
Clinical Trials
Nucleus 161
Feasibility Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
N161 was a clinical trial to study the feasibility of implanting the PerQdisc device in the lumbar spine of patients suffering from chronic low back pain. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging.
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Nucleus 181
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
N181 is a clinical trial to study the safety of implanting PerQdisc device in the lumbar spine of patients suffering from chronic low back pain. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging.
(Click here for more information)
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LOPAIN1
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN1 is a clinical trial designed to study the safety and efficacy of the PerQdisc device in patients suffering from chronic low back pain due to one or more degenerated lumbar discs. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging.
(Click here for more information)
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LOPAIN2
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN2 is a clinical trial designed to study the safety and efficacy of implanting the PerQdisc device in patients suffering from chronic low back pain due to one or more degenerated lumbar discs. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
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LOPAIN3
Safety Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
LOPAIN3 is a clinical trial designed to gather clinical data on the feasibility, safety, and efficacy of performing the PerQdisc procedure concurrently following successful discectomy, using a minimally invasive posterolateral (MIPL) approach in patients presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression .. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
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DISCPAIN1
Feasibility Study for a Lumbar Spine Disc Nucleus Replacement (PerQdisc).
DISCPAIN1 is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc device in the treatment of patients suffering from single level discogenic back pain caused by degenerative disc disease. Patients are assessed for pain and disability using standardized patient reported outcome measures as well as X-ray and MRI imaging. (Click here for more information)
Clinical Trial Status
Type
Enrollment
Study Duration
Nucleus 161
Feasibility
Closed
1 year follow up complete
2 year follow up complete
Nucleus N181
Safety Study:
Chronic low back pain in single-level degenerative disc disease.
Closed
2-year follow-up
LOPAIN1
Safety and Efficacy:
Chronic low back pain in multi-level degenerative disc disease.
Closed
2-year follow-up
LOPAIN2
Safety and Efficacy: Chronic low back
pain in multi-level degenerative disc disease.
Enrolling:
Latin America
Asia
5-year follow-up
LOPAIN3
Early Feasibility:
PerQdisc implantation
w/concurrent discectomy procedure
Enrolling:
Latin America
Asia
Eastern Europe
2-year follow-up
DISCPAIN1
Feasibility, Safety and Efficacy: PerQdisc implantation in
single-level discogenic back pain