Clinical Review

1/14/02


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Table of Contents

Clinical Review

Clinical Review

Clinical Summary

Clinical Review

Clinical Endpoints

Accountability at 24 months Randomized Patients

Results Equivalent Findings

Results Intraoperative

Results Antibody Testing

Results Antibody Testing

Results Antibody Testing

Results Other Effectiveness Endpoints

Conclusions Primary Effectiveness Endpoints

Conclusions Secondary Effectiveness Endpoints

Results Adverse Events

Results Adverse Event Rates

Results Adverse Events

Results Adverse Events

Device Related Events

Device Related Events

Results Second Surgeries

Clinical Conclusions

Radiographic Interpretation

Radiographic Interpretation

Radiographic Interpretation

Radiographic success Fusion

Radiographic interpretation Xray vs. CT scan

6 month CT Success

12 Month CT Success

24 Month CT Success

6 Month CT Failure

12 Month CT Failure

24 Month CT Failure

Radiographic interpretation X-ray vs. CT scan

Radiographic interpretation X-ray vs. CT scan

Radiographic Interpretation Xrays vs. CT scans

Radiographic Interpretation Issues to consider

Author: Aric Kaiser