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Internal Fixation of Femoral Neck Fractures; Treatment and Effects Uitnodiging Internal Fixation of Femoral Neck Fractures; treatment and effects and treatment Neck Fractures; Femoral of Fixation Internal Uitnodiging Voor het bijwonen van de openbare verdediging van het proefschrift Internal Fixation of Femoral Neck Fractures; treatment and effects Internal Fixation of Femoral Neck Fractures; treatment and effects door Stephanie Zielinski Donderdag 21 mei 2015 Om 09.30 uur Senaatszaal Erasmus Universiteit Rotterdam Locatie Woudestein Burgemeester Oudlaan 50 Rotterdam Aansluitend bent u van harte uitgenodigd voor de receptie ter plaatse Paranimfen Casja Starink-Zielinski Nienke Dols Stephanie Zielinski Stephanie Stephanie Zielinski Stephanie Zielinski Bergse Linker Rottekade 80 3056 LC Rotterdam [email protected] Internal Fixation of Femoral Neck Fractures; treatment and effects Stephanie Zielinski Colofon ISBN: 978-94-6108-975-5 Copyright © 2015 S.M. Zielinski All rights reserved. No part of this thesis may be reproduced, stored in a retrieval system, or transmitted in any form or by any means without prior permission of the author or the copyright-owning journals for previously published chapters. Layout and printing: Gildeprint, Enschede, the Netherlands Grants: Part of the research described in this thesis was funded by grants from Fonds NutsOhra (grant number T-0602-43), The Netherlands Organization for Health Research and Development (ZonMw; grant number 171102008), Stichting Coolsingel (grant number 79), Physicians’ Services Incorporated Foundation (grant number 08-18), Canadian Institutes of Health Research (grant number 177466) and National Institutes of Health (grant number 1R01-AR055267-01A1). Printing of this thesis had been financially supported by: Internal Fixation of Femoral Neck Fractures; treatment and effects Interne fixatie van collum femorisfracturen; behandeling en effecten Proefschrift ter verkrijging van de graad van doctor aan de Erasmus Universiteit Rotterdam op gezag van de rector magnificus Prof.dr. H.A.P. Pols en volgens besluit van het College voor Promoties. De openbare verdediging zal plaatsvinden op 21 mei 2015 om 09.30 uur, door Stephanie Maria Zielinski geboren te Doetinchem Promotiecommissie Promotor Prof.dr. P. Patka Overige leden Prof.dr. M.H.J. Verhofstad Prof.dr. J.A.N. Verhaar Prof.dr. J.C. Goslings Copromotoren Dr. E.M.M. Van Lieshout Dr. M.J. Heetveld Voor Jouke (13 februari 1980 – 26 januari 2008) en Papa (22 mei 1948 – 15 juli 2008) Table of contents Chapter 1 Introduction 9 Part I Chapter 2 Central coordination as an alternative for per patient payment in a multicenter randomized controlled trial: the FAITH trial experience 21 Chapter 3 Surviving a site audit: tips for good clinical practice in an implant trial 39 Part II Chapter 4 Adherence to a femoral neck fracture treatment guideline 53 Chapter 5 Cumulative incidence and treatment of non-simultaneous bilateral femoral neck fractures in a cohort of 1,250 patients 67 Chapter 6 The societal costs of femoral neck fracture patients treated with internal fixation 81 Part III Chapter 7 Femoral neck shortening impairs gait velocity after internal fixation of a femoral neck fracture 99 Chapter 8 Functional outcome after successful internal fixation versus salvage arthroplasty of patients with a femoral neck fracture 117 Chapter 9 Implant removal after internal fixation of a femoral neck fracture: effects on physical functioning 131 Chapter 10 Physical therapy after discharge following internal fixation of femoral neck fractures: characteristics of treatment 145 Chapter 11 Summary and conclusions (English) 159 Chapter 12 Samenvatting en conclusies (Nederlands) 167 Chapter 13 General discussion 177 Appendix 1 Summary FAITH study protocol 187 Contributing authors 191 List of publications 197 Dankwoord 199 Curriculum vitae 203 PhD Portfolio 205 Chapter 1 Introduction Chapter 1 R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 R11 R12 R13 R14 R15 R16 R17 R18 R19 R20 R21 R22 R23 R24 R25 R26 R27 R28 R29 R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 10 Introduction Hip fractures are a major global health problem. They are associated with one year mortality R1 rates reported around 20 to 30% and a profound impairment of independence and quality of R2 life.1-3 Up to 50% of hip fracture patients do not rehabilitate to their pre-fracture ambulatory R3 or functional status.4,5 The disability adjusted life-years lost as a result of hip fractures ranks R4 in the top 10 of all cause disability globally.1 R5 The worldwide occurrence of hip fractures increased from an estimated 1.3 million R6 patients per year in 1990 to 1.6 million in 2000.1,6 In the Netherlands, the occurrence of hip R7 fractures has increased from 7,614 patients per year in 1981 to 21,000 in 2010.7,8 Despite R8 a declining trend of (age-adjusted) incidence in western countries, a worldwide increase in R9 total number of hip