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Clinical Trials/NCT00152152
NCT00152152
Completed
Not Applicable

Use of Radiostereometric Analysis (RSA) for Measuring Spinal Motion Following Lumbar Spinal Surgery

State University of New York - Upstate Medical University1 site in 1 country75 target enrollmentOctober 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Fusion
Sponsor
State University of New York - Upstate Medical University
Enrollment
75
Locations
1
Status
Completed
Last Updated
17 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 2002
End Date
September 2007
Last Updated
17 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
State University of New York - Upstate Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing Spinal fusion or discectomy

Exclusion Criteria

  • pregnant women

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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