A-MAV™ Anterior Motion Segment Replacement

NCT00635934 | Completed DMC

• 1 other identifier: P04-05
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 3

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.

Conditions

Spinal Diseases

Keywords

Lumbar Degenerative Disc Disease at One Level from L4-S1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

A-MAV™disc

EXPERIMENTAL

Device: A-MAV™ disc

Interventions

A-MAV™ disc DEVICE

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.

Also known as: A-MAV™

A-MAV™disc

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (3)

Hughston Clinic

Columbus, Georgia, 31908, United States

Location

Orthopedic Center of St. Louis

Chesterfield, Missouri, 63017, United States

Location

Central Texas Spine

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: December 1, 2005
• Primary Completion: October 1, 2009
• Study Completion: May 1, 2010
• Last Updated: September 18, 2018

Record last verified: 2011-10

Locations

US (3)