TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/4/2018 |
| Start Date: | September 2010 |
| End Date: | December 2016 |
A Prospective Clinical Investigation of the TRIUMPH Lumbar Disc: A Pilot Study
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.
Lumbar Artificial Disc for the treatment of patients who are suffering from Degenerative Disc
Disease (DDD) at one level from L1 to S1.
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
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Memorial Health University Medical Center Memorial University Medical Center (MUMC) is a nonprofit, 622-bed tertiary...
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