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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

September 8, 2005
May 22, 2008
October 2002
September 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00152152 on ClinicalTrials.gov Archive Site
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Use of Radiostereometric Analysis Beads (RSA) to Measure Motion in the Spine, Following Lumbar Spinal Surgery
Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery

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.

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.

Observational
Time Perspective: Prospective
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  • Spinal Fusion
  • Lumbar Discectomy
Procedure: Radiostereometric Analysis beads inserted during surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
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September 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing Spinal fusion or discectomy

Exclusion Criteria:

  • pregnant women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00152152
SUNY UMU IRB# 4715
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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
State University of New York - Upstate Medical University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP