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Safety Study for An Artificial Disc Replacement to Treat Chronic Low Back Pain

Degenerative Disc Disease Clinical Trial

Official title:
Safety Study for An Artificial Disc Replacement "PerQdisc Nucleus Replacement Device" NUCLEUS 181

Clinical Trial Summary

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.

Clinical Trial Description

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). 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 by maintaining disc height while preserving range of motion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04004156
Study type Interventional
Source Spinal Stabilization Technologies
Contact
Status Active, not recruiting
Phase N/A
Start date March 1, 2019
Completion date June 30, 2022
View Details
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