InFUSE™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065

1/14/02


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Table of Contents

InFUSE™ Bone Graft / LT-CAGE ™ Lumbar Tapered Fusion Device IDE Clinical Results G960065

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InFUSE™Bone Graft versus Autograft Harvested from Iliac Crest

Clinical Trial Results

Clinical Trial Design Open Surgical Approach

Study Objectives

Study Entrance Criteria

Patient Evaluation

Patient Population

Demographic Information

Surgery Data

Study Results Based on 24-Month Data

Overall Success

Overall Success Rates

Achieved Primary Objective

Safety Overview

Adverse Events

Adverse Events

Comparison of Adverse Events in Investigational and Control Treatment Groups

Differences noted in:

Adverse Events

Second Surgery Procedures

Classifications

Classifications

Second Surgeries

Assessment of Antibody Formation

Comparision of Authentic Positive Responses Similar for both groups

Safety Summary

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Effectiveness Overview InFUSE™ Bone Graft / LT-CAGE™ Device patients had:

Fusion

Fusion Criteria

Fusion Success Rates

Oswestry Low Back Pain Disability Questionnaire

Mean Oswestry Scores

Oswestry Success 15 Point Improvement

Neurological Status Measurements

Neurological Success Rates

Secondary Effectiveness Endpoints

Back Pain Results - 24 Months

Graft Site Pain in Control Patients Mean Scores

Graft Site Appearance in Control Patients

Use of InFUSE™Bone Graft eliminates:

Laparoscopic Clinical Trial

Surgery Data - Laparoscopic

Overall Success Rates - Laparoscopic Study

Safety Results - Comparable to Open Surgical Treatment Group

Laparoscopic Versus Control 24 Months

Fusion Success Rates - Laparoscopic Study

Case Histories

Control Treatment Group

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Control Treatment Group

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Open Surgical Approach InFUSE™ Treatment Group

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Open Surgical Approach InFUSE™ Treatment Group

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As demonstrated in animal and human studies: CT scans most practical and definitive method for detecting bone formation and determining fusion.

Patient Satisfaction - 24 Months

Conclusions Open Surgical Approach Clinical Trial

Important Benefits of InFUSE™ Bone Graft / LT-CAGE™ Lumbar Tapered Fusion Device

Conclusions - Laparoscopic Surgical Approach Clinical Trial

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