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

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: Active, not recruiting
• Conditions: Chronic Low-back Pain; Degenerative Disc Disease
• Intervention / Treatment: Device: PerQdisc® Nucleus Replacement Device.

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: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 20 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Rate of revision surgery at the treated level	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	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	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	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.	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	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)	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)	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

• Sponsor: Spinal Stabilization Technologies

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): July 1, 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

• Keywords: Low Back Pain; Back pain; DDD; Degenerative Disc Disease; Leg pain; Chronic Low-back Pain; Nucleus Replacement Device; Nucleus Pulposus; Disc Replacement; Lumbar Spinal Fusion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: N181

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No