Proefschrift

Permissive weight bearing in trauma patients with peri- and intra-articular fractures of the lower extremities Pishtiwan Hassan Shaker Kalmet

Permissive weight bearing in trauma patients with peri- and intra-articular fractures of the lower extremities

Colofon © Copyright Pishtiwan Kalmet, 2022 All rights reserved. No part of this book may be reproduced or transmitted in any form or by any means, without prior permission in writing by the author, or when appropriate, by the publishers of the publications. Cover design: Ilse Modder, grafisch ontwerper Layout: Tiny Wouters Production: Gildeprint ISBN: 978-94-6419-566-8 The work described in this thesis has received funding by the Netherlands Organization for Health Research and Development (ZonMW, project number 843001807). The insole material for this study was provided by the AO Foundation TK System (AOTK Project number: AO516.05). The funders had no role in the design and conduct of the study; in the collection, management, analysis and interpretation of the data; in the preparation, review, or approval of the manuscript; or in the decision to submit the manuscript for publication. Financial support by the Maastricht University for the publication of this thesis is gratefully acknowledged.

Permissive weight bearing in trauma patients with peri- and intra-articular fractures of the lower extremities PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit Maastricht, op gezag van de Rector Magnificus, Prof. dr. Pamela Habiboviđ, volgens het besluit van het College van Decanen, in het openbaar te verdedigen op donderdag 6 oktober 2022 om 13.00 uur door Pishtiwan Hassan Shaker Kalmet Geboren 25 december 1987 te Bagdad, Irak

Promotoren Prof. dr. P.R.G. Brink Prof. dr. M. Poeze Copromotor Dr. H.A.M. Seelen Beoordelingscommissie Prof. dr. J.A. Verbunt (voorzitter) Prof. dr. M.J.R. Edwards, Radboud Universitair Medisch Centrum, Nijmegen Prof. dr. J.H.B. Geertzen, Universitair Medisch Centrum, Groningen Prof. dr. A.F. Lenssen Dr. J.A. Ten Bosch

Table of contents Chapter 1 Introduction: permissive weight bearing in lower extremity fractures 7 Chapter 2 Outline of thesis 17 Chapter 3 Is the AO guideline for postoperative treatment of tibial plateau 23 fractures still decisive? A survey among orthopaedic surgeons and trauma surgeons in the Netherlands Chapter 4 The economic burden of the postoperative management in surgically 35 treated trauma patients with peri- and/or intra-articular fractures of the lower extremities: a prospective multicenter cohort study Chapter 5 A protocol for permissive weight bearing during allied health 49 therapy in surgically treated fractures of the pelvis and the lower extremities: the first experience in 150 patients Chapter 6 Patient-reported quality of life and pain after permissive weight 71 bearing in surgically treated trauma patients with tibial plateau fractures: a retrospective cohort study Chapter 7 Effectiveness of permissive weight bearing in surgically treated 83 trauma patients with peri- and intra-articular fractures of the lower extremities: a prospective comparative multicenter cohort study Chapter 8 Permissive weight bearing in surgically treated trauma patients 101 with peri- and/or intra-articular fractures of the lower extremities is cost-effective: a prospective comparative multicenter cohort study Chapter 9 General discussion 121 Summary 133 Samenvatting 137 Study impact 141 Appendix Dankwoord 147 List of publications 153 Curriculum vitae auctoris 157

Chapter 1 Introduction: Permissive weight bearing in lower extremity fractures Meys G Kalmet PHS Poeze M Seelen HAM Acute Medical Rehabilitation. Text book volume 2. 2019 Accepted for publication

