A-MAV™ Anterior Motion Segment Replacement

A Prospective, Non-Randomized Pilot Clinical Investigation of the A-MAV™ Anterior Motion Segment Replacement in Patients With Lumbar Degenerative Disc Disease

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.

Study Overview

• Status: Completed
• Conditions: Spinal Diseases
• Intervention / Treatment: Device: A-MAV™ disc

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Columbus, Georgia, United States, 31908
      • Hughston Clinic
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Orthopedic Center of St. Louis
  • Texas
    • Austin, Texas, United States, 78731
      • Central Texas Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A-MAV™disc	Device: A-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.; Other Names: A-MAV™

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): May 1, 2010

Study Registration Dates

• First Submitted: March 7, 2008
• First Submitted That Met QC Criteria: March 13, 2008
• First Posted (ESTIMATE): March 14, 2008

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Lumbar Degenerative Disc Disease at One Level from L4-S1
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: P04-05