"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
RecruitingNot applicableNCT05508360
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)
- Interventions
- Device: PerQdisc Nucleus Replacement System
- Sponsor
- Spinal Stabilization Technologies
- Start date
- 2022-08-22
- Primary completion
- 2027-08-22
- Sex
- All
- Age range
- from 22 Years
- Results posted
- No results posted in this snapshot
- Countries
- Colombia, Costa Rica, Panama, Paraguay, Uzbekistan
- Total sites listed
- 11
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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 known active malignancy. * Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed. * Patient has active or local systemic infection. * Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV. * Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management. * Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia. * Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight. * Patient has a known allergy to silicone or barium sulfate. * Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion. * Patient has a significant Schmorl's node in the level to…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05508360