NCT00635934CompletedNot Applicable
A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease
Medtronic Spinal and Biologics6 sites in 1 country53 target enrollmentStarted: December 1, 2005Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 53
- Locations
- 6
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
A-MAV™disc
Experimental
Intervention: A-MAV™ disc (Device)
Outcomes
Primary Outcomes
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
Time Frame: 24 Months
Secondary Outcomes
- 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)
Investigators
Study Sites (6)
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