Surgical Management of Osteoarthritis of the Knee · Guideline on the Surgical Management of...

1 * See Appendix XIII for details regarding support

Surgical Management of Osteoarthritis of the Knee

Evidence-Based Clinical Practice Guideline

Adopted by: The American Academy of Orthopaedic Surgeons Board of Directors September 4, 2015

Supported* by:

Endorsed by:

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Disclaimer

This Clinical Practice Guideline was developed by an AAOS physician volunteer Guideline development group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances.

Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines.

Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this document.

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 FDA clearance status of each drug or device he or she wishes to use in clinical practice.

Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, 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. If you wish to request permission please contact the AAOS Evidence-Based Medicine Unit at [email protected].

Published 12.4.15 by the American Academy of Orthopaedic Surgeons 9400 West Higgins Rd. Rosemont, IL 60018 First Edition Copyright 12.4.15 by the American Academy of Orthopaedic Surgeons

mailto:[email protected]

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SUMMARY OF RECOMMENDATIONS

The following is a summary of the recommendations of the AAOS Clinical Practice Guideline on the Surgical Management of Osteoarthritis of the Knee. All readers of this summary are strongly urged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility.

This summary of recommendations is not intended to stand alone. Treatment decisions should be made in light of all circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician, and other healthcare practitioners.

Strength of Recommendation Descriptions

Strength

Overall Strength

of Evidence Description of Evidence Quality Strength Visual

Strong Strong

Evidence from two or more “High” quality studies with consistent findings for recommending for or against the intervention.

Moderate Moderate

Evidence from two or more “Moderate” quality studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention.

Limited

Low Strength Evidence

or Conflicting Evidence

Evidence from two or more “Low” quality studies with consistent findings or evidence from a single “Moderate” quality study recommending for against the intervention or diagnostic or the evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention.

Consensus* No Evidence

There is no supporting evidence. In the absence of reliable evidence, the guideline development group is making a recommendation based on their clinical opinion. Consensus statements are published in a separate, complimentary document.

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BMI AS A RISK FACTOR Strong evidence supports that obese patients have less improvement in outcomes with total knee arthroplasty (TKA).

Strength of Recommendation: Strong Evidence

Description: Evidence from two or more “High” strength studies with consistent findings for recommending for or against the intervention.

DIABETES AS A RISK FACTOR Moderate evidence supports that patients with diabetes are at higher risk for complications with total knee arthroplasty (TKA).

Strength of Recommendation: Moderate Evidence

Description: Evidence from two or more “Moderate” strength studies with consistent findings, or evidence from a single “High” quality study for recommending for or against the intervention.

CHRONIC PAIN AS A RISK FACTOR Moderate evidence supports that patients with select chronic pain conditions have less improvement in patient reported outcomes with TKA.



DEPRESSION/ANXIETY AS A RISK FACTOR Limited evidence supports that patients with depression and/or anxiety symptoms have less improvement in patient reported outcomes with total knee arthroplasty (TKA).

Strength of Recommendation: Limited Evidence

Description: Evidence from two or more “Low” strength studies with consistent findings or evidence from a single study for recommending for or against the intervention or diagnostic test or the evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention.

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CIRRHOSIS/HEPATITIS C AS A RISK FACTOR Limited evidence supports that patients with cirrhosis or hepatitis C are at higher risk for complications with total knee arthroplasty (TKA).



PREOPERATIVE PHYSICAL THERAPY Limited evidence supports that supervised exercise before total knee arthroplasty (TKA) might improve pain and physical function after surgery.



DELAY TKA Moderate evidence supports that an eight month delay to total knee arthroplasty (TKA) does not worsen outcomes.



PERIARTICULAR LOCAL ANESTHETIC INFILTRATION Strong evidence supports the use of peri-articular local anesthetic infiltration compared to placebo in total knee arthroplasty (TKA) to decrease pain and opioid use.



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PERIPHERAL NERVE BLOCKADE Strong evidence supports that peripheral nerve blockade for total knee arthroplasty (TKA) decreases postoperative pain and opioid requirements.



NEURAXIAL ANESTHESIA Moderate evidence supports that neuraxial anesthesia could be used in total knee arthroplasty (TKA) to improve select perioperative outcomes and complication rates compared to general anesthesia.



TOURNIQUET: BLOOD LOSS REDUCTION Moderate evidence supports that the use of a tourniquet in total knee arthroplasty (TKA) decreases intraoperative blood loss.



TOURNIQUET: POSTOPERATIVE PAIN REDUCTION Strong evidence supports that tourniquet use in total knee arthroplasty (TKA) increases short term post-operative pain.



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TOURNIQUET: POSTOPERATIVE FUNCTION Limited evidence supports that tourniquet use in total knee arthroplasty (TKA) decreases short term post-operative function.



TRANEXAMIC ACID Strong evidence supports that, in patients with no known contraindications, treatment with tranexamic acid decreases postoperative blood loss and reduces the necessity of postoperative transfusions following total knee arthroplasty (TKA).



ANTIBIOTIC BONE CEMENT Limited evidence does not support the routine use of antibiotics in the cement for primary total knee arthroplasty (TKA).



CRUCIATE RETAINING ARTHROPLASTY Strong evidence supports no difference in outcomes or complications between posterior stabilized and posterior cruciate retaining arthroplasty designs.



POLYETHYLENE TIBIAL COMPONENT Strong evidence supports use of either all-polyethylene or modular tibial components in knee arthroplasty (KA) because of no difference in outcomes.

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PATELLAR RESURFACING: PAIN AND FUNCTION Strong evidence supports no difference in pain or function with or without patellar resurfacing in total knee arthroplasty.



PATELLAR RESURFACING: REOPERATIONS Moderate evidence supports that patellar resurfacing in total knee arthroplasty (TKA) could decrease cumulative reoperations after 5 years when compared to no patellar resurfacing in total knee arthroplasty (TKA).



CEMENTED TIBIAL COMPONENTS VERSUS CEMENTLESS TIBIAL COMPONENTS Strong evidence supports the use of tibial component fixation that is cemented or cementless in total knee arthroplasty due to similar functional outcomes and rates of complications and reoperations.



CEMENTED FEMORAL & TIBIAL COMPONENTS VERSUS CEMENTLESS FEMORAL & TIBIAL COMPONENTS Moderate evidence supports the use of either cemented femoral and tibial components or cementless femoral and tibial components in knee arthroplasty due to similar rates of complications and reoperations.


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ALL CEMENTED COMPONENTS VERSUS HYBRID FIXATION (CEMENTLESS FEMORAL COMPONENT) Moderate evidence supports the use of either cementing all components or hybrid fixation (cementless femur) in total knee arthroplasty due to similar functional outcomes and rates of complications and reoperations.



ALL CEMENTLESS COMPONENTS VERSUS HYBRID FIXATION (CEMENTLESS FEMORAL COMPONENT) Limited evidence supports the use of either all cementless components or hybrid fixation (cementless femur) in total knee arthroplasty due to similar rates of complications and reoperations.



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BILATERAL TKA Limited evidence supports simultaneous bilateral total knee arthroplasty (TKA) for patients aged 70 or younger or ASA status 1-2, because there are no increased complications.



UKA: REVISIONS Moderate evidence supports that total knee arthroplasty (TKA) could be used to decrease revision surgery risk compared to unicompartmental knee arthroplasty (UKA) for medial compartment osteoarthritis.



UKA: DVT & MANIPULATION UNDER ANESTHESIA Limited evidence supports that unicompartmental knee arthroplasty might be used to decrease the risk of deep vein thrombosis (DVT) and manipulation under anesthesia compared to total knee arthroplasty (TKA) for medial compartment osteoarthritis.



UKA VERSUS OSTEOTOMY Moderate evidence supports no difference between unicompartmental knee arthroplasty (UKA) or valgus-producing proximal tibial osteotomy in outcomes and complications in patients with medial compartment knee osteoarthritis.



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SURGICAL NAVIGATION Strong evidence supports not using intraoperative navigation in total knee arthroplasty (TKA) because there is no difference in outcomes or complications.



PATIENT SPECIFIC INSTRUMENTATION: PAIN AND FUNCTION Strong evidence supports not using patient specific instrumentation compared to conventional instrumentation for total knee arthroplasty (TKA) because there is no difference in pain or functional outcomes.



PATIENT SPECIFIC INSTRUMENTATION: TRANSFUSIONS AND COMPLICATIONS Moderate evidence supports not using patient specific instrumentation compared to conventional instrumentation for total knee arthroplasty (TKA) because there is no difference in transfusions or complications.



DRAINS Strong evidence supports not using a drain with total knee arthroplasty (TKA) because there is no difference in complications or outcomes.



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CRYOTHERAPY DEVICES Moderate evidence supports that cryotherapy devices after knee arthroplasty (KA) do not improve outcomes.



CONTINUOUS PASSIVE MOTION Strong evidence supports that CPM after knee arthroplasty (KA) does not improve outcomes.



POSTOPERATIVE MOBILIZATION: LENGTH OF STAY Strong evidence supports that rehabilitation started on the day of the total knee arthroplasty (TKA) reduces length of hospital stay.



POSTOPERATIVE MOBILIZATION: PAIN AND FUNCTION Moderate evidence supports that rehabilitation started on day of total knee arthroplasty (TKA) compared to rehabilitation started on postop day 1 reduces pain and improves function.



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EARLY STAGE SUPERVISED EXERCISE PROGRAM: FUNCTION Moderate evidence supports that a supervised exercise program during the first two months after total knee arthroplasty (TKA) improves physical function.



EARLY STAGE SUPERVISED EXERCISE PROGRAM: PAIN Limited evidence supports that a supervised exercise program during the first two months after total knee arthroplasty (TKA) decreases pain.



LATE STAGE POSTOPERATIVE SUPERVISED EXERCISE PROGRAM: FUNCTION Limited evidence supports that selected patients might be referred to an intensive supervised exercise program during late stage post total knee arthroplasty (TKA) to improve physical function.



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TABLE OF CONTENTS Summary of Recommendations .......................................................................................... 4

BMI as A Risk Factor ..................................................................................................... 5 Diabetes as a Risk Factor ................................................................................................ 5 Chronic Pain as a Risk Factor ......................................................................................... 5 Depression/Anxiety as a Risk Factor .............................................................................. 5 Cirrhosis/Hepatitis C as a Risk Factor ............................................................................ 6 Preoperative Physical Therapy ....................................................................................... 6 Delay TKA ...................................................................................................................... 6 Periarticular Local Anesthetic Infiltration ...................................................................... 6 Peripheral Nerve Blockade ............................................................................................. 7 Neuraxial Anesthesia ...................................................................................................... 7 Tourniquet: Blood Loss Reduction ................................................................................. 7 Tourniquet: Postoperative Pain Reduction ..................................................................... 7 Tourniquet: Postoperative Function ................................................................................ 8 Tranexamic Acid ............................................................................................................. 8 Antibiotic Bone Cement ................................................................................................. 8 Cruciate Retaining Arthroplasty ..................................................................................... 8 Polyethylene Tibial Component ..................................................................................... 8 Patellar Resurfacing: Pain and Function ......................................................................... 9 Patellar Resurfacing: Reoperations ................................................................................. 9 Cemented Tibial Components Versus Cementless Tibial Components ......................... 9 Cemented Femoral & Tibial Components Versus Cementless Femoral & Tibial Components .................................................................................................................... 9 All Cemented Components versus Hybrid Fixation (Cementless Femoral Component)....................................................................................................................................... 10 All Cementless Components versus Hybrid Fixation (Cementless Femoral Component)....................................................................................................................................... 10 Bilateral TKA................................................................................................................ 11 UKA: Revisions ........................................................................................................... 11 UKA: DVT & Manipulation Under Anesthesia ........................................................... 11 UKA Versus Osteotomy ............................................................................................... 11 Surgical Navigation ...................................................................................................... 12 Patient Specific Instrumentation: Pain and Function .................................................... 12 Patient Specific Instrumentation: Transfusions and Complications ............................. 12 Drains ............................................................................................................................ 12 Cryotherapy Devices ..................................................................................................... 13 Continuous Passive Motion .......................................................................................... 13 Postoperative Mobilization: Length of Stay ................................................................. 13 Postoperative Mobilization: Pain and Function ............................................................ 13 Early Stage Supervised Exercise Program: Function ................................................... 14 Early Stage Supervised Exercise Program: Pain .......................................................... 14 Late Stage Postoperative Supervised Exercise Program: Function .............................. 14 Table of Contents .......................................................................................................... 15 List of Tables ................................................................................................................ 21 Table of Figures ............................................................................................................ 26

