Safety Study for An Artificial Disc Nucleus Replacement to Treat Chronic Low Back Pain

May 15, 2025 updated by: Spinal Stabilization Technologies

Safety Study for An Artificial Disc Replacement "PerQdisc Nucleus Replacement Device" NUCLEUS 181

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will be a prospective, open-label, multi-center study that will collect safety data for the minimally invasive PerQdisc Nucleus Replacement Device (NRD). 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
      • Aalst, Belgium
        • Onze Lieve Vrouw Ziekenhuis
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital
  • Croatia
      • Zagreb, Croatia
        • Clinical Hospital Dubrava
  • Germany
      • Deggendorf, Germany, 94469
        • Donauisar Klinikum Deggendorf

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient is skeletally mature and between 22 and 60 years of age.
  • Patient has degenerative disc disease (DDD) at a single level between L1 and S1 as confirmed by:History and clinical findings suggestive of symptomatic DDD, Darkened disc on MRI in T2 weighted images, and decreased disc height (decreased greater than 2 mm compared to adjacent cranial or caudal disc height) with minimum disc height of 6 mm.
  • Patient has pre-operative back pain VAS score of greater than or equal to 4 (0-10 scale).
  • Patient has pre-operative Oswestry Low Back Disability 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.
  • Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs.
  • Patient has ankylosing spondylitis or other spondyloarthropathy.
  • Patient has isthmic spondylolisthesis or degenerative spondylolisthesis greater than 2 mm.
  • Patient has congenital stenosis or epidural lipomatosis.
  • Patient has significant facet disease.
  • Patient has any known active malignancy.
  • Patient has previously undergone immunosuppressive therapy.
  • Patient has active local or system 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 has osteopenia of the spine (T-score less than 1.0). All females 45 years of age or older and all males 50 or older should have a DEXA scan to confirm this exclusion.
  • Patient has morbid obesity defined as body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs) over ideal body weight.
  • Patient is pregnant or plans to become pregnant during the course of the study.
  • 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 disables, prisoner, chronic alcohol/ substance abuser)
  • Patient has a disc herniation
  • Patient has a 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.
  • Patient has a disc space that is too narrow.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Nucleus Replacement
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Device: PerQdisc® Nucleus Replacement Device.
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of revision surgery at the treated level
Time Frame: 90 days
Number of patients requiring surgeries to revise the implanted level in the spine divided by the total number of implant surgeries. Express in percentage (0-100)
90 days
Rate of expulsion
Time Frame: 90 Days
The rate of device expulsion. The number of patients determined to have expulsed devices divided by the total number of patients receiving implants.Expressed in percentage (0-100)
90 Days
Rate of new herniation at the treated level as determined by MRI
Time Frame: 90 days
Herniation will be determine by MRI. A herniation will be defined as violation of the intervertebral annulus, including expulsion of nucleus material. The response will be yes/no as assessed by the radiologist. Rate will be determined by total number of herniations divided by the total number of implanted devices. Expressed in percentage (0-100)
90 days
Rate of new radiculopathy
Time Frame: 90 days
New complaint of leg pain will be recorded as a yes/no response. Any complaint of new radiculopathy not seen preoperatively. Expressed as total number of new radiculopathy complaints divided by total number of patients. Expressed in percentage (0-100)
90 days
MRI assessment of the endplate Modic changes.
Time Frame: 90 days
Changes to vertebral endplates will be assigned based on Modic classification of I,II or III comparing preoperative grade to grade at 90 days. Possible scores are I,II or III
90 days
Rate of surgical procedure technical success
Time Frame: 90 days
The number of devices successfully implanted divided by the number of successfully devices implanted + unsuccessful implants. Output will be in percentage (0-100)
90 days
Improvement in degree of disability as measured by the Oswestry Disability Index (ODI)
Time Frame: 90 days
Change in absolute Oswestry Index score at 90 days compared to the preoperative score, range is 0-100
90 days
Improvement in back pain as measured by 10-centimeter Visual Analog Scale (VAS)
Time Frame: 90 days
Change in the Visual Analogue Scale (VAS) for back and leg pain on a scale of 0-10 cm comparing preoperative scores to 90 days post-operative.
90 days

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Spinal Stabilization Technologies

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Michael Hess, MD, London Spine Clinic/ATOS-Klinik

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • N181

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

product manufactured in and exported from the U.S.

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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