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Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery

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ClinicalTrials.gov Identifier: NCT00152152
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : May 23, 2008
DePuy-Acromed, Inc.
Information provided by:
State University of New York - Upstate Medical University

Brief Summary:
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 or disease Intervention/treatment
Spinal Fusion Lumbar Discectomy Procedure: Radiostereometric Analysis beads inserted during surgery

Detailed Description:

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.

Study Type : Observational
Estimated Enrollment : 75 participants
Time Perspective: Prospective
Official Title: Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery
Study Start Date : October 2002
Primary Completion Date : September 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients undergoing Spinal fusion or discectomy

Exclusion Criteria:

  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00152152

United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13202
Sponsors and Collaborators
State University of New York - Upstate Medical University
DePuy-Acromed, Inc.
Principal Investigator: Bruce E. Fredrickson, MD State University of New York - Upstate Medical University

ClinicalTrials.gov Identifier: NCT00152152     History of Changes
Other Study ID Numbers: SUNY UMU IRB# 4715
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

Keywords provided by State University of New York - Upstate Medical University:
spinal motion
tantalum beads