"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Patient has less than 6 mm of disc height. * Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable). * Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusi