A-MAV™ Anterior Motion Segment Replacement

Study Overview
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Brief Summary
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The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.

Detailed Description
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For this clinical trial, there is only one treatment group- patients receiving the A-MAV™ Anterior Motion Segment Replacement via an anterior surgical approach in the lumbar region of the spine from L4-S1.

Official Title
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A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease

Conditions
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Spinal Diseases

Intervention / Treatment
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* Device: A-MAV™ disc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has back and/or radicular pain with degeneration of the disc as confirmed by patient history, physical examination, and radiographic studies with one or more of the following factors: instability as defined by > 5° angulation osteophyte formation of facet joints or vertebral endplates decreased disc height, on average by >2mm, relative to the next adjacent vertebral segment scarring/thickening of ligamentum flavum, annulus fibrosis, or facet joint capsule herniated nucleus pulposus facet joint degeneration/changes vacuum phenomenon Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment Has intact facet joints at the involved vertebral levels documented by CT and/or MRI Has preop Oswestry score≥30 Has preop back pain score ≥8 Age 18 to 70 yrs, inclusive and is skeletally mature Has not responded to non-operative treatment for 6 mos If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery Is willing and able to comply with the study plan and sign the Patient Informed Consent Form Exclusion Criteria: Has primary diagnosis of a spinal disorder other than DDD at involved level Had previous anterior lumbar spinal surgery at involved level Had previous posterior lumbar spinal fusion surgical procedure at involved level Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques Requires surgical intervention at more than 1 lumbar level Has severe pathology of facet joints of involved vertebral bodies Has facet arthritis or any posterior element insufficiency Has spondylolisthesis Has mid-sagittal stenosis of <8mm, based on remaining canal diameter Has rotatory scoliosis at involved level Has lumbar scoliosis with >11° sagittal plane deformity Had previous trauma to L4, L5, or S1 levels in compression or burst Meets any of the following criteria: Previous diagnosis of osteoporosis, osteopenia, or osteomalacia; postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; male over age 60 that has sustained a non-traumatic hip or spine fracture. If Yes to any of these, a DEXA scan is required. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded Had previous lumbar spinal fusion at adjacent level Bone growth stimulator use in spine Has obesity defined by BMI greater than or equal to 40 Has arachnoiditis Has a non-contained or extruded herniated nucleus pulposus with acute nerve root compression Has condition that requires postop medications that interfere with bone metabolism, such as chronic steroid use or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia Has presence or prior history of malignancy (except for basal cell carcinoma of skin) Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy Is mentally incompetent. If questionable, obtain psych consult Has a Waddell Signs of Inorganic Behavior score of 3 or greater Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease Is prisoner Is pregnant Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse Has history of autoimmune disease Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery Has history of any endocrine or metabolic disorder known to affect osteogenesis Has any disease that would preclude accurate clinical evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A-MAV™disc<br> | Device: A-MAV™ disc<br>* The A-MAV™ device is a spinal arthroplasy system intended to replace a damaged spinal disc. It is inserted using an anterior surgical approach and aims to reduce low back pain and maintain disc height at the affected level.<br>* Other names: A-MAV™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Success= Oswestry Disability Index success; Maintenance or improvement in neurological status; No serious AE classified as implant or implant/surgical procedure associated; No additional surgical procedure classified as a failure |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disc height; SF-36; Back Pain Status; Leg Pain Status; Patient Satisfaction; Patient Global Perceived Effect; Other Measurements-Radiographic; Return to Work; Doctor's Perception of Results |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Degenerative Disc Disease at One Level from L4-S1