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NCT00152165 · ClinicalTrials.gov registry record
Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System
A clinical trial, sponsored by State University of New York - Upstate Medical University.
- Completed
- Registry status
- 12
- Enrollment target
NCT00152165: Completed study, sponsored by State University of New York - Upstate Medical University.
NCT00152165 is a clinical trial that has completed, run by State University of New York - Upstate Medical University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00152165 has completed, sponsored by State University of New York - Upstate Medical University.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study Summary
Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette device. All subjects will already be participating in the DYNESYS multi-center study (under IRB #4884) and will have been randomized to either group. Five tantalum beads will be inserted into each vertebra associated with the DYNESYS or fusion surgery. Subjects will be followed in conjunction with the multi-center follow-up schedule and will have RSA exams at the following time points after surgery: 3, 6, 12, 18, and 24 months. Standing neutral, flexion, extension, and lateral bending films will be collected at each time point and the amount of motion in each direction of the "marked" vertebrae will be measured. The time points have been selected based on their clinical relevance for comparison against the standard of care, which is the fusion procedure. Depending on the initial tension of the annular fibers, it is possible the DYNESYS will exhibit more motion with time. The time points are important to track the potential changes.
Interventions
- PROCEDURE Radiostereometric Analysis beads inserted during surgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2003-11 |
What the finished NCT00152165 record still lists
NCT00152165 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Radiostereometric Analysis beads inserted during surgery is the first listed.
NCT00152165 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00152165 about?
NCT00152165 is a clinical study titled "Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System". Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette device. All subjects will already be participating in the DYNESYS multi-center study (under IRB #4884) and will hav...
What is the current status of trial NCT00152165?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2003-11.
What interventions are being tested in trial NCT00152165?
The interventions under investigation include: Radiostereometric Analysis beads inserted during surgery (PROCEDURE).
Who is sponsoring clinical trial NCT00152165?
This trial is sponsored by State University of New York - Upstate Medical University, which has 113 total clinical trials registered on ClinicalTrials.gov.
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