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.
Full Title of Study: “Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nuclectomy – LOPAIN1″
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 30, 2021
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.
- 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.
Arms, Groups and Cohorts
- Experimental: Total Nucleus Replacement
- All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
Clinical Trial Outcome Measures
- 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.
- 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.
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Spinal Stabilization Technologies
- Provider of Information About this Clinical Study
- Overall Official(s)
- Michael Hess, MD, Study Chair, London Spine Clinic/ATOS-Klinik
- Overall Contact(s)
- Jeffrey Griebel, 800-484-1588, firstname.lastname@example.org
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