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NCT02299323 · ClinicalTrials.gov registry record
INDEPENDENCE Spacer for Lumbar Fusion
A clinical trial, sponsored by Globus Medical.
- Completed
- Registry status
- 30
- Enrollment target
NCT02299323: Completed study, sponsored by Globus Medical.
NCT02299323 is a clinical trial that has completed, run by Globus Medical. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299323 has completed, sponsored by Globus Medical.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.
Primary Outcome
Anterior Posterior / Lateral, Flexion-Extension X-rays at every timepoint will be evaluated for signs of fusion, pseudoarthrosis and implant subsidence or migration
Interventions
- DEVICE INDEPENDENCE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-01 |
| Est. Completion | 2016-08 |
What the finished NCT02299323 record still lists
NCT02299323 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which INDEPENDENCE is the first listed.
NCT02299323 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02299323 about?
NCT02299323 is a clinical study titled "INDEPENDENCE Spacer for Lumbar Fusion". The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low ba...
What is the current status of trial NCT02299323?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2012-01. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02299323?
The interventions under investigation include: INDEPENDENCE (DEVICE).
Who is sponsoring clinical trial NCT02299323?
This trial is sponsored by Globus Medical, which has 10 total clinical trials registered on ClinicalTrials.gov.
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