Statistical Analysis Battery for Epidemiological Research |
SABER |
Clinical Trial: Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
This study is currently recruiting patients.
Verified by State University of New York - Upstate Medical University September 2005
|
Purpose
| Condition | Intervention |
|---|---|
| Spinal fusion Lumbar discectomy | Procedure: Radiostereometric Analysis beads inserted during surgery |
MedlinePlus consumer health information
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study
Official Title: Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery
Expected Total Enrollment: 75
Study start: October 2002
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
Inclusion Criteria:
- Patients undergoing Spinal fusion or discectomy
Exclusion Criteria:
- pregnant women
Location and Contact Information
New York
SUNY Upstate Medical University, Syracuse, New York, 13202, United States; Recruiting
Nathaniel Ordway, MS, PE 315-464-6462 ordwayn@upstate.edu
Bruce E. Fredrickson, MD, Principal Investigator
Nathaniel Ordway, MS, PE, Sub-Investigator
Amir H Fayyazi, MD, Sub-Investigator
Hansen A Yuan, MD, Sub-Investigator
Bruce E. Fredrickson, MD, Principal Investigator, State University of New York - Upstate Medical University
More Information
Last Updated: September 8, 2005
Record first received: September 8, 2005
ClinicalTrials.gov Identifier: NCT00152152
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-09-13

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