NCT05732818

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy 3

Clinical Investigation Plan First in Human Trial Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy "LOPAIN3"

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Spinal Stabilization Technologies · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.

Detailed description

The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects. Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.

Conditions

• Back Pain With Radiation
• Radiculopathy
• Back Pain
• Disc Herniation
• Herniated Nucleus Pulposus
• Herniated Disc
• Disc Injury
• Disk Herniated Lumbar

Interventions

Type	Name	Description
DEVICE	PerQdisc Nucleus Replacement System	Lumbar spine disc nucleus replacement system. 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.

Timeline

• Start date: 2023-06-16
• Primary completion: 2026-09-16
• Completion: 2027-06-16
• First posted: 2023-02-17
• Last updated: 2026-01-08

Locations

2 sites across 2 countries: Paraguay, Uzbekistan