TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
|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.
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|