NCT04004156

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
4 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

June 26, 2019

Last Update Submit

May 15, 2025

Conditions

Degenerative Disc DiseaseChronic Low-back Pain

Keywords

Degenerative Disc DiseaseDDDChronic Low-back PainLow Back PainNucleus Replacement DeviceNucleus PulposusDisc ReplacementBack painLeg painLumbar Spinal Fusion

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (1)

Nucleus Replacement

EXPERIMENTAL

All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.

Device: PerQdisc® Nucleus Replacement Device.

Interventions

PerQdisc® Nucleus Replacement Device.DEVICE

All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.

Nucleus Replacement

Eligibility Criteria

Age22 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Onze Lieve Vrouw Ziekenhuis

Aalst, Belgium

Location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Clinical Hospital Dubrava

Zagreb, Croatia

Location

Donauisar Klinikum Deggendorf

Deggendorf, 94469, Germany

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationLow Back PainBack Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Hess, MD

    London Spine Clinic/ATOS-Klinik

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This is an open label study. Patients that are unable to receive an implant due to intraoperative exclusion will receive standard of care
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

July 1, 2019

Study Start

March 1, 2019

Primary Completion

March 17, 2022

Study Completion

January 23, 2023

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)BE(1)CR(1)DE(1)