Chapter 1 8

Introduction 9 Introduction A plethora of evidence is available about open reduction and internal fixation procedures in trauma patients with (peri)- or intra-articular fractures, as well as about the processes involved in bone healing.1,2 However, the subsequent rehabilitation treatment, or early aftercare, has been less systematically documented and is often based on empirical, implicit knowledge of individual medical or allied health therapists, acquired throughout many years of clinical practice. No formal evidence-based guidelines are available on the aftercare of surgically treated fractures. In view of this lack of evidence, many orthopaedic and trauma surgeons tend to advise conservatively with regard to weight bearing in rehabilitation, and hold on to the prevailing dogmas, i.e. recommending time-contingent progression of weight bearing, while physiotherapists and rehabilitation physicians may follow a more progressive approach towards fracture weight bearing. Besides, even with specific advice from specialists, patients may not always be committed to complying with non-weight bearing recommendations.3,4 It is remarkable that the recommendations for aftercare in patients surgically treated for fractures are still more or less the same as 60 years ago, without any sources of evidence being given for the advice.2,5 Furthermore, the lack of individual feedback on the actual weight bearing status causes great differences in weight bearing when the patient is advised restricted weight bearing.3,4,6 These circumstances give rise to a wide range of weight bearing patterns and inconsistent aftercare treatment.7,8 Biomechanical and animal studies indicate that early weight bearing is beneficial.9-11 Little is known about the relationship between fracture weight bearing during daily activities and the progression of consolidation of the fracture parts, the quality and function of the soft tissue, and biomechanical weight bearing capacity during the fracture healing. Fracture healing is an evolutionary well-developed complex process. One of the important factors influencing fracture healing is the amount of weight bearing of the involved limb. The speed with which the bone healing processes take place, together with the (aftercare) treatment provided, govern the progression with which weight bearing can be applied safely. Providing the adequate level of weight bearing on the fracture in a timely fashion during early aftercare treatment is considered essential in the speed towards full mobilisation.12-14 Both over-loading and under-loading may lead to a prolonged and complicated recovery (Figure 1.1). A certain minimum level of loading is necessary to elicit micromovements between adjacent bony fracture components, stimulating biological processes that enhance fracture consolidation and minimizing effects of immobilization. The upper boundary of the therapeutic bandwidth is determined by the mechanical stability of the fracture and the stabilization method used. Under-loading

Chapter 1 10 may lead to a host of problems such as loss of function, loss of muscle strength, loss of connective tissue’s loading capacity, persistent edema, osteoporosis due to inactivity, and loss of joint mobility.15,16 Over-loading is considered to increase the frequency of failure of osteosynthesis with mal-union and non-union. To clinically optimize fast recovery and advance restoration of function and functionality, one may want to set out a treatment that is near to the upper boundary of the therapeutic bandwidth, yet safe enough to avoid overloading. Also from a viewpoint of physiologic complexity and ageing, early recovery/rehabilitation is essential to ensure optimal outcome.17,18 Figure 1.1 Schematic overview of the consequences of loading on the fracture consolidation process. Clinicians prescribe non-weight bearing or partial weight bearing (restricted weight bearing (RWB) regimens) as standard treatment for peri-articular or intraarticular lower extremity fractures in an attempt to create an optimal protective mechanical environment at the different stages of healing. This strategy varies, based on the type of fracture, extent of the injury, and the preferences of the treating

