TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01198470|
Recruitment Status : Completed
First Posted : September 10, 2010
Last Update Posted : March 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Lumbar Degenerative Disc Disease||Device: TRIUMPH® Lumbar Artificial Disc||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: TRIUMPH® Artificial Disc
Treatment of degenerative disc disease with the TRIUMPH Lumbar Artificial Disc. This is a non-randomized pilot study with only one arm (no control).
Device: TRIUMPH® Lumbar Artificial Disc
The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
- ODI score [ Time Frame: 24 months ]Improvement of at least 15 points in pain/disability using the Oswestry Disability Index (ODI) score at 24 months compared with the score at baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01198470
|United States, Georgia|
|Memorial Health University Medical Center|
|Savannah, Georgia, United States, 31403|