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Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease — FLD  

Degenerative Disc Disease (DDD) Clinical Trial

Official title:
An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

Clinical Trial Summary

This study will look at the result of using the FLD device as an artificial lumbar disc. The study will compare the safety and effectiveness of the FLD artificial lumbar disc to an already approved artificial lumbar disc.

Clinical Trial Description

The Freedom Lumbar Disc is indicated for spinal arthroplasty in skeletally mature patients with single level, symptomatic degenerative disc disease (DDD) from L3-S1. This is a prospective, multi-center, randomized, controlled trial. Subjects with DDD will be randomized to disc arthroplasty with the FLD device or a control device. The overall purpose (objective) of this trial is to collect clinical data to demonstrate the safety and effectiveness of FLD used for the treatment of symptomatic lumbar degenerative disc disease compared to the control device. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00775801
Study type Interventional
Source AxioMed Spine Corporation
Contact
Status Active, not recruiting
Phase N/A
Start date September 2008
Completion date July 2018
View Details
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