TREATMENT OF PEDIATRIC DIAPHYSEAL FEMUR FRACTURES EVIDENCE-BASED CLINICAL PRACTICE GUIDELINE Adopted by the American Academy of Orthopaedic Surgeons Board of Directors June 12, 2015 2015 REPORT FOR THE REISSUE OF THE 2009 CLINICAL PRACTICE GUIDELINE ON THE TREATMENT OF PEDIATRIC DIAPHYSEAL FEMUR FRACTURES “This guideline is greater than 5 years old and is reviewed every five years. New studies have been published since this guideline was developed, however the AAOS has determined that these studies are not sufficient to warrant changing the guideline at this time. The information contained in this guideline provides the user with the best evidence available at the time this guideline was published.” OVERVIEW OF 2015 UPDATES TO THE 2009 ORIGINAL GUIDELINE 1) Addition of the Shemshaki, et al, 2011 study findings to Elastic Intramedullary Nails. 2) Updated strength of recommendation language to match current AAOS guideline language (see Grading the Recommendations). 3) Removed “inconclusive” recommendations due to lack of evidence (see Appendix XI) For a user-friendly version of this clinical practice guideline, please visit the AAOS OrthoGuidelines Web-Based App at: http://www.orthoguidelines.org AAOS v 1.0 061909 Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work 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. Originally Published in 2009 by the American Academy of Orthopaedic Surgeons Reissued in 2015 9400 West Higgins Road Rosemont, IL 60018 Copyright 2015 by the American Academy of Orthopaedic Surgeons ii I. SUMMARY OF RECOMMENDATIONS The original guideline on the Treatment of Pediatric Diaphyseal Femur Fractures (PDFF) was the third guideline developed by the AAOS in-house. It had fourteen recommendations of varying strengths. However, per current AAOS policy, all recommendations in the original guideline identified as “inconclusive” were removed from this 2015 reissue (see Appendix XI for a full list of the inconclusive recommendations that were removed). Based on the current procedure for updating AAOS guidelines, the Medical Librarian ran a preliminary search to identify literature that could address and possibly change the original recommendations. The AAOS Evidence-Based Medicine Unit then used the inclusion criteria from the original guideline to determine if any articles published after the final literature search date of the original guideline were relevant to the original recommendations. The following is a summary of the recommendations in the AAOS’ clinical practice guideline on the Treatment of Pediatric Diaphyseal Femur Fractures (PDFF). This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. 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 also 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. iii Strength of Recommendation Descriptions Overall Strength of Strength Evidence Description of Evidence Strength Strength Visual Evidence from two or more “High” strength studies with consistent findings Strong Strong for recommending for or against the intervention. Evidence from two or more “Moderate” strength studies with consistent findings, Moderate Moderate or evidence from a single “High” quality study for recommending for or against the intervention. Evidence from two or more “Low” strength studies with consistent findings Low Strength or evidence from a single study for Evidence or recommending for or against the Limited Conflicting intervention or diagnostic test or the Evidence evidence is insufficient or conflicting and does not allow a recommendation for or against the intervention. There is no supporting evidence. In the absence of reliable evidence, the work group is making a recommendation based on their clinical opinion. Consensus* No Evidence Consensus recommendations can only be created when not establishing a recommendation could have catastrophic consequences. iv CHILD ABUSE Strong evidence supports that children younger than thirty-six months with a diaphyseal femur fracture be evaluated for child abuse. Grade of Recommendation: Strong INFANT FEMUR FRACTURE Limited evidence supports treatment with a Pavlik harness or a spica cast for infants six months and younger with a diaphyseal femur fracture, because their outcomes are similar. Grade of Recommendation: Limited EARLY OR DELAYED SPICA CASTING Moderate evidence supports early spica casting or traction with delayed spica casting for children age six months to five years with a diaphyseal femur fracture with less than 2 cm of shortening. Grade of Recommendation: Moderate ELASTIC INTRAMEDULLARY NAILS Limited evidence supports the option for physicians to use flexible intramedullary nailing to treat children age five to eleven years diagnosed with diaphyseal femur fractures. Grade of Recommendation: Limited ORIF PEDIATRIC FEMUR FRACTURES Limited evidence supports rigid trochanteric entry nailing, submuscular plating, and flexible intramedullary nailing as treatment options for children age eleven years to skeletal maturity diagnosed with diaphyseal femur fractures, but piriformis or near piriformis entry rigid nailing are not treatment options. Grade of Recommendation: Limited PAIN CONTROL Limited evidence supports regional pain management for patient comfort peri- operatively. Grade of Recommendation: Limited WATERPROOF CASTING Limited evidence supports waterproof cast liners for spica casts are an option for use in children diagnosed with pediatric diaphyseal femur fractures. Grade of Recommendation: Limited v 2015 GUIDELINE REISSUE WORK GROUP Chair, AAOS Evidence-Based Quality and Value Committee: David S. Jevsevar, MD, MBA Vice Chair, Orthopaedics, Assistant Professor of Orthopaedic