Spinal Diseases
Conditions
Keywords
Lumbar Degenerative Disc Disease at One Level from L4-S1
Brief summary
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
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.
Interventions
DEVICEA-MAV™ disc
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.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed