Post Market Observational Trial for the PerQdisc Nucleus Replacement Device (NCT05105490) | Clinical Trial Compass
WithdrawnNot Applicable
Post Market Observational Trial for the PerQdisc Nucleus Replacement Device
Stopped: Study withdrawn upon CE mark receipt
Germany0Started 2021-12-31
Plain-language summary
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.
Who can participate
Age range21 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…