Surgery Dartmouth-Hitchcock Medical Center 1 Medical Center Drive Lebanon, NH 03756 Phone 630-650-5133 Guidelines Oversight Leader, AAOS Evidence-Based Quality and Value Committee: Kevin Shea, MD Intermountain Orthopaedics 600 N. Robbins Rd Ste 400 Boise, ID 83702 AAOS Staff (2015 Guideline Reissue) William Shaffer, MD AAOS Medical Director Deborah Cummins, PhD Director, Department of Research and Scientific Affairs Jayson Murray, MA Manager, Evidence-Based Medicine Unit Ben Brenton, MPH Research Analyst, Evidence-Based Medicine Unit Anne Woznica AAOS Medical Librarian Kaitlyn Sevarino Evidence-Based Quality and Value (EBQV) Coordinator Erica Linskey Administrative Assistant, Evidence-Based Medicine Unit vi 2007 GUIDELINE WORK GROUP Mininder S. Kocher, MD, MPH, Boston, MA 02115 Chair Children's Hospital James O Sanders, MD 300 Longwood Ave Department of Orthopaedics Orthopaedic Dept Rehabilitation University of Rochester Boston, MA 02115 601 Elmwood Avenue Rochester NY 14642 Ernest L. Sink, MD, Co-Chair The Children's Hospital Guidelines Oversight Chair: 13123 East 16th Ave B060 Aurora, CO 80045 William C. Watters, III MD 6624 Fannin #2600 R Dale Blasier, MD Houston, TX 77030 Dept of Orthopaedic Surgery 800 Marshall St Sturgis 363 Guidelines Oversight Vice-Chair: Little Rock, AR 72202 Michael J. Goldberg MD Scott J. Luhmann, MD Children’s Hospital and Regional St Louis Children's Hospital Medical Ctr. One Children's Pl Ste 4S 20 4800 Sand Point Way NE #w7706 Saint Louis, MO 63110 PO Box 5371 Seattle WA 98105-5371 Charles T. Mehlman, DO, MPH Children's Hospital Medical Center Evidence-Based Practice Committee 3333 Burnet Avenue, MLC 2017 Chair: Cincinnati, Ohio 45229-3039 Michael Warren Keith, MD David M. Scher, MD 2500 Metro Health Drive Hospital for Special Surgery Cleveland, OH 44109-1900 535 E 70th St 5th Fl New York, NY 10021 Travis Matheney, MD Children's Hospital Boston Orthopedic Surgery 47 Joy Street vii Former AAOS Staff (2007 Guideline) Robert H. Haralson III, MD, MBA Charles M. Turkelson, PhD Janet L. Wies, MPH Patrick Sluka, MPH Kristin Hitchcock viii Table of Contents 2015 Report for the ReIssue of the 2009 Clinical Practice Guideline on the Treatment of Pediatric Diaphyseal Femur Fractures ........................................................................................................................ i Overview of 2015 updates to the 2009 original guideline ........................................................................... i I. SUMMARY OF RECOMMENDATIONS ....................................................... III Child Abuse ................................................................................................................................................... v Infant Femur Fracture ................................................................................................................................. v Early or Delayed Spica Casting ................................................................................................................... v Elastic Intramedullary Nails........................................................................................................................ v ORIF Pediatric Femur Fractures ............................................................................................................... v Pain Control .................................................................................................................................................. v Waterproof Casting ...................................................................................................................................... v 2015 Guideline Reissue Work Group ........................................................................................................ vi 2007 Guideline Work Group ..................................................................................................................... vii TABLE OF CONTENTS ..................................................................................... IX LIST OF TABLES .............................................................................................. XII LIST OF FIGURES ............................................................................................ XII II. INTRODUCTION ........................................................................................... 1 Overview........................................................................................................................................................ 1 Goals and Rationale ..................................................................................................................................... 1 Intended Users .............................................................................................................................................. 1 Patient Population ........................................................................................................................................ 2 Incidence ....................................................................................................................................................... 2 Prevalence ..................................................................................................................................................... 2 Burden of Disease ......................................................................................................................................... 2 Etiology .......................................................................................................................................................... 2 ix