TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Globus Medical Inc

ClinicalTrials.gov Identifier:

NCT01198470

First received: September 8, 2010

Last updated: March 15, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	September 8, 2010
Last Updated Date	March 15, 2013
Start Date ^ICMJE	September 2010
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 8, 2010)	ODI score [ Time Frame: 24 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01198470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Official Title ^ICMJE	A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Lumbar Degenerative Disc Disease
Intervention ^ICMJE	Device: TRIUMPH® Lumbar Artificial Disc The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
Study Arm (s)	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). Intervention: Device: TRIUMPH® Lumbar Artificial Disc
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	October 2013
Estimated Primary Completion Date	October 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01198470
Other Study ID Numbers ^ICMJE	G090143
Has Data Monitoring Committee	No
Responsible Party	Globus Medical Inc
Study Sponsor ^ICMJE	Globus Medical Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Globus Medical Inc
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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