A Pivotal Study Comparing Two Injections of MONOVISC to Two Injections of Saline in Patients With Osteoarthritis of the Hip
Phase: PHASE3
Conditions: Osteoarthritis of the Hip
Sponsor: DePuy Mitek

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Table of Contents 

1.0 
STUDY SUMMARY ........................................................................... 6 
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2.0 
INTRODUCTION ............................................................................. 9 
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2.1.1 
Hyaluronic Acid Therapy for Hip Osteoarthritis
 
9 
3.0 
BENEFITS / RISKS ........................................................................ 10 
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4.0 
Objectives and Hypotheses .......................................................... 12 
5.0 
Study Device ................................................................................. 12 
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5.2.1 
Hyaluronic Acid
 
13 
6.0 
Study Design ................................................................................ 13 
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7.0 
STUDY POPULATION .................................................................... 16 
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8.0 
Study Procedures ......................................................................... 17 
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8.5.1 
Randomization & Injection
 
19 
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9.0 
ADVERSE EVENT REPORTING ....................................................... 22 
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10.0 
EARLY DISCONTINUATION ........................................................ 24 
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11.0 
STATISTICAL METHODOLOGY / DATA MANAGEMENT .............. 25 
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12.0 
STUDY MANAGEMENT AND ADMINISTRATION ......................... 32 
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12.1.1 
Blinded Investigator
 
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12.1.2 
Injecting Investigator
 
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12.1.3 
Clinical Research Coordinator (CRC)
 
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13.0 
SPONSOR OBLIGATIONS ........................................................... 35 
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14.0 
INSTITUTIONAL REVIEW BOARDS AND REGULATORY 
REQUIREMENTS ................................................................................. 36 
 
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15.0 
PUBLICATION POLICY ............................................................... 38 

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16.0 
DEVICES ..................................................................................... 38 
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17.0 
APPENDIX A:  Definitions........................................................... 40 
18.0 
APPENDIX B:  References .......................................................... 41 
19.0 
APPENDIX C: Image guided hip injection technique ................ 42 
20.0 
APPENDIX D:  INFORMED CONSENT FORM ............................... 44 
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