Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy (LOPAIN2)
This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.
• Patient is skeletally mature aged 22-70.
• Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.
• Patient has adequate disc height (6mm) at the level to be treated
• Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).
• Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40/100)
• Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)
• Patient has signed the approved Informed Consent Form.
• All surgeries must be approved by the Medical Advisory Board (MAB)