TREATMENT OF OSTEOARTHRITIS OF THE KNEE EVIDENCE-BASED GUIDELINE ND 2 EDITION Adopted by the American Academy of Orthopaedic Surgeons Board of Directors May 18, 2013 i Disclaimer This clinical practice guideline was developed by an AAOS work group comprised of volunteer physicians and interdisciplinary clinicians as well as staff researchers with expertise in systematic reviews and statistical methods used to evaluate empirical evidence. It is an educational tool that integrates the current scientific literature and the proficiency and sound judgment that physicians typically acquire in clinical practice. The recommendations that make up this guideline are not intended to be absolute as patients vary in how they experience symptoms and respond to treatment interventions. There may be variability between patients in practice and those who participate in clinical trials. Medical care should always be based on a physician’s expertise that is individually tailored to the patient’s circumstances, preferences and rights. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to this clinical practice guideline provided full disclosure of and were vetted for potential conflicts of interest prior to the introductory meeting. Funding Source The American Academy of Orthopaedic Surgeons funded this clinical practice guideline without any financial support from outside commercial sources. FDA Clearance Some drugs or medical devices referenced or described in this clinical practice guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the clearance status of each drug or device prescribed in clinical practice. Copyright All rights reserved. No part of this clinical practice guideline may be reproduced or stored in a retrieval system or transmitted in any form or by any means (electronic, mechanical, photocopying, recording, or otherwise) without prior written permission from the AAOS. Published 2013 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018 Second Edition Copyright 2013 by the American Academy of Orthopaedic Surgeons ii TABLE OF CONTENTS Table of Contents ............................................................................................................... iii List of Tables ..................................................................................................................... ix List of Figures ................................................................................................................... xv Summary of Recommendations .......................................................................................... 1 Conservative Treatments: Recommendations 1-6 .............................................................. 1 Recommendation 1 ......................................................................................................... 1 Recommendation 2 ......................................................................................................... 1 Recommendation 3a........................................................................................................ 2 Recommendation 3b ....................................................................................................... 2 Recommendation 3c........................................................................................................ 2 Recommendation 4 ......................................................................................................... 2 Recommendation 5 ......................................................................................................... 3 Recommendation 6 ......................................................................................................... 3 Pharmacologic Treatments: Recommendation 7 ................................................................ 3 Recommendation 7a........................................................................................................ 3 Recommendation 7b ....................................................................................................... 4 Procedural Treatments: Recommendations 8-11 ................................................................ 4 Recommendation 8 ......................................................................................................... 4 Recommendation 9 ......................................................................................................... 4 Recommendation 10 ....................................................................................................... 5 Recommendation 11 ....................................................................................................... 5 Surgical Treatments: Recommendations 12-15 .................................................................. 5 Recommendation 12 ....................................................................................................... 5 Recommendation 13 ....................................................................................................... 5 Recommendation 14 ....................................................................................................... 6 Recommendation 15 ....................................................................................................... 6 Introduction ......................................................................................................................... 7 Overview ......................................................................................................................... 7 Goals and Rationale ........................................................................................................ 7 Intended Users ................................................................................................................ 7 Patient Population ........................................................................................................... 8 Scope ............................................................................................................................... 8 Etiology ........................................................................................................................... 8 Incidence and Prevalence ................................................................................................ 8 Burden of Disease ........................................................................................................... 9 Emotional and Physical Impact ...................................................................................... 9 Potential Benefits, Harm, and Contraindications ............................................................ 9 Differences Between the Present and Previous Guidelines ............................................ 9 Preventing Bias in an AAOS Clinical Practice Guideline ................................................ 11 Methods............................................................................................................................. 14 Formulating Preliminary Recommendations ................................................................ 14 Full Disclosure Information .......................................................................................... 14 Study Selection Criteria ................................................................................................ 14 Best Evidence Synthesis ............................................................................................... 15 Outcomes Considered ................................................................................................... 16 iii Literature Searches........................................................................................................ 16 Appraising Evidence Quality and Applicability ........................................................... 16 Quality....................................................................................................................... 16 Applicability .............................................................................................................. 18 Minimum Clinically Important Improvement .............................................................. 18 Grade of Recommendation ........................................................................................... 19 Defining the Strength of the Recommendations ........................................................... 20 Wording of the Final Recommendations ...................................................................... 20 Consensus Recommendations ....................................................................................... 22 Voting on the Recommendations .................................................................................. 22 Statistical Methods ........................................................................................................ 23 Network Meta-Analysis ............................................................................................ 23 Placebo Data Regression Analysis............................................................................ 24 Inclusion Criteria .................................................................................................. 24 Statistical Analysis ................................................................................................ 24 Results ................................................................................................................... 25 New To Meta-Analysis In This Guideline: Minimal Important Difference (MID) Units .......................................................................................................................... 25 Peer Review .................................................................................................................. 26 Public Comment............................................................................................................ 27 The AAOS Guideline Approval Process ...................................................................... 28 Revision Plans ............................................................................................................... 28 Guideline Dissemination Plans ..................................................................................... 28 AAOS Clinical Guideline on Treating Osteoarthritis of the Knee ................................... 31 Guideline Recommendations ............................................................................................ 31 Recommendation 1 ....................................................................................................... 31 Rationale ................................................................................................................... 31 Supporting Evidence ................................................................................................. 32 Quality................................................................................................................... 32 Applicability ......................................................................................................... 34 Final Strength of Evidence.................................................................................... 35 Results ................................................................................................................... 46 Evidence Tables and Figures .................................................................................... 61 Quality and Applicability ...................................................................................... 61 Findings................................................................................................................. 98 Recommendation 2 ..................................................................................................... 138 Rationale ................................................................................................................. 138 Supporting Evidence ............................................................................................... 138 Quality................................................................................................................. 138 Applicability ....................................................................................................... 139 Final Strength of Evidence.................................................................................. 139 Results ................................................................................................................. 141 Evidence Tables and Figures .................................................................................. 146 Quality and Applicability .................................................................................... 146 Findings............................................................................................................... 152 Recommendation 3a.................................................................................................... 159 iv Recommendation 3b ................................................................................................... 159 Recommendation 3c.................................................................................................... 159 Rationale ................................................................................................................. 159 Supporting Evidence ............................................................................................... 161 Quality................................................................................................................. 161 Applicability ....................................................................................................... 162 Final Strength of Evidence.................................................................................. 162 Results ................................................................................................................. 170 Evidence Tables and Figures .................................................................................. 177 Quality and Applicability .................................................................................... 177 Findings............................................................................................................... 201 Recommendation 4 ..................................................................................................... 228 Rationale ................................................................................................................. 228 Supporting Evidence ............................................................................................... 228 Quality................................................................................................................. 228 Applicability ....................................................................................................... 228 Final Strength of Evidence.................................................................................. 229 Results ................................................................................................................. 230 Evidence Tables and Figures .................................................................................. 234 Quality and Applicability .................................................................................... 234 Findings............................................................................................................... 241 Recommendation 5 ..................................................................................................... 249 Rationale ................................................................................................................. 249 Supporting Evidence ............................................................................................... 249 Quality................................................................................................................. 249 Applicability ....................................................................................................... 249 Final Strength of Evidence.................................................................................. 250 Results ................................................................................................................. 251 Evidence Tables and Figures .................................................................................. 253 Quality and Applicability .................................................................................... 253 Findings............................................................................................................... 256 Recommendation 6 ..................................................................................................... 262 Rationale ................................................................................................................. 262 Supporting Evidence ............................................................................................... 263 Quality................................................................................................................. 263 Applicability ....................................................................................................... 