Clinical Study of the Amedica Corporation Valeo OL Interbody Fusion Devices for Posterior Lumbar Interbody Fusion

Amedica Corporation2 sites in 1 country100 target enrollmentFebruary 2012

ConditionsDisc Degeneration of Pfirrmann Grade III or Greater Degenerative Spondylolisthesis Isthmic Spondylolisthesis of Grade I or II

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Disc Degeneration of Pfirrmann Grade III or Greater
Sponsor: Amedica Corporation
Enrollment: 100
Locations: 2
Primary Endpoint: Roland Morris Disability Questionnaire (RMDQ)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study randomizes degenerative spondylolisthesis and/or degenerative disc patients into two groups: one to receive a new ceramic implant and a control group with a more traditional PEEK plastic implant. The procedure uses a single oblique cage in each group. The study will measure and compare pain and disability improvement with the two implanted devices over a period of two years. The fusion status will also be judged with plane x-rays and one CT scan.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

March 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amedica Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female patients age 18-75 years
•Chronic low back pain unresponsive to at least six months of conservative care
•MRI and standing x-ray evidence of Pfirrmann Grade III or greater disc degeneration and/or degenerative or isthmic spondylolisthesis of Grade I or II