Status:
COMPLETED
A-MAV™ Anterior Motion Segment Replacement
Lead Sponsor:
Medtronic Spinal and Biologics
Conditions:
Spinal Diseases
Eligibility:
All Genders
18-70 years
Phase:
NA
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 degenerativ...
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 L...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00635934
Start Date
December 1 2005
End Date
May 1 2010
Last Update
September 18 2018
Active Locations (3)
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1
Hughston Clinic
Columbus, Georgia, United States, 31908
2
Orthopedic Center of St. Louis
Chesterfield, Missouri, United States, 63017
3
Central Texas Spine
Austin, Texas, United States, 78731