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

Medtronic Spinal and Biologics3 sites in 1 country53 target enrollmentDecember 2005

ConditionsSpinal Diseases

Overview

Phase: N/A
Intervention: Not specified
Conditions: Spinal Diseases
Sponsor: Medtronic Spinal and Biologics
Enrollment: 53
Locations: 3
Primary Endpoint: 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
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2005

End Date

May 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Spinal and Biologics

Responsible Party

Sponsor

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

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

Outcomes

Primary Outcomes

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 Outcomes

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)