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Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy

TerminatedNot applicableNCT04141098
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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 that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device deployed to reduce chronic low back pain.

Study details

Official title
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1
Interventions
  • Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Sponsor
Spinal Stabilization Technologies
Start date
2019-09-19
Primary completion
2023-02-01
Sex
All
Age range
from 21 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
Paraguay
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 * History and clinical findings suggestive of symptomatic DDD: Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy. * Patient has adequate disc height (\~6mm) at the level to be treated * Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale). * Patient has pre-operative back pain VAS score of greater than or equal to 40 (0-100 scale) * Patient has received conservative, non-surgical treatment for back pain for a minimum of 6 months. * Patient has signed the approved Informed Consent Form. Exclusion Criteria: * Patient has had prior lumbar spine surgery * Spinal fusion at any level * Patient has ankylosing spondylitis or other spondyloarthropathy. * Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm. * Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis. * Patient has significant facet disease. * Patient has had prior lumbar spine surgery * Spinal fusion at any level * 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 local or 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 is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by urine or serum HCG. * Patient has a known allergy to silicone (polymer and balloon material) or barium sulfate (polymer). * Patient participated in another investigational drug or device study within the past 30 days. * Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self- assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser) * Patient has a significant disc herniation at the level to be treated * P…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04141098