Introduction 11 surgeon.19 For peri- or intra-articular fractures, the recommended protocols include 612 weeks of non-weight bearing, after which a gradual increase to full weight bearing is recommended.2 This restricted weight-bearing (RWB) strategy is thought to limit the forces at the fracture site and the implant and reduce the risk of mal-reduction. In light of the possible implications of early weight-bearing Haller et al. reviewed a number of studies investigating earlier weight bearing compared to standard, time-restraint weight bearing in tibial plateau, tibia plafond, ankle, and calcaneal fractures and found no increase in complication rate.20 Especially a number of randomized controlled trials in ankle fractures provide compelling evidence for early weight bearing although the early weight bearing groups received additional plaster immobilisation for stabilization. As reported in a randomized controlled trial dealing with fractures of the ankle joint, early weight bearing does not pose an undue risk of complications or worse patient outcomes compared to a non-weight bearing protocol.21 Furthermore, a meta-analysis shows that following ankle surgery early weight-bearing tends to accelerate return to work and daily activities compared to late weight-bearing without higher risk of complications.22 Postoperative rehabilitation for tibial plateau fractures most commonly involves a significant period of non-weight bearing before full weight bearing is recommended at 8-12 weeks. A study by Solomon shows that, in tibial plateau fractures, internal fixation with subchondral screws and a buttress plate provided adequate stability to allow immediate post-operative partial weight-bearing, without harmful consequences.23 Thus, the type of rehabilitation may be an important factor influencing recovery, necessitating future high quality prospective studies to determine the impact of different protocols on clinical and radiological outcomes.24 The standard aftercare treatment in surgically treated trauma patients with fractures of the tibial plateau features is non- or partial weight bearing.2 According to the Arbeitsgemeinschaft für Osteosynthesefragen (AO) principles of fracture management, postoperative management of (peri-) or intra-articular fractures of the lower extremities generally consists of toe-touch weight bearing for 6–12 weeks.2 As to fractures caused by extremely high energy impact, patients may need to adhere to toetouch weight bearing regimen for 10–12 weeks.2 On the other hand, a survey about the adherence of current RWB protocols showed that almost 90% of the surgeons do not follow these protocols standardly regarding the weight bearing aftercare for tibial plateau fractures.19 In addition, there is currently no consensus among surgeons worldwide with regard to early weight bearing versus restricted weight bearing in surgically treated trauma patients with fractures of the tibial plateau.19,25 High-quality clinical studies about early or permissive weight bearing (PWB) are scarce. Furthermore, to our knowledge there have been no studies on permissive weight bearing and its complications during rehabilitation from (peri)- or intra-articular fractures of the pelvis and lower extremities treated with internal fixation. Recent

Chapter 1 12 literature has reported composite postoperative complication rates of up to 37% in non-weight bearing.26-35 To optimize recovery with a minimal complication rate, it might be useful to use a treatment that is near the upper boundary of the therapeutic bandwidth, yet safe enough to avoid overloading, essentially the goals of the permissive weight bearing protocol. Permissive weight bearing Permissive weight bearing is a comprehensive protocol during rehabilitation and evaluation of surgically treated lower extremity fractures. This should enable a more systematic monitoring and guidance of the aftercare, based on patients’ individual characteristics, characteristics of the surgically treated fractures, verifiable evidencebased criteria related to healing processes of surgically treated fractures, therapeutic milestones that may be set, indicators of progress that can be identified and evidence for the prevention of complications. In an early aftercare treatment regimen for an individual patient with a surgically treated fracture of a lower extremity, rehabilitation specialists or therapists should address and/or systematically monitor several issues: a) Which realistic treatment outcomes may be aimed for, given the patient’s specific fracture? b) How fast is the specific fracture consolidating in this patient? c) How fast does weight bearing capacity develop during bone healing, as this is essential in determining the pace at which training intensity may be safely increased? d) What kind of complications may be expected during the recovery process, which must be carefully monitored in order to take effective early counteractive measures? Conclusion One of the main reasons for developing a systematic and comprehensive protocol has been the fact that, despite major improvements in surgical treatment and osteosynthesis materials, rehabilitation after surgical treatment of fractures has remained almost unchanged over the last six decades. The permissive weight bearing protocol has been developed in close cooperation between rehabilitation specialists, physical therapists and (orthopedic) trauma surgeons. It should serve as a general reference framework and a starting point for a discussion of the systematic optimization of the rehabilitation in patients with surgically treated fractures of the lower extremities, rather than as a library of predefined standard solutions

Introduction 13 (‘cookbook’). To optimize recovery with a minimal complication rate, it is recommended to use a treatment that is near the upper boundary of the therapeutic bandwidth, yet safe enough to avoid overloading, and that such treatment is guided by the permissive weight bearing protocol. Permissive weight bearing is a patient-tailored protocol. The protocol might be eligible for implementation in the treatment of trauma patients with surgically treated articular or (peri)- or intra-articular fractures of the pelvis and lower extremities.

