MedTrace Logo

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

NCT00152165 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2008-12-02

No results posted yet for this study

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

Interventions

PROCEDURE

Radiostereometric Analysis beads inserted during surgery

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Nathaniel Ordway, MS, PE · State University of New York - Upstate Medical University

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00152165 on ClinicalTrials.gov