Introduction ....................................................................................................................... 27 Overview ....................................................................................................................... 27

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Goals and Rationale ...................................................................................................... 27 Intended Users .............................................................................................................. 27 Patient Population ......................................................................................................... 28 Burden of Disease ......................................................................................................... 28 Etiology ......................................................................................................................... 28 Incidence and Prevalence .............................................................................................. 28 Risk Factors .................................................................................................................. 29 Emotional and Physical Impact .................................................................................... 29 Potential Benefits, Harms, and Contraindications ........................................................ 29 Future Research ............................................................................................................ 30

Methods............................................................................................................................. 30 Formulating PICO Questions ........................................................................................ 31 Study Selection Criteria ................................................................................................ 31 Best Evidence Synthesis ............................................................................................... 32 Minimally Clinically Important Improvement.............................................................. 32 Literature Searches........................................................................................................ 33 Methods for Evaluating Evidence ................................................................................. 33 Defining the Strength of the Recommendations ........................................................... 35 Wording of the Final Recommendations ...................................................................... 36 Applying the Recommendations to Clinical Practice ................................................... 36 Voting on the Recommendations .................................................................................. 37 Statistical Methods ........................................................................................................ 37 Peer Review .................................................................................................................. 38 Public Commentary ...................................................................................................... 39 The AAOS Guideline Approval Process ...................................................................... 39 Revision Plans ............................................................................................................... 39 Guideline Dissemination Plans ..................................................................................... 39

Recommendations ............................................................................................................. 41 Overview of Articles by Recommendation ................................................................... 41 Risk Stratification Recommendations........................................................................... 42 BMI as A Risk Factor ................................................................................................... 42 Diabetes as a Risk Factor .............................................................................................. 42 Chronic Pain as a Risk Factor ....................................................................................... 42 Depression/Anxiety as a Risk Factor ............................................................................ 42 Cirrhosis/Hepatitis C as a Risk Factor .......................................................................... 42

Rationales .................................................................................................................. 43 Rationale: BMI as a Risk Factor ............................................................................... 43 Rationale: Diabetes as a Risk Factor ........................................................................ 43 Rationale: Chronic Pain as a Risk Factor ................................................................. 43 Rationale: Depression/Anxiety as a Risk Factor ...................................................... 43 Rationale: Cirrhosis/Hepatitis C as a Risk Factor..................................................... 43 Risk/harms statement ................................................................................................ 43 Future Research ........................................................................................................ 44 Results ....................................................................................................................... 45

Preoperative Physical Therapy ..................................................................................... 81 Rationale ................................................................................................................... 81 Possible Harms of Implementation ........................................................................... 82 Future Research ........................................................................................................ 82

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Results ....................................................................................................................... 83 Summary of Findings Table 22: Pre-Operative Structured Exercise........................ 83 Quality Evaluation Table 12: Pre-Operative Structured Exercise Program ............ 84 Detailed Data Tables ................................................................................................. 85

Delayed Total Knee Arthroplasty ............................................................................... 112 Rationale ................................................................................................................. 112 Risks and Harms of Implementing this Recommendation ..................................... 112 Future Research ...................................................................................................... 112 Results ..................................................................................................................... 113

Peripheral Nerve Blockade (PNB) .............................................................................. 118 Rationale ................................................................................................................. 118 Risks and Harms of Implementing this Recommendation ..................................... 118 Future Research ...................................................................................................... 118 Results ..................................................................................................................... 119

Peri-Articular Local Anesthetic Infiltration ................................................................ 164 Rationale ................................................................................................................. 164 Risks and Harms of Implementing this Recommendation ..................................... 164 Future Research ...................................................................................................... 164 Results ..................................................................................................................... 165

Neuraxial Anesthesia .................................................................................................. 179 Rationale ................................................................................................................. 179 Risks and Harms of Implementing this Recommendation ..................................... 179 Future Research ...................................................................................................... 179 Results ..................................................................................................................... 181

Tourniquets ................................................................................................................. 200 A. Tourniquet: Blood Loss Reduction ..................................................................... 200 B. Tourniquet: Postoperative Pain Reduction ......................................................... 200 C. Tourniquet: Postoperative Function .................................................................... 200

Rationale ................................................................................................................. 200 Risks and Harms of Implementing this Recommendation ..................................... 201 Future Research ...................................................................................................... 201 Results ..................................................................................................................... 202

Tranexamic Acid ......................................................................................................... 211 Rationale ................................................................................................................. 211 Risks and Harms of Implementing this Recommendation ..................................... 211 Future Research ...................................................................................................... 211 Results ..................................................................................................................... 212

