Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1)

July 13, 2021 updated by: Spinal Stabilization Technologies

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Asunción, Paraguay, 1101
        • Sanatorio Americano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is skeletally mature and between 21 and 60 years of age.
  • Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1
  • History and clinical findings suggestive of symptomatic DDD:

Darkened disc on MRI in T2 weighted images Patients with at least 6 months of low back pain (location defined as the space between the lower margin of the posterior rib cage and horizontal gluteal fold) that is resistant to nonsurgical conservative therapy.

  • Patient has adequate disc height (~6mm) at the level to be treated
  • Patient has pre-operative Oswestry Low Back Disability score of greater than or equal to 40 (0-100 scale).
  • Patient has pre-operative back pain VAS score of greater than or equal to 40 (0-100 scale)
  • Patient has received conservative, non-surgical treatment for back pain for a minimum of 6 months.
  • Patient has signed the approved Informed Consent Form.

Exclusion Criteria:

  • Patient has had prior lumbar spine surgery
  • Spinal fusion at any level
  • Patient has ankylosing spondylitis or other spondyloarthropathy.
  • Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
  • Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.
  • Patient has significant facet disease.
  • Patient has had prior lumbar spine surgery
  • Spinal fusion at any level
  • Patient has any known active malignancy.
  • Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.
  • Patient has active local or systemic infection.
  • Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease, including AIDS, ARC and HIV.
  • Patient has diabetes mellitus (Type 1 or 2), requiring daily insulin management.
  • Patient is pregnant or plans to become pregnant during the course of the study. Pregnancy ruled out by urine or serum HCG.
  • Patient has a known allergy to silicone (polymer and balloon material) or barium sulfate (polymer).
  • Patient participated in another investigational drug or device study within the past 30 days.
  • Patient belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self- assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)
  • Patient has a significant disc herniation at the level to be treated
  • Patient has a significant Schmorl's node in the level to be treated

Intraoperative exclusion criteria:

  • Protrusion of the 20A imaging balloon up to or beyond the outer margin of the vertebra during the imaging steps.
  • Patient has a violated endplate as determined by imaging balloon during fluoroscopy
  • Patient has a disc space that is too narrow for implantation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Total Nucleus Replacement
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post surgical change in degree of disability
Time Frame: 6 months
Patient reported outcomes for degree of disability will be monitored using the Oswestry Disability Index (scale of 0-100). Higher scores indicate greater level of disability.
6 months
Post surgical change in back pain: Visual Analogue Scale
Time Frame: 6 months
Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm). Higher scores indicate greater levels of back pain.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 19, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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