• Degenerative disc disease, confirmed by clinical symptoms of back pain of discogenic origin and radiographic signs of degeneration of the disc (x-rays, CT, or MRI), at a single level in the lumbo-sacral spine (L1-S1)
• Back pain is greater than pain in either right or left leg alone
• Pre-op pain score ≥40 (Visual Analog Scale)
• Pre-op low back disability score ≥40 (Oswestry)
• Skeletally mature and between the ages of 18 to 60, inclusively
• Unresponsive to a minimum of 6 months of conservative (non-surgical) treatment for back pain
• Mentally and physically able to fully comply with the study plan, including participating in long-term follow-up visits at the study site and completing study questionnaires
• Able to understand and sign a voluntary written 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:

• Right or left leg pain greater than back pain
• Symptomatic degenerative disc disease at more than one lumbar level
• Prior bilateral open lumbar decompressive procedure, microdiscectomy (if facet fracture is suspected), any lumbar fusion surgery. IDET or closed laser discectomy is not, alone, grounds for exclusion
• 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
• Significant motion instability at the level to be treated
• Spondylolysis or lytic spondylolisthesis at the level to be treated, or an adjacent level, requiring surgical decompression
• Lumbar scoliosis >10 degrees
• Significant facet joint arthritic changes at the level to be treated or an adjacent level, confirmed by CT or MRI
• Previously diagnosed osteoporosis, Paget’s disease, osteomalacia, or any other metabolic bone disease to a degree that spinal instrumentation would be contraindicated
• Taking drugs known to potentially interfere with bone/soft tissue healing
• Active infection, systemic or at the site of intended surgery
• Rheumatoid arthritis, hepatitis, AIDS, ARC, HIV positive, or other autoimmune diseases
• Progressive neuromuscular disease or 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
• Cervical myelopathy
• Morbid obesity, defined as BMI >40 or weight >100 pounds over ideal body weight
• Pregnant or interested in becoming pregnant in the next 3 years
• Known allergy to cobalt, chromium, molybdenum, titanium or stainless steel
• Other surgical procedures within the last 30 days
• Current participation in another investigational study for a similar purpose
• Any condition that would prevent the patient from providing voluntary informed consent

Visit www.spinecore.com for more information.