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Effect of Intra-Articular Triamcinolone Vs Saline on Knee

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Effect of Intra-Articular Triamcinolone Vs Saline on Knee Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Downloaded From: https://jamanetwork.com/ on 09/28/2021 Protocol Effect of Intra-Articular Steroids on Structural Title: Progression of Knee OA: A Randomized Controlled Trial Protocol Version Date: April 15, 2014 (Protocol changes) May 2, 2012 (Protocol changes) February 29, 2012 (Protocol changes) August 3, 2011 (Protocol changes) April 11, 2011 (Protocol changes) February 16, 2011 (DSMB requested changes) October 8, 2010 (DSMB requested changes) June 29, 2010 (IRB requested changes) June 18, 2010 (IRB requested changes) April 12, 2010 (Initial) Principal Timothy E. McAlindon, MD, MPH Investigator: Chief, Division of Rheumatology Tufts Medical Center 800 Washington Street, Tufts Box 406 Boston, MA 02111 NIAMS Grant: R01 AR057802-01 ________________________________________________________________________________________________ NIAMS grant # R01 AR057802-01 Version April 15, 2014 (replaces Version May 2, 2012) Page 1 of 65 Downloaded From: https://jamanetwork.com/ on 09/28/2021 TABLE of CONTENTS ABBREVIATIONS ............................................................................................... 5 1. SUMMARY .................................................................................................... 7 2. BACKGROUND AND SIGNIFICANCE ............................................................ 7 2.1 OSTEOARTHRITIS BACKGROUND.............................................................................. 7 2.2 KNEE OSTEOARTHRITIS AND KNEE SYNOVITIS ........................................................... 7 2.3 MECHANISMS OF JOINT DAMAGE FROM SYNOVITIS IN KNEE OSTEOARTHRITIS ................ 8 2.4 IACS: CURRENT CLINICAL USAGE IN THE TREATMENT OF KNEE OSTEOARTHRITIS ........... 9 2.5 EFFECTIVENESS OF IACS FOR KNEE OSTEOARTHRITIS PAIN ........................................ 9 2.6 PREVIOUS STUDIES EVALUATING THE EFFECT OF IACS IN CLINICAL SAMPLES ................ 9 2.7 ARE INTRA-ARTICULAR CORTICOSTEROIDS SAFE? ................................................... 10 2.8 EFFECTS OF INTRA-ARTICULAR CORTICOSTEROIDS ON CARTILAGE .............................. 10 2.9 EFFECTS OF CORTICOSTEROIDS ON HEALTHY CARTILAGE IN-VITRO ............................. 11 2.10 EFFECTS OF CORTICOSTEROIDS ON HEALTHY CARTILAGE IN ANIMAL MODELS ............... 11 2.11 EFFECTS OF CORTICOSTEROIDS ON DEGENERATIVE CARTILAGE IN ANIMAL MODELS ....... 11 2.12 EFFECTS OF CORTICOSTEROIDS ON CARTILAGE DAMAGE IN ANIMAL MODELS ................ 12 2.13 INTRA-ARTICULAR CORTICOSTEROIDS AND PERI-ARTICULAR BONE ............................ 12 2.14 ULTRASONOGRAPHIC SCREENING FOR SYNOVITIS IN OSTEOARTHRITIC KNEES .............. 13 2.15 MRI ASSESSMENT OF SYNOVITIS IN OSTEOARTHRITIC KNEES .................................... 14 2.16 MRI IN THE ASSESSMENT OF KNEE OA STRUCTURAL PROGRESSION ............................ 14 2.17 PERI-ARTICULAR TRABECULAR MORPHOMETRY IN KNEE OA USING MRI ..................... 15 3. STUDY OBJECTIVES................................................................................... 15 4. INVESTIGATION SITES ............................................................................. 16 5. DURATION OF STUDY ................................................................................ 16 6. STUDY SAMPLE .......................................................................................... 16 6.1 NUMBER OF STUDY PARTICIPANTS ........................................................................ 16 6.2 PRIMARY DIAGNOSIS .......................................................................................... 16 6.3 INCLUSION CRITERIA .......................................................................................... 16 6.4 EXCLUSION CRITERIA.......................................................................................... 16 6.5 SELECTION OF THE STUDY KNEE IN THE EVENT THAT BOTH ARE ELIGIBLE .................... 17 7. STUDY INTERVENTION ............................................................................. 17 7.1 INVESTIGATIONAL PRODUCT ................................................................................ 17 7.2 PLACEBO PRODUCT ............................................................................................. 17 7.3 INVESTIGATIONAL PRODUCT AND PLACEBO STORAGE ................................................ 19 7.4 INVESTIGATIONAL PRODUCT AND PLACEBO PREPARATION ......................................... 19 7.5 INVESTIGATIONAL PRODUCT DOSAGE AND ADMINISTRATION ..................................... 19 7.6 INVESTIGATIONAL MODE OF MEDICAL DEVICE ......................................................... 19 7.7 DURATION OF TREATMENT ................................................................................... 19 7.8 WARNINGS AND PRECAUTIONS ............................................................................. 19 ________________________________________________________________________________________________ NIAMS grant # R01 AR057802-01 Version April 15, 2014 (replaces Version May 2, 2012) Page 2 of 65 Downloaded From: https://jamanetwork.com/ on 09/28/2021 7.8.1 Triamcinolone ............................................................................................................... 19 7.8.2 0.9% Sodium Chloride (placebo) .................................................................................... 20 7.8.3 MRIs and Women of Child Bearing Potential .................................................................... 20 7.8.4 Uncontrolled HIV Infection .............................................................................................. 20 8. PROCEDURES AND MONITORING ............................................................. 21 8.1 RANDOMIZATION................................................................................................ 21 8.2 GOOD CLINICAL PRACTICE (GCP) AND MONITORING ............................................... 21 8.3 ELECTRONIC DATA CAPTURE ................................................................................. 21 8.3.1 Security of the Electronic Data ....................................................................................... 21 8.3.2 HIPAA .......................................................................................................................... 22 8.4 CONSENTS ......................................................................................................... 22 8.4.1 Informed Consent ......................................................................................................... 22 8.4.2 Research Authorization Form ......................................................................................... 22 8.4.3 E-Mail .......................................................................................................................... 22 8.4.4 Photography/Video-Recording ........................................................................................ 23 8.4.5 Optional Tissue Banking
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