TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
This trial is active, not recruiting.
|Condition||lumbar degenerative disc disease|
|Treatment||triumph® lumbar artificial disc|
|Sponsor||Globus Medical Inc|
|Start date||September 2010|
|End date||October 2016|
|Trial size||50 participants|
|Trial identifier||NCT01198470, G090143|
The purpose of this investigation is to evaluate the safety and effectiveness of the TRIUMPH® Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc Disease (DDD) at one level from L1 to S1.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: 24 months
Male or female participants from 18 years up to 65 years old.
Inclusion Criteria: - Degenerative Disc Disease in one vertebral level between L1 and S1 - Able to understand and sign informed consent - Had at least 6 months of conservative treatment - Oswestry Disability Index Score of at least 30 (one a 100 point scale) - Other inclusion criteria as specified in approved IDE protocol Exclusion Criteria: - Bilateral leg pain - Back or leg pain of unknown etiology - Prior fusion surgery or another spinal device implanted at any other lumbar level - Osteoporosis or osteopenia - Other exclusion criteria as specified in approved IDE protocol
|Official title||A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study|
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