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Clinical Trials

Nucleus 161 

Feasibility Study for an Artificial Spinal Disc Replacement (PerQdisc). 

N161 is 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 An Artificial Disc 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 

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy. 

The LOPAIN1 study is a prospective, open-label, multi-center study that will collect safety and efficacy data for the less invasive PerQdisc Nucleus Replacement Device (NRD). Patients will have degenerative disc disease (DDD) in one or more lumbar discs. The NRD is used for surgical replacement of a single nucleus pulposus between spinal lumbar discs L1-S1 using an anterior or lateral transpsoas approach. Currently, the surgical gold standard involves spinal fusion of the affected vertebral bodies, reducing range of motion and increasing stress on other vertebral bodies. The goal of nucleus replacement is to reduce chronic low back pain while maintaining disc height and preserving range of motion.  (Click here for more information.)

Clinical Trial Status
Type
Enrollment
Number of Patients
Planning
Nucleus 161
Feasibility
Complete
6
1 year follow up complete
2 year follow up in progress
Safety/CE Registry Chronic low back pain in single-level degenerative disc disease.
Enrolling:
  • Belgium
  • Canada
  • Croatia
  • Germany
Additional countries will be added following Ethics Committee approvals.
15
First patient enrolled 05/2019
LOPAIN1
Enrolling
34 Patients
First patient enrolled
10/10/2019
Safety and Feasibility
Chronic low back pain in multi-level degenerative disc disease.
TBA
Registry
FDA/Health Canada
Future Trial
TBA
Planning