"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorSpinal Stabilization Technologies
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- PerQdisc Nucleus Replacement System
Treatment groups
72 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov