This study is a First in Human, prospective, multi-center clinical study intended to collect safety and performance information for the Spinal Stabilization Technologies PerQdisc® Nucleus Replacement System and procedure concurrently following a successful discectomy using a minimally invasive posterolateral (MIPL) approach. Patients that are at least 21 years or older, presenting with symptomatic radiculopathy from a focal lumbar disc herniation that requires surgical decompression will be included in this study.
The PerQdisc® Nucleus Replacement System is comprised of an in situ formed silicone-based prosthesis with its delivery system, implant fill device, dispenser gun, a disc access system and two different imaging balloons. For this trial, the PerQdisc® will be implanted using minimally invasive posterolateral (MIPL) approach. The implanted device provides an effective means of replacing dysfunctional nucleus pulposus while supporting the native annulus fibrosis to bridge annular defects. Patients that suffer clinically significant lumbar disc herniations currently undergo discectomy procedures to relieve nerve root compression. The standard discectomy procedure does not correct the annular defect associated with the herniation and is associated with a risk for re-herniation. In addition, the progressive loss of disc height and overall lack of disc turgor and weight bearing capacity is thought to be associated with downstream degenerative changes that may lead to chronic low back pain and premature spondylosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Lumbar spine disc nucleus replacement system. 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.
Sanatorio Americano
Asunción, Paraguay
Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova
Tashkent, Tashkent, Uzbekistan
Safety: Number of Patients with Serious Adverse Events related to the PerQdisc
Freedom from device- and procedure-related serious adverse events definitely related to the PerQdisc Device or the PerQdisc Surgical Procedure
Time frame: 12 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time frame: 3 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time frame: 6 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time frame: 12 months
Performance: ODI
Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient reported outcome tool
Time frame: 24 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 3 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 6 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 12 months
Performance: VAS Back
Change in back pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 24 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 3 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 6 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 12 months
Performance: VAS Leg
Change in leg pain values as measured by the 100 millimeter Visual Analog Scale (VAS)
Time frame: 24 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time frame: 3 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time frame: 6 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time frame: 12 months
Performance: Analgesic Score
Change in level of pain medication used comparing baseline to follow up visits based on a medication scale from 0 (no meds) to 4 (high dose opioids)
Time frame: 24 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Time frame: 3 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Time frame: 6 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Time frame: 12 months
Safety: Number of Patients with Reherniation/recurrent disc herniation
Freedom from reherniation/recurrent disc herniation
Time frame: 24 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time frame: 3 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time frame: 6 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time frame: 12 months
Safety: Number of Patient that Received Supplemental fixation
Freedom from supplemental fixation at the index level(s) including basivertebral nerve ablation, radiofrequency ablation or spinal cord stimulator
Time frame: 24 months
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