Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy

NCT04141098 | Terminated

• 1 other identifier: CIP-003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Disc Disease; Chronic Low-back Pain

Keywords

Degenerative Disc Disease; DDD; Chronic Low-back Pain; Disc Herniation; Nucleus Replacement; Low back pain

Outcome Measures

Primary Outcomes (2)

• Post surgical change in degree of disability

  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

  Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm). Higher scores indicate greater levels of back pain.

  6 months

Study Arms (1)

Total Nucleus Replacement

EXPERIMENTAL

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

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

Interventions

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

Total Nucleus Replacement

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Spinal Stabilization Technologies: lead

Study Sites (1)

Sanatorio Americano

Asunción, 1101, Paraguay

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michael Hess, MD

  London Spine Clinic/ATOS-Klinik

  STUDY CHAIR

• Jeff Golan, MD

  Jewish General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label study. Patients will receive one implant if they meet all inclusion/exclusion criteria after a review by the Medical Advisory Board (MAB). Patients that cannot receive the implant due to an intraoperative exclusion, will receive standard of care treatment.

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 28, 2019
• Study Start: September 19, 2019
• Primary Completion: February 1, 2023
• Study Completion: August 7, 2023
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)