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


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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

Sponsors and Collaborators: State University of New York - Upstate Medical University
DePuy-Acromed, Inc.
Information provided by: State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00152152

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

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

Further Study Details: 

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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients undergoing Spinal fusion or discectomy

Exclusion Criteria:

  • pregnant women

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00152152


New York
      SUNY Upstate Medical University, Syracuse,  New York,  13202,  United States; Recruiting
Tina M Craig  315-464-8618    craigt@upstate.edu 
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

Study chairs or principal investigators

Bruce E. Fredrickson, MD,  Principal Investigator,  State University of New York - Upstate Medical University   

More Information

Study ID Numbers:  SUNY UMU IRB# 4715
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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Page Updated: November 22, 2004
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