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

NCT05508360 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-03-03

No results posted yet for this study

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.

Conditions

  • Degenerative Disc Disease
  • Chronic Low-back Pain

Interventions

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.

Sponsors & Collaborators

  • Spinal Stabilization Technologies

    lead INDUSTRY

Principal Investigators

  • Jeff Golan, MD · Jewish General Hospital

  • Michael Hess, MD · London Spine Clinic/ATOS-Klinik

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2027-08-22
Completion
2030-08-22

Countries

  • Colombia
  • Panama
  • Paraguay
  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05508360 on ClinicalTrials.gov