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

This study has been completed.
Sponsor:
Collaborator:
DePuy-Acromed, Inc.
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00152152
First received: September 8, 2005
Last updated: May 22, 2008
Last verified: May 2008
  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

Further study details as provided by State University of New York - Upstate Medical University:

Estimated Enrollment: 75
Study Start Date: October 2002
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Spinal fusion or discectomy

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00152152

Locations
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.
Investigators
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 October 30, 2014