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NCT01640977 · ClinicalTrials.gov registry record
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
A clinical trial, sponsored by NuVasive.
- Completed
- Registry status
- 67
- Enrollment target
NCT01640977: Completed study, sponsored by NuVasive.
NCT01640977 is a clinical trial that has completed, run by NuVasive. The registered enrollment target is 67 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640977 has completed, sponsored by NuVasive.
- COMPLETED
- Registry status
- 67 participants
- Enrollment target
Study Summary
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. After this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the MAS (Maximum Access Surgery) PLIF variant was performed. The data from both series of cases will be compiled to identify similarities and differences between the techniques.
Primary Outcome
All complications will be compiled and their incidence and relationship to the product and/or surgical procedure will be tabulated for comparison.
Interventions
- PROCEDURE Open PLIF (posterior lumbar interbody fusion)
- PROCEDURE MAS PLIF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2012-06 |
| Est. Completion | 2014-09 |
What the finished NCT01640977 record still lists
NCT01640977 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 67 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Open PLIF (posterior lumbar interbody fusion) is the first listed.
NCT01640977 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01640977 about?
NCT01640977 is a clinical study titled "A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF". The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open PLIF (posterior lumbar interbody fusion) procedures. Afte...
What is the current status of trial NCT01640977?
This trial is currently completed. The enrollment target is 67 participants. The study started on 2012-06. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01640977?
The interventions under investigation include: Open PLIF (posterior lumbar interbody fusion) (PROCEDURE), MAS PLIF (PROCEDURE).
Who is sponsoring clinical trial NCT01640977?
This trial is sponsored by NuVasive, which has 28 total clinical trials registered on ClinicalTrials.gov.
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