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NCT00965380 · ClinicalTrials.gov registry record
Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)
A clinical trial, sponsored by Orthofix.
- Completed
- Registry status
- 207
- Enrollment target
NCT00965380: Completed study, sponsored by Orthofix.
NCT00965380 is a clinical trial that has completed, run by Orthofix. The registered enrollment target is 207 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00965380 has completed, sponsored by Orthofix.
- COMPLETED
- Registry status
- 207 participants
- Enrollment target
Study Summary
The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined with an interbody spacer and supplemental posterior fixation will result in fusion rates and clinical outcomes similar to those with other routinely used autograft and allograft materials including: fusion, improvement in pain and function, maintenance of lower extremity neurological function, and absence of serious adverse events related to the use of the Trinity Evolution product.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2009-09 |
| Est. Completion | 2015-01 |
What the finished NCT00965380 record still lists
NCT00965380 is an observational study that tracks outcomes without assigning an intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00965380 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00965380 about?
NCT00965380 is a clinical study titled "Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion (PLIF/TLIF)". The purpose of this study is to utilize Trinity Evolution in conjunction with an interbody spacer and supplemental posterior fixation of the surgeon's choice and to follow the patients to measure the clinical outcomes and rate of fusion. The hypothesis of the study is that Trinity Evolution combined...
What is the current status of trial NCT00965380?
This trial is currently completed. The enrollment target is 207 participants. The study started on 2009-09. Estimated completion is 2015-01.
Who is sponsoring clinical trial NCT00965380?
This trial is sponsored by Orthofix, which has 14 total clinical trials registered on ClinicalTrials.gov.
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