NCT04004156

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Spinal Stabilization Technologies · Industry
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease
• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	PerQdisc® Nucleus Replacement Device.	All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-03-17
• Completion: 2023-01-23
• First posted: 2019-07-01
• Last updated: 2025-05-21

Locations

4 sites across 4 countries: Belgium, Canada, Croatia, Germany