263 Final Strength of Evidence.................................................................................. 263 Results ................................................................................................................. 273 Evidence Tables and Figures .................................................................................. 279 Quality and Applicability .................................................................................... 279 Findings............................................................................................................... 306 Recommendation 7a.................................................................................................... 342 Recommendation 7b ................................................................................................... 342 Rationale ................................................................................................................. 342 Supporting Evidence ............................................................................................... 343 Quality................................................................................................................. 343 v Applicability ....................................................................................................... 343 Final Strength of Evidence.................................................................................. 344 Results ................................................................................................................. 429 Evidence Tables and Figures .................................................................................. 441 Quality and Applicability .................................................................................... 441 Findings............................................................................................................... 624 Recommendation 8 ..................................................................................................... 747 Rationale ................................................................................................................. 747 Supporting Evidence ............................................................................................... 747 Quality................................................................................................................. 747 Applicability ....................................................................................................... 748 Final Strength of Evidence.................................................................................. 748 Results ................................................................................................................. 752 Evidence Tables and Figures .................................................................................. 754 Quality and Applicability .................................................................................... 754 Findings............................................................................................................... 762 Recommendation 9 ..................................................................................................... 770 Rationale ................................................................................................................. 770 Supporting Evidence ............................................................................................... 771 Quality................................................................................................................. 771 Applicability ....................................................................................................... 771 Final Strength of Evidence.................................................................................. 772 Results ................................................................................................................. 783 Evidence Tables and Figures .................................................................................. 789 Quality and Applicability .................................................................................... 789 Findings............................................................................................................... 813 Recommendation 10 ................................................................................................... 854 Rationale ................................................................................................................. 854 Supporting Evidence ............................................................................................... 854 Quality................................................................................................................. 854 Applicability ....................................................................................................... 854 Final Strength of Evidence.................................................................................. 855 Results ................................................................................................................. 856 Evidence Tables and Figures .................................................................................. 857 Quality and Applicability .................................................................................... 857 Findings............................................................................................................... 860 Recommendation 11 ................................................................................................... 863 Rationale ................................................................................................................. 863 Supporting Evidence ............................................................................................... 863 Quality................................................................................................................. 863 Applicability ....................................................................................................... 864 Final Strength of Evidence.................................................................................. 864 Results ................................................................................................................. 865 Evidence Tables and Figures .................................................................................. 867 Quality and Applicability .................................................................................... 867 Findings............................................................................................................... 871 vi Recommendation 12 ................................................................................................... 876 Rationale ................................................................................................................. 876 Supporting Evidence ............................................................................................... 877 Quality................................................................................................................. 877 Applicability ....................................................................................................... 877 Final Strength of Evidence.................................................................................. 877 Results ................................................................................................................. 887 Evidence Tables and Figures .................................................................................. 889 Quality and Applicability .................................................................................... 889 Findings............................................................................................................... 913 Recommendation 13 ................................................................................................... 932 Rationale ................................................................................................................. 932 Supporting Evidence ............................................................................................... 932 Quality................................................................................................................. 932 Applicability ....................................................................................................... 932 Final Strength of Evidence.................................................................................. 