Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System
Completed
Conditions studied: Spinal Fusion, Orthopedic Procedures
In brief
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.
Key facts
- Study ID
- NCT00152165
- Run by
- State University of New York - Upstate Medical University
- People needed
- 12
- Starts
- 2003-11-01
- Last updated by the study team
- 2008-12-02
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing spinal fusion
- Patients undergoing spinal surgery with DYNESYS Stabilization System
You may not qualify if…
- Pregnant women
Where it is running
- Institute for Human Performance — Syracuse, New York, United States
Full record on ClinicalTrials.gov
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