NCT04141098

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Spinal Stabilization Technologies · Industry
• Sex: All
• Age: 21 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 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.

Conditions

• Degenerative Disc Disease
• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.	All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy.

Timeline

• Start date: 2019-09-19
• Primary completion: 2023-02-01
• Completion: 2023-08-07
• First posted: 2019-10-28
• Last updated: 2025-05-21

Locations

1 site across 1 country: Paraguay