Post Market Observational Trial for the PerQdisc Nucleus Replacement Device

Study Overview
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Brief Summary
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PerQdisc PMCF1 is a post-market clinical follow-up observational trial to follow subjects receiving a PerQdisc spinal implant for a duration of 5 years.

Detailed Description
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This study will be a prospective, open-label, multi-center post-market observational study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System. Primary endpoints will be used to assess the safety and efficacy of the PerQdisc device.

Official Title
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PerQdisc PMCF1 Observational Trial to Evaluate the Clinical Performance and Safety of the PerQdisc Nucleus Replacement Device

Conditions
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Degenerative Disc Disease, Chronic Low-back Pain

Intervention / Treatment
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* Drug: PerQdisc


Participation Criteria
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Eligibility Criteria
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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 but must have a single level identified as the pain generator. Patient has adequate disc height (6mm) at the level to be treated Patient is not responsive to conservative, non-surgical treatment for back pain. Patient has signed the approved Informed Consent Form. Exclusion Criteria: Patient has less than 6 mm of disc height. Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable). Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities. Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm. Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis. Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to Spine Intervention Society (SIS) guidelines (diagnostic, contrast controlled). 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 or local systemic infection. Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including Acquired Immune Deficiency Syndrome (AIDS), AIDS related Complex (ARC), and Human Immunodeficiency Virus (HIV). Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management. Patient has osteopenia of the spine (T-score of -1.0 or lower). A Bone Densiometry (DEXA) scan should be performed to rule out patients considered at risk for osteopenia. Patient has morbid obesity defined as a Body Mass Index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight. Patient has a known allergy to silicone or barium sulfate. Patient has a significant disc herniation at the level to be treated. Significant is defined as a large extruded herniation that creates a risk for expulsion. Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes). Patient has motion of less than 3 degrees on pre-operative lateral flexion/extension radiographs. 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 balloons during fluoroscopy. Patient has a disc space that is too narrow for implantation.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Discogenic Low Back Pain<br>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 but must have a single level identified as the pain generator. Patient has adequate disc height (6mm) at the level to be treated Patient is not responsive to conservative, non-surgical treatment for back pain. | Drug: PerQdisc<br>* Observational trial to collect post-market safety and efficacy information in a limited number of human patients<br>* Other names: PerQdisc Nucleus Replacement System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PerQdisc Perfomance | Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool | 6 months post implant | 
| PerQdisc Perfomance | Change in Oswestry Disability Index (ODI) comparing baseline to follow up visits using a patient-reported outcome tool | 12 months post implant | 
| PerQdisc Safety | Incidence of device expulsion and device fracture following surgery based on follow up X-rays and MRI's | 6 months post implant | 
| PerQdisc Safety | Incidence of device expulsion and device fracture following surgery based on follow up x-rays and MRI's | 12 months post implant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Secondary Surgeries | Incidence of revision surgery at the index level or other secondary lumbar surgery at a non-index level | 6 months, 12 months, and 5 years following surgery | 
| Maintenance of Disc Height | Intervertebral disc height (in mm) as measured on MRI post-surgery compared to baseline | 6 months, 12 months, and 5 years following surgery | 
| Maintenance of Range of Motion | Measurement of range of motion (expressed in degrees) at the index and adjacent levels at baseline compared to post-surgical follow-up using flexion/extension x-rays. | 6 months, 12 months, and 5 years following surgery | 
| Maintenance of Neurologic Status | Physical assessment evaluating nerve compression at baseline and post-surgical follow up using pain, motor strength, and sensation feedback from the patient on a 0 (no compression) to 5 (major compression) scale. | 6 months, 12 months, and 5 years following surgery | 
| Use of Pain Medications | Change in level of pain medication used comparing baseline to follow up visits based on a medication scale ranging from 0 to 4. 0 (no meds) to 4 (high dose opioids) | 6 months, 12 months, and 5 years following surgery |