Antibiotic Bone Cement ............................................................................................. 231 Rationale ................................................................................................................. 231 Risks and Harms of Implementing this Recommendation ..................................... 231 Future Research ...................................................................................................... 231 Results ..................................................................................................................... 232

Cruciate Retaining Arthroplasty ................................................................................. 238 Rationale ................................................................................................................. 238 Risks and Harms of Implementing this Recommendation ..................................... 238 Future Research ...................................................................................................... 238 Results ..................................................................................................................... 239

Polyethylene Tibial Components ................................................................................ 253

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Rationale ................................................................................................................. 253 Risks and Harms of Implementing this Recommendation ..................................... 254 Future Research ...................................................................................................... 254 Results ..................................................................................................................... 255 Summary of Findings Table 34: All Polyethylene Tibial Components .................. 255

Patellar Resurfacing .................................................................................................... 276 A. Patellar Resurfacing: Pain and Function ............................................................. 276 B. Patellar Resurfacing: Reoperations ..................................................................... 276


Bone Cement ............................................................................................................... 304 Cemented Tibial Components Versus Cementless Tibial Components ..................... 304 Cemented Femoral & Tibial Components Versus Cementless Femoral & Tibial Components ................................................................................................................ 304 All Cemented Components versus Hybrid Fixation (Cementless Femoral Component)..................................................................................................................................... 304 All Cementless Components versus Hybrid Fixation (Cementless Femoral Component)..................................................................................................................................... 304

Rationale ................................................................................................................. 305 Risks and Harms of Implementing this Recommendation ..................................... 305 Future Research ...................................................................................................... 306 Results ..................................................................................................................... 307 Summary of Findings Table 11: Part 1 Tibial Component Cementing .................. 308

Bilateral TKA.............................................................................................................. 348 Rationale ................................................................................................................. 348 Risks and Harms of Implementing this Recommendation ..................................... 348 Future Research ...................................................................................................... 348 Results ..................................................................................................................... 349

Unicompartmental Knee Arthroplasty (UKA)............................................................ 354 A. UKA: Revisions .................................................................................................. 354 B. UKA: DVT & Manipulation Under Anesthesia ................................................. 354 C. UKA Versus Osteotomy ..................................................................................... 354


Surgical Navigation .................................................................................................... 379 Rationale ................................................................................................................. 379 Risks and Harms of Implementing this Recommendation ..................................... 379 Future Research ...................................................................................................... 379 Results ..................................................................................................................... 380

Patient Specific Technology ....................................................................................... 397 A. Patient Specific Instrumentation: Pain and Function .......................................... 397 B. Patient Specific Instrumentation: Transfusions and Complications ................... 397

Rationale ................................................................................................................. 397 Risks and Harms of Implementing this Recommendation ..................................... 397

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Future Research ...................................................................................................... 398 Results ..................................................................................................................... 399

Drains .......................................................................................................................... 409 Rationale ................................................................................................................. 409 Risks and Harms of Implementing this Recommendation ..................................... 409 Future Research ...................................................................................................... 409 Results ..................................................................................................................... 410 Summary of Findings Table 1: Drains Versus No Drains ...................................... 410 Quality Evaluation Table 1: Drains ....................................................................... 413

Cryotherapy Devices ................................................................................................... 422 Risks and Harms of Implementing this Recommendation ..................................... 422 Future Research ...................................................................................................... 423 Results ..................................................................................................................... 423

Continuous Passive Motion (CPM) ............................................................................ 433 Rationale ................................................................................................................. 433 Risks and Harms of Implementing this Recommendation ..................................... 433 Future Research ...................................................................................................... 433 Results ..................................................................................................................... 434

Postoperative Mobilization ......................................................................................... 455 A. Postoperative Mobilization: Length of Stay ....................................................... 455 B. Postoperative Mobilization: Pain and Function .................................................. 455


Structured Exercise Program ...................................................................................... 465 A. Early Stage Supervised Exercise Program: Function ......................................... 465 B. Early Stage Supervised Exercise Program: Pain ................................................ 465 C. Late Stage Postoperative Supervised Exercise Program: Function .................... 465


I. Appendixes ............................................................................................................. 501 Appendix I. Guideline development group Roster ..................................................... 501

Guidelines Oversight Chair ..................................................................................... 502 AAOS Clinical Practice Guidelines Section Leader ............................................... 502 AAOS Council on Research and Quality Chair ...................................................... 502 Additional Contributing Members .......................................................................... 503 AAOS Staff ............................................................................................................. 503

Appendix II ................................................................................................................. 504 AAOS Bodies That Approved This Clinical Practice Guideline ............................ 504

Appendix III ................................................................................................................ 505 PICO Questions Used to Define Literature Search ................................................. 505

Appendix IV................................................................................................................ 509 Study Attrition Flowchart ....................................................................................... 509

Appendix V ................................................................................................................. 510 Literature Search Strategies .................................................................................... 510

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Appendix VI................................................................................................................ 513 Opinion Based Recommendations .......................................................................... 513 Companion Consensus Statements ......................................................................... 514

Appendix VII .............................................................................................................. 515 Participating Peer Review Organizations ............................................................... 515 Structured Peer Review Form ................................................................................. 516

Appendix VIII ............................................................................................................. 518 Interpreting the Forest Plots .................................................................................... 518

Appendix IX................................................................................................................ 519 Conflict of Interest .................................................................................................. 519

Appendix X ................................................................................................................. 522 Bibliographies ......................................................................................................... 522 Introduction and Methods ....................................................................................... 522 Included Studies ...................................................................................................... 522 Lower Quality Studies that met the Inclusion Criteria but Were Excluded for Not Best Available Evidence ......................................................................................... 543 Excluded Studies ..................................................................................................... 547

Appendix XIII ............................................................................................................. 663 Letters of Endorsement from External Organizations ............................................ 663

