Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
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Purpose
Radiostereometric Analysis (RSA) is a new imaging technique used to measure motions in the spine. It provides more accurate measurements that could help in diagnosing problems in the spine earlier than standard xray techniques.
| Condition | Intervention |
|---|---|
|
Spinal Fusion Lumbar Discectomy |
Procedure: Radiostereometric Analysis beads inserted during surgery |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery |
| Estimated Enrollment: | 75 |
| Study Start Date: | October 2002 |
| Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Assessment of segmental spinal motion has been and continues to be a difficult clinical problem. X-ray measurement error of up to 10 degrees for simple measurements for flexion, extension and side bending have been recorded. It is extremely difficult to measure small changes in vertebral alignment that may prove to have clinical significance. The measurement accuracy of the RSA technique far exceeds any manual techniques to date. RSA allows the surgeon to monitor spatial relationships within the spine over time with a much higher accuracy then conventional techniques.
This is a non-randomized prospective study design looking at the use of RSA in spinal surgery patients. Subjects in this study will undergo their indicated surgery. Prior to closure, they will be implanted with tantalum beads, which will serve as landmarks when the RSA film pairs are taken post-operatively. The subjects will have standard post-operative x-rays 6 weeks-3 months post-op and again at 12 months post-op. Yearly visits after this are anticipated for 5-10 years with proper funding.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing Spinal fusion or discectomy
Exclusion Criteria:
- pregnant women
Contacts and Locations| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13202 | |
| Principal Investigator: | Bruce E. Fredrickson, MD | State University of New York - Upstate Medical University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00152152 History of Changes |
| Other Study ID Numbers: | SUNY UMU IRB# 4715 |
| Study First Received: | September 8, 2005 |
| Last Updated: | May 22, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by State University of New York - Upstate Medical University:
|
spinal motion tantalum beads |
ClinicalTrials.gov processed this record on May 16, 2013