"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Colombia72 participantsStarted 2022-08-22
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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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 fusion is allowed as long as there are no neurologic deficits in the lower extremities.
* Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.
* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
* Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).
* Patient has any know…