TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study

Completed · Not applicable

Conditions studied: Lumbar Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT01198470

Run by

Globus Medical Inc

People needed

20

Starts

2010-09-01

Expected to finish

2016-12-01

Last updated by the study team

2018-10-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Memorial Health University Medical Center — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

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