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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