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LIST OF TABLES Table 1. Strength of Recommendation Descriptions ........................................................ 36 Table 2. AAOS Guideline Language Stems ..................................................................... 36 Table 3. Clinical Applicability: Interpreting the Strength of a Recommendation ............ 37 Table 4: - Risk Stratification: Chronic Pain ...................................................................... 49 Table 5: Risk Stratification: Diabetes .............................................................................. 50 Table 6: Risk Stratification: Liver Disease ...................................................................... 52 Table 7: Risk Stratification: Neurologic Disease............................................................. 56 Table 8: Risk Stratification: Obesity................................................................................ 57 Table 9: Risk Stratification: Renal Insufficiency............................................................. 79 Table 10: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Composite ........................................................................................... 85 Table 11: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Function............................................................................................... 87 Table 12: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Length of Stay ................................................................................... 102 Table 13: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Pain .................................................................................................... 103 Table 14: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Quality of Life ................................................................................... 109 Table 15: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Stiffness ............................................................................................. 110 Table 16: Pre-Operative structure exercise program Versus No Pre-Operative structure exercise program: Other .................................................................................................. 111 Table 17: - Delayed Total Knee Arthroplasty Versus Early Total Knee Arthroplasty: Composite ....................................................................................................................... 115 Table 18: Delayed Total Knee Arthroplasty Versus Early Total Knee Arthroplasty: Function .......................................................................................................................... 116 Table 19: Delayed Total Knee Arthroplasty Versus Early Total Knee Arthroplasty: Pain......................................................................................................................................... 117 Table 20: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Complications ............................................................................................ 123 Table 21: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Composite .................................................................................................. 131 Table 22: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Function ..................................................................................................... 132 Table 23: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Length of Stay ............................................................................................ 140 Table 24: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Other Outcomes ......................................................................................... 141 Table 25: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Pain............................................................................................................. 151 Table 26: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Post-op Pain Control .................................................................................. 159 Table 27: Peri-Operative peripheral nerve block versus No Peri-Operative peripheral nerve block: Stiffness ...................................................................................................... 163 Table 28: Part 1- Peri-Articular Local Infiltration versus Saline: Complications .......... 166 Table 29: Part 1- Peri-Articular Local Infiltration versus Saline: Function ................... 169

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Table 30: Part 1- Peri-Articular Local Infiltration versus Saline: Pain .......................... 171 Table 31: Part 1- Peri-Articular Local Infiltration versus Saline: Post-op Pain Control 174 Table 32: Part 1- Peri-Articular Local Infiltration versus Saline: Other Outcomes ....... 175 Table 33: Neuraxial Anesthesia Versus General Anesthesia: Complications .............. 183 Table 34: Neuraxial Anesthesia Versus General Anesthesia: Function ....................... 195 Table 35: Neuraxial Anesthesia Versus General Anesthesia: Length of Stay .............. 197 Table 36: Neuraxial Anesthesia Versus General Anesthesia: Length of Surgery ........ 198 Table 37: Neuraxial Anesthesia Versus General Anesthesia: Mortality ...................... 199 Table 38: Tourniquet Versus No Tourniquet: Blood Loss and Need for Transfusion .. 203 Table 39: Tourniquet Versus No Tourniquet: Other Complications ............................. 205 Table 40: Tourniquet Versus No Tourniquet: Function ................................................ 205 Table 41: Tourniquet Versus No Tourniquet: Pain ........................................................ 207 Table 42: Tourniquet Versus No Tourniquet: Quality of Life ....................................... 208 Table 43: Tourniquet Versus No Tourniquet: Reoperation ........................................... 209 Table 44: Tourniquet Versus No Tourniquet: Other Outcomes .................................... 210 Table 45: Tranexamic Acid Versus Placebo: Complications ........................................ 216 Table 46: Tranexamic Acid Versus Placebo: Composite .............................................. 228 Table 47: Tranexamic Acid Versus Placebo: Function ................................................. 229 Table 48: Tranexamic Acid Versus Placebo: Reoperation ............................................ 230 Table 49: - Antibiotic Cement Versus No Antibiotic Cement: Complications .............. 233 Table 50: Antibiotic Cement Versus No Antibiotic Cement: Function ........................ 235 Table 51: Antibiotic Cement Versus No Antibiotic Cement: Length of Stay .............. 236 Table 52: Antibiotic Cement Versus No Antibiotic Cement: Reoperation .................. 237 Table 53: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Complications ................................................................................................................. 243 Table 54: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Composite ....................................................................................................................... 244 Table 55: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Function .......................................................................................................................... 245 Table 56: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Pain......................................................................................................................................... 249 Table 57: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Quality of Life................................................................................................................. 250 Table 58: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Reoperation ..................................................................................................................... 251 Table 59: Cruciate Retaining Arthroplasty Versus Posterior Stabilize Arthroplasty: Other Outcomes ........................................................................................................................ 252 Table 60: All Polyethylene Tibial Components Versus Metal Tibial Components: Complications ................................................................................................................. 256 Table 61: All Polyethylene Tibial Components Versus Metal Tibial Components: Composite ....................................................................................................................... 264 Table 62: All Polyethylene Tibial Components Versus Metal Tibial Components: Function .......................................................................................................................... 266 Table 63: All Polyethylene Tibial Components Versus Metal Tibial Components: Mortality ......................................................................................................................... 267 Table 64: All Polyethylene Tibial Components Versus Metal Tibial Components: Pain......................................................................................................................................... 268

