- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04141098
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy (LOPAIN1)
July 13, 2021 updated by: Spinal Stabilization Technologies
Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy - LOPAIN1
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
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- 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
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Asunción, Paraguay, 1101
- Sanatorio Americano
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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
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 |
Intervention / Treatment |
---|---|
Experimental: Total Nucleus Replacement
All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post surgical change in degree of disability
Time Frame: 6 months
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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.
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6 months
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Post surgical change in back pain: Visual Analogue Scale
Time Frame: 6 months
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Patient reported outcomes will be reported using the Visual Analogue Scale (0-100mm).
Higher scores indicate greater levels of back pain.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 10, 2019
Primary Completion (Anticipated)
February 28, 2022
Study Completion (Anticipated)
August 31, 2022
Study Registration Dates
First Submitted
October 24, 2019
First Submitted That Met QC Criteria
October 25, 2019
First Posted (Actual)
October 28, 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIP-003
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
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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