Status:
COMPLETED
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
Lead Sponsor:
Globus Medical Inc
Conditions:
Lumbar Degenerative Disc Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01198470
Start Date
September 1 2010
End Date
December 1 2016
Last Update
October 2 2018
Active Locations (1)
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1
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403