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Sponsored by: |
AxioMed Spine Corporation |
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Information provided by: | AxioMed Spine Corporation |
ClinicalTrials.gov Identifier: | NCT00775801 |
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.
Condition | Intervention |
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Degenerative Disc Disease (DDD) |
Device: FLD Device: Control |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An IDE Study of the Freedom Lumbar Disc in the Treatment of Lumbar Degenerative Disc Disease |
Estimated Enrollment: | 300 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
FLD
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Device: FLD
Artificial lumbar disc
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Control: Active Comparator |
Device: Control
Artificial lumbar disc
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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.
Ages Eligible for Study: | 21 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Burkhard Rischke, Dr. Med. | 49016090716123 | b-rischke@hamburg.de |
Germany | |
Westend Hospital | Recruiting |
Berlin, Germany, 14050 | |
Principal Investigator: Burkhard Rischke, Dr. Med. |
Principal Investigator: | Burkhard Rischke, Dr. Med. | Westend Hospital |
Responsible Party: | AxioMed Spine Corporation ( Neal Defibaugh, Vice President Clinical and Regulatory Affairs ) |
Study ID Numbers: | PR-125 |
Study First Received: | October 13, 2008 |
Last Updated: | October 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00775801 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; United States: Food and Drug Administration |
Spinal Diseases Musculoskeletal Diseases Bone Diseases |