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Table 65: All Polyethylene Tibial Components Versus Metal Tibial Components: Quality of Life................................................................................................................. 269 Table 66: All Polyethylene Tibial Components Versus Metal Tibial Components: Reoperation ..................................................................................................................... 272 Table 67: Patellar Resurfacing Versus No Patellar Resurfacing: Complications .......... 282 Table 68: Patellar Resurfacing Versus No Patellar Resurfacing: Composite ................ 283 Table 69: Patellar Resurfacing Versus No Patellar Resurfacing: Function ................... 284 Table 70: Patellar Resurfacing Versus No Patellar Resurfacing: Length of Stay ......... 291 Table 71: Patellar Resurfacing Versus No Patellar Resurfacing: Pain .......................... 292 Table 72: Patellar Resurfacing Versus No Patellar Resurfacing: Quality of Life ......... 295 Table 73: Patellar Resurfacing Versus No Patellar Resurfacing: Reoperation .............. 299 Table 74: Patellar Resurfacing Versus No Patellar Resurfacing: Other Outcomes ....... 303 Table 75 Part 1 Tibial Components Cemented Versus Tibial Components Uncemented......................................................................................................................................... 313 Table 76 Part 2 Femoral And Tibial Components Cemented Versus Femoral And Tibial Components Uncemented ............................................................................................... 333 Table 77 Part 3 All Replaced Components Versus All But Femoral Components Replaced (Hybrid) ........................................................................................................... 340 Table 78 Part 4 All But Femoral Components Cemented (Hybrid) Versus All Components Uncemented ............................................................................................... 347 Table 79: Simultaneous Bi-Lateral Knee Arthroplasty Versus Staged Knee Arthroplasty: Complications ................................................................................................................. 350 Table 80: Simultaneous Bi-Lateral Knee Arthroplasty Versus Staged Knee Arthroplasty: Mortality ......................................................................................................................... 353 Table 81: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Complications ................................................................................................................. 362 Table 82: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Composite ....................................................................................................................... 363 Table 83: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Length of Stay ................................................................................................................. 365 Table 84: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Mortality ......................................................................................................................... 366 Table 85: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Pain ................................................................................................................................. 367 Table 86: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Quality of Life................................................................................................................. 368 Table 87: Part 1- Unicompartmental Knee Arthroplasty Versus Total Knee Replacement: Reoperation ..................................................................................................................... 371 Table 88: Part 2- Unicompartmental Knee Arthroplasty Versus Osteotomy: Complications ................................................................................................................. 372 Table 89: Part 2- Unicompartmental Knee Arthroplasty Versus Osteotomy: Function . 374 Table 90: Part 2- Unicompartmental Knee Arthroplasty Versus Osteotomy: Pain ........ 377 Table 91: Part 2- Unicompartmental Knee Arthroplasty Versus Osteotomy: Reoperation......................................................................................................................................... 378 Table 92: Surgical Navigation Versus No Surgical Navigation: Complications ........... 386 Table 93: Surgical Navigation Versus No Surgical Navigation: Composite ................. 390 Table 94: Surgical Navigation Versus No Surgical Navigation: Function .................... 390 Table 95: Surgical Navigation Versus No Surgical Navigation: Length of Surgery ..... 393

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Table 96: Surgical Navigation Versus No Surgical Navigation: Pain ........................... 394 Table 97: Surgical Navigation Versus No Surgical Navigation: Reoperation .............. 395 Table 98: Surgical Navigation Versus No Surgical Navigation: Stiffness .................... 396 Table 99: Patient Specific Technology Versus Conventional Instrumentation: Complications ................................................................................................................. 401 Table 100: Patient Specific Technology Versus Conventional Instrumentation: Composite ....................................................................................................................... 403 Table 101: Patient Specific Technology Versus Conventional Instrumentation: Function......................................................................................................................................... 404 Table 102: Patient Specific Technology Versus Conventional Instrumentation: Length of Stay ................................................................................................................................. 405 Table 103: Patient Specific Technology Versus Conventional Instrumentation: Length of Surgery ............................................................................................................................ 406 Table 104: Patient Specific Technology Versus Conventional Instrumentation: Pain .. 407 Table 105: Part 1- Drains Versus No Drains: Complications ......................................... 414 Table 106: Part 1- Drains Versus No Drains: Function ................................................. 418 Table 107: Part 1- Drains Versus No Drains: Length of Stay ....................................... 420 Table 108: Part 1- Drains Versus No Drains: Pain ........................................................ 420 Table 109: Cryotherapy versus No Cryotherapy: Complications .................................. 425 Table 110: Cryotherapy versus No Cryotherapy: Function ........................................... 427 Table 111: Cryotherapy versus No Cryotherapy: Other Outcomes ............................... 429 Table 112: Cryotherapy versus No Cryotherapy: Pain .................................................. 430 Table 113: Cryotherapy versus No Cryotherapy: Post-op Pain Control ........................ 431 Table 114: Continuous Passive Motion versus No Continuous Passive Motion: Complications ................................................................................................................. 436 Table 115: Continuous Passive Motion versus No Continuous Passive Motion: Composite ....................................................................................................................... 438 Table 116: Continuous Passive Motion versus No Continuous Passive Motion: Function......................................................................................................................................... 440 Table 117: Continuous Passive Motion versus No Continuous Passive Motion: Length of Stay ................................................................................................................................. 447 Table 118: Continuous Passive Motion versus No Continuous Passive Motion: Other Outcomes ........................................................................................................................ 449 Table 119: Continuous Passive Motion versus No Continuous Passive Motion: Pain . 451 Table 120: Continuous Passive Motion versus No Continuous Passive Motion: Stiffness......................................................................................................................................... 454 Table 121: Accelerated Mobilization versus Non-Accelerated Mobilization: Complications ................................................................................................................. 458 Table 122: Accelerated Mobilization versus Non-Accelerated Mobilization: Function 459 Table 123: Accelerated Mobilization versus Non-Accelerated Mobilization: Length of Stay ................................................................................................................................. 462 Table 124: Accelerated Mobilization versus Non-Accelerated Mobilization: Pain ...... 463 Table 125: Accelerated Mobilization versus Non-Accelerated Mobilization: Quality of Life .................................................................................................................................. 464 Table 126: Part 1- Structured Exercise versus No/Less Structured Exercise During Early Stage Post Surgery: Function .......................................................................................... 471 Table 127: Part 1- Structured Exercise versus No/Less Structured Exercise During Early Stage Post Surgery: Pain ................................................................................................. 477

