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"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) — LOPAIN2  

Degenerative Disc Disease Clinical Trial

Official title:
"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

Clinical Trial Summary

This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.

Clinical Trial Description

This study will be a prospective, open-label, multi-center study that will collect additional safety and efficacy data for the minimally 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 by maintaining disc height while preserving range of motion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05508360
Study type Interventional
Source Spinal Stabilization Technologies
Contact Andy Murillo
Phone 1 (210) 632-5444
Email amurillo@sstspine.com
Status Recruiting
Phase N/A
Start date August 22, 2022
Completion date August 22, 2029
View Details
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