Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
WithdrawnNCT05105490
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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)
PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.
Study details
- Official title
- PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device
- Interventions
- Drug: PerQdisc
- Sponsor
- Spinal Stabilization Technologies
- Start date
- 2021-12-31
- Primary completion
- 2021-12-31
- Sex
- All
- Age range
- from 21 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Germany
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient is skeletally mature and between 21 and 60 years of age. * Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but must have a single level identified as the pain generator. * Patient has adequate disc height (6mm) at the level to be treated * Patient is not responsive to conservative, non-surgical treatment for back pain. * Patient has signed the approved Informed Consent Form. 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 Spine Intervention Society (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 Acquired Immune Deficiency Syndrome (AIDS), AIDS related Complex (ARC), and Human Immunodeficiency Virus (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 Bone Densiometry (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 be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05105490