932 Results ................................................................................................................. 934 Evidence Tables and Figures .................................................................................. 935 Quality and Applicability .................................................................................... 935 Findings............................................................................................................... 937 Recommendation 14 ................................................................................................... 939 Rationale ................................................................................................................. 939 Supporting Evidence ............................................................................................... 939 Quality................................................................................................................. 939 Applicability ....................................................................................................... 939 Final Strength of Evidence.................................................................................. 940 Results ................................................................................................................. 945 Evidence Tables and Figures .................................................................................. 946 Quality and Applicability .................................................................................... 946 Findings............................................................................................................... 956 Recommendation 15 ................................................................................................... 969 Rationale ................................................................................................................. 969 Supporting Evidence ............................................................................................... 969 Quality................................................................................................................. 969 Applicability ....................................................................................................... 969 Final Strength of Evidence.................................................................................. 970 Results ................................................................................................................. 970 Evidence Tables and Figures .................................................................................. 971 Quality and Applicability .................................................................................... 971 Findings............................................................................................................... 972 Future Research .......................................................................................................... 974 Appendix I .................................................................................................................. 976 Work Group ............................................................................................................ 976 Revision Work Group ............................................................................................. 976 Original Work Group .............................................................................................. 978 Appendix II ................................................................................................................. 980 vii Decision-Makers Who Approve This Clinical Practice Guideline ......................... 980 Appendix III ................................................................................................................ 981 Determining Critical Outcomes .................................................................................. 981 Work Group Participation ....................................................................................... 981 Critical Outcomes Form .......................................................................................... 981 Determining Outcomes ....................................................................................... 981 Appendix IV................................................................................................................ 985 Study Attrition Flowchart ....................................................................................... 985 Appendix V ................................................................................................................. 986 Literature Search Strategies .................................................................................... 986 PubMed/MEDLINE ............................................................................................ 986 Embase ................................................................................................................ 988 Cochrane Library (Wiley Interface).................................................................... 990 Appendix VI................................................................................................................ 992 Quality and Applicability Appraisal ....................................................................... 992 Quality..................................................................................................................... 992 Applicability ........................................................................................................... 997 Appendix VII ............................................................................................................ 1000 Form For Assigning Strength of Recommendation .............................................. 1000 Appendix VIII ........................................................................................................... 1001 Opinion Based Recommendations ........................................................................ 1001 Rules for Making Opinion Based Recommendations ........................................... 1001 Checklist For Voting on Opinion Based Recommendations ................................ 1002 Voting by the Nominal Group Technique ............................................................ 1002 Appendix IX.............................................................................................................. 1003 Structured Peer Review Form ............................................................................... 1003 Appendix X ............................................................................................................... 1007 Participating Peer Review Organizations ............................................................. 1007 Appendix XI.............................................................................................................. 1008 Interpreting the Forest Plots .................................................................................. 1008 Abbreviations Used In This Report ...................................................................... 1008 Appendix XII ............................................................................................................ 1010 Conflict of Interest ................................................................................................ 1010 Appendix XIII ........................................................................................................... 1012 Network Meta Analysis Checks for Consistency ................................................. 1012 Appendix XIV ........................................................................................................... 1022 Confidence Intervals of Treatment Effects that Range in Statistical and Clinical Signficance ............................................................................................................ 1022 Appendix XV ............................................................................................................ 1023 Bibliography ......................................................................................................... 1023 Additional References ........................................................................................... 1040 Excluded Studies ................................................................................................... 1051 viii LIST OF TABLES Table 1. Relationship between Quality and Domain Scores for Treatment Studies ......... 17 Table 2. Relationship between Applicability and Domain Scores for Treatment Studies 18 Table 3. Brief Description of the PRECIS Questions and Domains................................. 