NCT00775801

Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: AxioMed Spine Corporation · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Degenerative Disc Disease (DDD)

Interventions

Type	Name	Description
DEVICE	FLD	Artificial lumbar disc
DEVICE	Control	Artificial lumbar disc

Timeline

• Start date: 2008-09-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2008-10-20
• Last updated: 2018-01-23

Locations

14 sites across 2 countries: United States, Germany