Use of Radiostereometric Analysis (RSA) Following Spinal Fusion Versus the DYNESYS Stabilization System

NCT00152165 | Completed

• 1 other identifier: SUNY UMU IRB# 4895
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Twelve subjects will be sought for this study. Six subjects will receive the DYNESYS system and six subjects will receive a posterior lumbar interbody fusion (PLIF) with the Silhouette device. All subjects will already be participating in the DYNESYS multi-center study (under IRB #4884) and will have been randomized to either group. Five tantalum beads will be inserted into each vertebra associated with the DYNESYS or fusion surgery. Subjects will be followed in conjunction with the multi-center follow-up schedule and will have RSA exams at the following time points after surgery: 3, 6, 12, 18, and 24 months. Standing neutral, flexion, extension, and lateral bending films will be collected at each time point and the amount of motion in each direction of the "marked" vertebrae will be measured. The time points have been selected based on their clinical relevance for comparison against the standard of care, which is the fusion procedure. Depending on the initial tension of the annular fibers, it is possible the DYNESYS will exhibit more motion with time. The time points are important to track the potential changes.

Conditions

Spinal Fusion; Orthopedic Procedures

Keywords

spinal motion; tantalum beads; DYNESYS Stabilization system; spinal fusion; Radiostereometric Analysis following spinal fusion; Radiostereometric Analysis following surgery with DYNESYS Stabilization System

Interventions

Radiostereometric Analysis beads inserted during surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing spinal fusion
• Patients undergoing spinal surgery with DYNESYS Stabilization System

You may not qualify if:

• Pregnant women

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Institute for Human Performance

Syracuse, New York, 13202, United States

Location

Study Officials

• Nathaniel Ordway, MS, PE

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 9, 2005
• Study Start: November 1, 2003
• Last Updated: December 2, 2008

Record last verified: 2008-12

Locations

US (1)