A-MAV™ Anterior Motion Segment Replacement
Primary Purpose
Spinal Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A-MAV™ disc
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Diseases focused on measuring Lumbar Degenerative Disc Disease at One Level from L4-S1
Eligibility Criteria
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
Sites / Locations
- Hughston Clinic
- Orthopedic Center of St. Louis
- Central Texas Spine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A-MAV™disc
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00635934
First Posted
March 7, 2008
Last Updated
September 13, 2018
Sponsor
Medtronic Spinal and Biologics
1. Study Identification
Unique Protocol Identification Number
NCT00635934
Brief Title
A-MAV™ Anterior Motion Segment Replacement
Official Title
A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Spinal and Biologics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Diseases
Keywords
Lumbar Degenerative Disc Disease at One Level from L4-S1
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A-MAV™disc
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
A-MAV™ disc
Other Intervention Name(s)
A-MAV™
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Time Frame
24 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hughston Clinic
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31908
Country
United States
Facility Name
Orthopedic Center of St. Louis
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Central Texas Spine
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
12. IPD Sharing Statement
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A-MAV™ Anterior Motion Segment Replacement
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