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Table 128: Part 1- Structured Exercise versus No/Less Structured Exercise During Early Stage Post Surgery: Stiffness .......................................................................................... 478 Table 129: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Composite ........................................................... 478 Table 130: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Function .............................................................. 481 Table 131: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Other Outcomes .................................................. 494 Table 132: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Pain ..................................................................... 495 Table 133: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Quality of Life .................................................... 498 Table 134: Part 2- Structured Exercise versus No/Less Structured Exercise During Late Stage Post Surgery (After 2 months): Stiffness .............................................................. 499

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TABLE OF FIGURES Figure 1 Tranexamic Acid Versus Placebo – Blood Transfusion % .......................................... 214 Figure 2 No Cruciate Retaining Arthroplasty Versus Cruciate Retaining Arthroplasty-Function at 2 Years .................................................................................................................................... 241 Figure 3 Patellar Resurfacing - Reoperation Stratified by Follow up ........................................ 279 Figure 4 Patellar Resurfacing (Sensitivity Analysis) - Reoperation with Barrack 1997 and 2001 removed since reoperations for reasons other than anterior knee pain were excluded from that analysis. ....................................................................................................................................... 280 Figure 5 UKA Versus TKA: Reoperation Risk Ratio favors TKA group ................................. 360 Figure 6 Surgical Navigation Versus No Surgical Navigation – Infection ................................ 383 Figure 7 Drains Versus No Drains: Infection Peto Odds Ratio .................................................. 411 Figure 8 Drains Versus No Drains Range of Motion in Flexion ................................................ 412

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INTRODUCTION OVERVIEW This clinical practice guideline is based on a systematic review of peer-reviewed articles published from 1966 to January 27th, 2015 with regard to the surgical management of osteoarthritis of the knee in patients over the age of 18 years. The guideline development group opted to include more contemporary literature to make our conclusions as relevant as possible to the current practice of orthopaedic surgeons. In addition to providing practice recommendations, this guideline also highlights limitations in the literature and areas that require future research. This guideline is intended to be used by all qualified and appropriately trained physicians and surgeons involved in the management of surgical management of osteoarthritis of the knee. It is also intended to serve as an information resource for decision makers and developers of practice guidelines and recommendations. GOALS AND RATIONALE The purpose of this clinical practice guideline is to help improve treatment based on the current best evidence. Current evidence-based medicine (EBM) standards demand that physicians use the best available evidence in their clinical decision making. To assist them, this clinical practice guideline consists of a systematic review of the available literature regarding the management of surgical management of knee osteoarthritis in adults. The systematic review detailed herein was conducted between April 2013 and September 2015 and demonstrates where there is good evidence, where evidence is lacking, and what topics future research must target in order to improve the management of adult patients (defined as age 18 years or older) with osteoarthritis of the knee. AAOS staff and the physician work group systematically reviewed the available literature and subsequently wrote the following recommendations based on a rigorous, standardized process. Musculoskeletal care is provided in many different settings by many different providers. We created this guideline as an educational tool to guide qualified physicians through a series of treatment decisions in an effort to improve the quality and efficiency of care. This guideline should not be construed as including all proper methods of care or excluding methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding any specific procedure or treatment must be made in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. INTENDED USERS This guideline is intended to be used by orthopaedic surgeons and physicians managing adult patients with osteoarthritis of the knee. Typically, orthopaedic surgeons will have completed medical training, a qualified residency in orthopaedic surgery, and some may have completed additional sub-specialty training. Anesthesiologists, rheumatologists, physiatrists, adult primary care physicians, geriatricians, hospital based adult medicine specialists, physical therapists, occupational therapists, nurse practitioners, physician assistants, emergency physicians, and other healthcare professionals who routinely see this type of patient in various practice settings may also benefit from this guideline. This guideline is not intended for use as a benefits determination document. Making these determinations involves many factors not considered in

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the present document, including available resources, business and ethical considerations, and need. Knee osteoarthritis management is based on the assumption that decisions are predicated on the patient and/or the patient’s qualified heath care advocate having communication with the physician about available treatments and procedures applicable to the individual patient. Once the patient and or their advocate have been informed of available therapies and have discussed these options with his/her physician, an informed decision can be made. Clinician input based on experience with conservative management and the clinician’s surgical experience and skills increases the probability of identifying patients who will benefit from specific treatment options. PATIENT POPULATION This document addresses the management osteoarthritis of the knee in adult patients defined as those 18 years of age and older. It is not intended to address management of pediatric patients with osteoarthritis or patients with inflammatory arthritis of the knee. BURDEN OF DISEASE The burden of osteoarthritis (OA) of the knee is largely attributable to the effects of disability, comorbid disease, and the expense of treatment. OA is the most frequent cause of disability among adults in the United States (US), and the burden is increasing both as the prevalence of OA increases and also as patient expectations for treatment rise. Twenty seven million adults (more than 10 percent) of the US adult population had clinical osteoarthritis (OA) in 2005, and in 2009 OA was the fourth most common cause of hospitalization (Murphy & Helmick, 2012). OA is the leading indication for joint replacement surgery; 905,000 knee and hip replacements were performed in 2009 at a cost of 42.3 billion dollars (Murphy & Helmick, 2012). Costs to be considered include: 1. Direct Medical Cost 2. Long-term Medical Cost 3. Home Modification Costs 4. Nursing Home Costs ETIOLOGY Patients who require surgical treatment for osteoarthritis of the knee have developed the condition naturally over time due to a variety of risk factors or in an accelerated fashion due to prior trauma about the knee. Osteoarthritis is the imbalance of breakdown and repair of tissues within a synovial joint. The etiology of osteoarthritis is varied and includes genetic factors, trauma, prior meniscectomy, overuse, and infection.

