A-MAV™ Anterior Motion Segment Replacement

Not Applicable

Completed

Conditions: Spinal Diseases

Registration Number: NCT00635934

Lead Sponsor: Medtronic Spinal and Biologics

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 53

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3): Hughston Clinic
🇺🇸
Columbus, Georgia, United States
Orthopedic Center of St. Louis
🇺🇸
Chesterfield, Missouri, United States
Central Texas Spine
🇺🇸
Austin, Texas, United States
Hughston Clinic
🇺🇸Columbus, Georgia, United States