18 Table 4. Descriptive Terms for Results with MCII .......................................................... 19 Table 5. AAOS Guideline Language ................................................................................ 20 Table 6. Recommendation Strengths, Descriptions, and Clinical Implications ............... 21 Table 7. Quality and Applicability Summary: Strength Training Versus Control ........... 35 Table 8 Quality and Applicability Summary: Isokinetic Versus Isotonic Versus Isometric Strength Training .............................................................................................................. 36 Table 9. Quality and Applicability Summary: High Versus Low Resistance Strength Training ............................................................................................................................. 36 Table 10. Quality and Applicability Summary: Isokinetic Versus Isotonic Versus Isometric Strength Training .............................................................................................. 37 Table 11. Quality and Applicability Summary: Proprioception Versus Control .............. 37 Table 12. Quality and Applicability Summary: Physical Therapy Versus Control .......... 37 Table 13. Quality and Applicability Summary: Kinesthesia Plus Strengthening Versus Strengthening Only ........................................................................................................... 39 Table 14. Quality and Applicability Summary: Agility Plus Perturbation Versus Standard Exercise Therapy .............................................................................................................. 39 Table 15. Quality and Applicability Summary: Self-Management Plus Exercise Versus Exercise Alone .................................................................................................................. 40 Table 16. Quality and Applicability Summary: Aerobic Exercise Versus Education ...... 40 Table 17. Quality and Applicability Summary: Home-Based Exercise, Self-Management, and Coping Strategies Versus Usual Care ........................................................................ 41 Table 18. Quality and Applicability Summary: Water Versus Land-Based Exercises .... 44 Table 19. Quality and Applicability Summary: Supervised Walking Versus Usual Care 44 Table 20. Quality and Applicability Summary: Yoga Plus Physiotherapy Versus Physiotherapy Only ........................................................................................................... 45 Table 21. Quality and Applicability Summary: Standardized Consultation Versus Usual Care ................................................................................................................................... 45 Table 22. Quality and Applicability: Strength Training Versus Control .................. 61 Table 23. Quality and Applicability: High Versus Low Resistance Training ........... 66 Table 24. Quality and Applicability: Isokinetic Versus Isotonic Versus Isometric Strength Training............................................................................................................ 67 Table 25. Quality and Applicability: Strength Training Versus Education ............. 68 Table 26. Quality and Applicability: Proprioceptive Versus Control ...................... 69 Table 27. Quality and Applicability: Physical Therapy Versus Control ................... 70 Table 28. Quality and Applicability: Kinesthesia Plus Strengthening Versus Strengthening Alone ....................................................................................................... 74 Table 29. Quality and Applicability: Agility Plus Perturbation Versus Standard Exercise Therapy ............................................................................................................ 75 Table 30. Quality and Applicability: Self-Management Versus Control................... 78 Table 31. Quality and Applicability: Supervised Walking Versus Control .............. 84 Table 32. Quality and Applicability: Water Versus Land-Based Exercise ............... 85 Table 33. Quality and Applicability: Aerobic Exercise Versus Education................ 86 ix Table 34. Quality and Applicability: Weight Bearing and Non-Weight Bearing Exercise Programs .......................................................................................................... 88 Table 35. Quality and Applicability: Home and Class-Based Exercise Programs ... 90 Table 36. Quality and Applicability: Standardized Structured Physician Consultation Program (Education) Versus Control .................................................... 93 Table 37. Quality and Applicability: Integrated Exercise, Self-Management, and Coping Strategies Versus Usual Care ........................................................................... 94 Table 38. Quality and Applicability: Yoga Plus Physiotherapy Versus Physiotherapy Only ........................................................................................................ 96 Table 39. Strength Training Compared to Control: Pain Outcomes ......................... 98 Table 40. Isokinetic Versus Isotonic Versus Isometric Exercise: Pain ...................... 99 Table 41. Strength Training Versus Control: Functional Measure ......................... 100 Table 42. Strengthening Versus Control: WOMAC Total ....................................... 103 Table 43. High Versus Low Resistance Training: Function ..................................... 104 Table 44. Resistance Strength Training Versus Health Education ......................... 104 Table 45. Physical Therapy Versus Control: Pain Measures ................................... 105 Table 46. Physical Therapy Versus Control: Functional Measures........................ 106 Table 47. Exercise Plus Manual Physical Therapy Versus Non-Therapeutic Intensity Ultrasound ..................................................................................................... 108 Table 48. Proprioceptive Training Versus Control: Pain Measures ........................ 109 Table 49. Proprioceptive Training Versus No Exercise: Function........................... 109 Table 50. Agility and Perturbation Training Plus Usual Exercise Versus Exercise Only (Fitzgerald 2011) .................................................................................................. 109 Table 51. Agility and Perturbation Training Plus Usual Exercise Versus Exercise Only: Odds of Improvement From Baseline for WOMAC Functional Tasks (Teixeira 2011) ............................................................................................................... 110 Table 52. Kinesthesia Plus Strength Training Versus Strength Training: Function ......................................................................................................................................... 112 Table 53. Weight Bearing and Non-Weight Bearing Exercise ................................. 113 Table 54. Water Versus Land-Based Exercise: Pain ................................................. 115 Table 55. Water Versus Land-Based Exercise: Lequesne Index .............................. 116 Table 56. Home-Based and Hospital-Based Exercise Programs .............................. 117 Table 57. Aerobic Exercise Versus Control: Function .............................................. 120 Table 58. Aerobic Exercise Versus Control: Functional Task ................................. 121 Table 59. Supervised Walking Versus Usual Care: Pain .......................................... 121 Table 60. Supervised Walking Versus Usual Care: Function .................................. 122 Table 61. Supervised Walking Versus Control: Arthritis Impact Measurement Scale (Medications Use) .......................................................................................................... 122 Table 62. Self-Management Versus Waitlist Control ................................................ 123 Table 63. Self-Management Plus Exercise Versus Usual Care: Pain ....................... 129 Table 64. Self-Management Plus Exercise Versus Usual Care: Function ............... 129 Table 65. Structured Consultation Versus Control: Function ................................ 130 Table 66. Integrated Exercise, Self-Management, and Coping Strategies Versus Usual Care (Hurley 2007) ............................................................................................. 132 Table 67. Yoga Plus Physiotherapy Versus Physiotherapy Only (Ebenezer 2011) 135 Table 68. Quality and Applicability Summary: Weight Loss Versus Education ... 139 x
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