INCIDENCE AND PREVALENCE Twenty seven million adults (more than 10 percent) of the US adult population had clinical osteoarthritis (OA) in 2005, and in 2009 OA was the fourth most common cause of hospitalization (Murphy & Helmick, 2012). The incidence of knee osteoarthritis is estimated to affect 240 persons per 100,000/year. It is estimated that 9.9 million adults had symptomatic osteoarthritis of the knee in 2010.

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With rising life expectancy, it is estimated that the prevalence of knee osteoarthritis will continue to increase. The number of people older than age 65 years is expected to increase from 37.1 million to 77.2 million by the year 2040.

RISK FACTORS Factors that increase the risk for developing osteoarthritis of the knee such that surgical treatment is required include joint degeneration over time due to hereditary vulnerability, large body mass, certain occupations, past trauma affecting the joint or subchondral bone adjacent to the joint, or prior intraarticular damage (meniscal tear or removal, anterior cruciate ligament tear). For information regarding the evidence base behind various risk factors, please refer to the recommendations within this document regarding risk stratification.

EMOTIONAL AND PHYSICAL IMPACT Older adults with self-reported osteoarthritis of the knee visit their physicians more frequently and experience greater functional limitations than others in the same age group. Patients who have moderate to severe osteoarthritis of the knee requiring surgery experience:

1. Inability to return to prior living circumstances

2. Need for increased level of care and supervision

3. Decreased quality of life

4. Decreased level of mobility and ambulation

POTENTIAL BENEFITS, HARMS, AND CONTRAINDICATIONS The benefits of surgical treatment of osteoarthritis of the knee include relief of pain and improved function. Most invasive operative treatments, primarily arthroplasty, are associated with known risks.

Early postoperative complications include prosthetic infection, venous thromboembolic disease, arthrofibrosis, and pain. Late postoperative complications include infection, prosthetic aseptic loosening, and pain. All can lead to a need for revision arthroplasty.

Contraindications are relative and require an in depth discussion with the patient and physician (surgeon, anesthesiologist) about their individual risk factors. Additional factors, such as the individual’s co-morbidities, and/or specific patient characteristics may affect the physician’s choice of treatment. Clinician input based on experience increases the probability of identifying patients who will benefit from specific treatment options. The individual patient and/or their decision surrogate dynamic will also influence treatment decisions, therefore, discussion of available treatments and procedures applicable to the individual patient rely on mutual communication between the patient and/or decision surrogate and physician, weighing the potential risks and benefits for that patient. Once the patient and/or their decision surrogate have been informed of available therapies and have discussed these options with the patient’s physician, an informed decision can be made.

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FUTURE RESEARCH Consideration for future research is provided for each recommendation within this document.

METHODS The methods used to perform this systematic review were employed to minimize bias and enhance transparency in the selection, appraisal, and analysis of the available evidence. These processes are vital to the development of reliable, transparent, and accurate clinical recommendations for treating osteoarthritis of the knee.

This clinical practice guideline and the systematic review upon which it is based evaluate the effectiveness of surgical treatments for osteoarthritis of the knee. This section describes the methods used to prepare this guideline and systematic review, including search strategies used to identify literature, criteria for selecting eligible articles, determining the strength of the evidence, data extraction, methods of statistical analysis, and the review and approval of the guideline. The AAOS approach incorporates practicing physicians (clinical experts) and methodologists who are free of potential conflicts of interest as recommended by guideline development experts.

The AAOS understands that only high-quality guidelines are credible, and we go to great lengths to ensure the integrity of our evidence analyses. The AAOS addresses bias beginning with the selection of guideline development group members. Applicants with financial conflicts of interest (COI) related to the guideline topic cannot participate if the conflict occurred within one year of the start date of the guideline’s development or if an immediate family member has, or has had, a relevant financial conflict. Additionally, all guideline development group members sign an attestation form agreeing to remain free of relevant financial conflicts for one year following the publication of the guideline.

This guideline and systematic review were prepared by the AAOS Surgical Management of Osteoarthritis of the Knee guideline physician guideline development group (clinical experts) with the assistance of the AAOS Evidence-Based Medicine (EBM) Unit in the Department of Research and Scientific Affairs (methodologists) at the AAOS. To develop this guideline, the guideline development group held an introductory meeting on August 16, 2013 to establish the scope of the guideline and the systematic reviews. As the physician experts, the guideline development group defined the scope of the guideline by creating PICO Questions (i.e. population, intervention, comparison, and outcome) that directed the literature search. The original PICO questions developed at the introductory meeting can be viewed in Appendix III. When necessary, these clinical experts also provided content help, search terms and additional clarification for the AAOS Medical Librarian. The Medical Librarian created and executed the search(es). The supporting group of methodologists (AAOS EBM Unit) reviewed all abstracts, recalled pertinent full-text articles for review and evaluated the quality of studies meeting the inclusion criteria. They also abstracted, analyzed, interpreted, and/or summarized the relevant data for each recommendation and prepared the initial draft for the final meeting. Upon completion of the systematic reviews, the physician guideline development group participated in a three-day recommendation meeting on April 10-12, 2015. At this meeting, the physician experts and methodologists evaluated and integrated all material to develop the final recommendations. The final recommendations and rationales were edited, written and voted on at the final meeting. Additional edits to the rationales were approved by the guideline

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development group on webinars after the meeting. The draft guideline recommendations and rationales received final review by the methodologists to ensure that these recommendations and rationales were consis

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