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.
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)
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)
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)
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)
Clinical Trial Status
Type
Enrollment
Number of Patients
Planning
Nucleus 161
Feasibility
Complete
6 Patients
1 year follow up complete
2 year follow up complete
Nucleus N181
Safety Study:
Chronic low back pain in single-level degenerative disc disease.
Not Enrolling
15 Patients
First patient enrolled 05/2019
2-year follow-up
LOPAIN1
Not Enrolling
50 Patients
First patient enrolled
10/10/2019
2-year follow-up
Safety and Efficacy:
Chronic low back pain in multi-level degenerative disc disease.
Safety and Efficacy: Chronic low back
pain in multi-level degenerative disc disease.
LOPAIN2
Enrolling:
Latin America
72 Patients
First patient enrolled 9/26/2023
5-year follow-up
Early Feasibility:
PerQdisc implantation
w/concurrent discectomy procedure