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NCT01198470 · ClinicalTrials.gov registry record · NA
TRIUMPH Lumbar Artificial Disc IDE: A Pilot Study
A NA study, sponsored by Globus Medical.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01198470: Completed NA study, sponsored by Globus Medical.
NCT01198470 is a NA study that has completed, run by Globus Medical. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01198470, a NA study, has completed, sponsored by Globus Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study 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.
Primary Outcome
The Oswestry Disability Index (ODI) is a commonly used outcome-measure questionnaire for low back pain in a hospital setting. It is a self-administered questionnaire divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale, 5 representing the greatest disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is th
Interventions
- DEVICE TRIUMPH® Lumbar Artificial Disc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2010-09 |
| Est. Completion | 2016-12 |
| Phase | NA |
What the finished NCT01198470 record still lists
NCT01198470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which TRIUMPH® Lumbar Artificial Disc is the first listed.
NCT01198470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01198470 about?
NCT01198470 is a clinical study titled "TRIUMPH Lumbar Artificial Disc IDE: 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.
What is the current status of trial NCT01198470?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2010-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01198470?
The interventions under investigation include: TRIUMPH® Lumbar Artificial Disc (DEVICE).
Who is sponsoring clinical trial NCT01198470?
This trial is sponsored by Globus Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01198470's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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