fractures is still expected as a result of increasing age-adjusted incidence R10 rates in developing countries and aging populations by improved global health care.8,9 R11 The health care costs associated with hip fracture care are considerable. Globally, the R12 annual estimated worldwide direct and indirect costs of hip fractures amounted to $34.8 R13 billion in 1990, and are expected to rise to an estimated $131 billion by 2050.10 In the R14 Netherlands, the total costs of hip fractures care amounted to € 378 million in 2007.11 This R15 was 0.5% of the total cost of Dutch health care, and 2.4% of the cost of Dutch hospital care R16 in 2007. R17 R18 The treatment of hip fracture patients is based upon the anatomical location of the fracture. R19 Hip fractures can be extracapsular (i.e., inter-/subtrochanteric) or intracapsular (i.e., R20 femoral head and neck). Approximately 50% of all hip fractures are intracapsular fractures R21 of the femoral neck.12 These fractures can be treated operatively with internal fixation or R22 arthroplasty. This thesis is focused on the treatment of femoral neck fracture patients with R23 internal fixation. R24 From meta-analyses it is known that internal fixation may lead to lower infection rates, R25 less blood loss, a shorter operative time, and possibly a decrease in mortality rate, compared R26 with arthroplasty. In contrast, arthroplasty significantly reduces the revision surgery rate, R27 which is an important advantage, as revision surgery rates of approximately 35% have been R28 reported after internal fixation failure.13-16 The main indications for revision surgery after R29 internal fixation are non-union, avascular necrosis of the femoral head, or implant failure. R30 The decision between internal fixation and arthroplasty is based upon patient characteristics R31 and fracture displacement (Figure 1). Patients with undisplaced fractures (i.e., Garden 1 or R32 2) should be treated with internal fixation.12 However, femoral neck fracture patients with R33 arthrosis, rheumatoid arthritis, or a pathologic fracture should be treated with arthroplasty, R34 as these conditions are contraindications for internal fixation. Elderly(i.e ., >80 years old) with R35 a displaced fracture (i.e; Garden 3 or 4) should receive arthroplasty. However, there is no clear R36 consensus on the treatment of younger patients with a displaced fracture.14,15,17-21 The general R37 opinion seems to be that internal fixation can be used in patients with limited comorbidity, R38 R39 11 Chapter 1 R1 who are mobile, independent, and not cognitively disabled pre-fracture. Patients for whom R2 the risk of revision surgery is considered too high should be treated with arthroplasty. These R3 evidence-based considerations on the treatment of femoral neck fractures were summarized R4 by the Association of Surgeons of the Netherlands (ASN/NVvH) in 2007 in an evidence-based R5 guideline on the treatment of elderly hip fracture patients.22 R6 R7 R8 R9 R10 R11 R12 R13 R14 R15 R16 Figure 1. Garden classification R17 R18 After internal fixation has been decided on, the type of implant has to be selected. R19 The dynamic hip screw (DHS) or multiple cancellous screws (CS) are still most commonly R20 used (Figure 2). Newer (usually angular stable) implants, such as the Targon® FN or the R21 dynamic locking blade plate (DLBP), are being investigated but are not used frequently R22 yet.23-25 Consensus on the preferred implant is currently lacking and surgical preference R23 may play a role.13,19 The international FAITH study (Fixation using Alternative Implants for R24 the Treatment of Hip fractures, NCT00761813) is aimed to resolve the debate on the best R25 implant for internal fixation of femoral neck fractures, comparing angular stable (DHS) versus R26 non-angular stable implants (CS). A summary of the aims and methods of the FAITH study is R27 provided in Appendix 1. Data from the Dutch FAITH study were used in this thesis to study R28 topics concerning internal fixation of femoral neck fracture patients, that have previously R29 received insufficient attention in the literature. R30 R31 R32 R33 R34 R35 R36 R37 R38 R39 12 Introduction R1 R2 R3 R4 R5 R6 R7 R8 R9 R10 R11 R12 R13 R14 R15 R16 R17 R18 Figure 2. Left: Dynamic Hip Screw (DHS), right: Cancellous Screws (CS) R19 R20 Aim of the thesis R21 The aim of this thesis was to analyze the extent to which the current treatment of femoral R22 neck fracture patients with internal fixation is uniform and in agreement with the national R23 guideline. The second aim was to study the effect of internal fixation on health care costs and R24 functional outcome. R25 R26 Randomized controlled trials (RCTs) are still relatively scarce in the orthopedic trauma R27 literature. This may be attributed to the logistical challenges of the implementation of RCTs. R28 Part 1 of this thesis is therefore focused on how to perform RCTs in trauma research.
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