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Trial record 2 of 2 for:    lopain

Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04141098
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Spinal Stabilization Technologies

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Chronic Low-back Pain Device: All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1
Actual Study Start Date : October 10, 2019
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Total Nucleus Replacement
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141098


Contacts
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Contact: Jeffrey Griebel 800-484-1588 jgriebel@sstspine.com

Locations
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Paraguay
Sanatorio Americano Recruiting
Asunción, Paraguay, 1101
Contact: Carlos Cetraro       radiosolutionspy@gmail.com   
Principal Investigator: Francisco Duarte, MD         
Sponsors and Collaborators
Spinal Stabilization Technologies
Investigators
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Study Chair: Michael Hess, MD London Spine Clinic/ATOS-Klinik
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Responsible Party: Spinal Stabilization Technologies
ClinicalTrials.gov Identifier: NCT04141098    
Other Study ID Numbers: CIP-003
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spinal Stabilization Technologies:
Degenerative Disc Disease
DDD
Chronic Low-back Pain
Disc Herniation
Nucleus Replacement
Low back pain
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases