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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
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.
Sanatorio Americano
Asunción, Paraguay
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.
Time frame: 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.
Time frame: 6 months
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