Chapter 1 14 References 1. AO_Foundation. Available from: https://surgeryreference.aofoundation.org. 2021. 2. Thomas P, Ruedi RE, Buckley CG, Moran. AO Principles of Fracture Management. Thieme, New York. 2007. 3. Gray FB, Gray C, McClanahan JW. Assessing the accuracy of partial weight-bearing instruction. Am J Orthop (Belle Mead NJ).1998;27:558-60. 4. Hurkmans HL, Bussmann JB, Selles RW et al. The difference between actual and prescribed weight bearing of total hip patients with a trochanteric osteotomy: long-term vertical force measurements inside and outside the hospital. Arch Phys Med Rehabil. 2007;88:200-6. 5. Muller ME, Allgower M, Schneider R, Willenegger. Manual of Internal Fixation Techniques.Springer, Berlin. 1977. 6. Hustedt JW, Blizzard DJ, Baumgaertner MR et al. Is it possible to train patients to limit weight bearing on a lower extremity? Orthopedics. 2012;35:e31-7. 7. Westby MD, Backman CL. Patient and health professional views on rehabilitation practices and outcomes following total hip and knee arthroplasty for osteoarthritis: a focus group study. BMC Health Serv Res. 2010;10:119-33. 8. Westby MD, Brittain A, Backman CL. Expert consensus on best practices for post-acute rehabilitation after total hip and knee arthroplasty: a Canada and United States Delphi study. Arthritis Care Res.2014;66:411-23. 9. Bailon-Plaza A, van der Meulen MC. Beneficial effects of moderate, early loading and adverse effects of delayed or excessive loading on bone healing. J Biomech. 2003;36:1069-77. 10. Claes LE, Heigele CA, Neidlinger-Wilke C et al. Effects of mechanical factors on the fracture healing process. Clin Orthop Relat Res. 1998:S132-47. 11. Gardner MJ, van der Meulen MC, Demetrakopoulos D et al. In vivo cyclic axial compression affects bone healing in the mouse tibia. J Orthop Res. 2006;24:1679-86. 12. Oldmeadow LB, Edwards ER, Kimmel LA et al. No rest for the wounded: early ambulation after hip surgery accelerates recovery. ANZ J Surg. 2006;76:607-11. 13. Augat P, Simon U, Liedert A, Claes L. Mechanics and mechano-biology of fracture healing in normal and osteoporotic bone. Osteoporos Int. 2005;16:S36-43. 14. MĂǀēŝē ͕ ŶƚŽůŝē s͘ KƉƚŝŵĂů ŵĞĐŚĂŶŝĐĂů ĞŶǀŝƌŽŶŵĞŶƚ ŽĨ ƚŚĞ ŚĞĂůŝŶŐ ďŽŶĞ ĨƌĂĐƚƵƌĞͬŽƐƚĞŽƚŽŵLJ͘ /Ŷƚ Orthop. 2012;36:689-95. 15. Westerman RW, Hull P, Hendry RG, Cooper J. The physiological cost of restricted weight bearing. Injury. 2008;39:725-7. 16. de Morree JJ. Dynamics of human connective tissue [Dynamiek van het menselijk bindweefsel]. Houten, the Netherlands: Bohn Stafleu van Loghum. 2009. 17. Goldberger AL, Peng CK, Lipsitz LA. What is physiologic complexity and how does it change with aging and disease? Neurobiol Aging. 2002;23:23-6. 18. Manor B, Lipsitz LA. Physiologic complexity and aging: implications for physical function and rehabilitation. Prog Neuropsychopharmacol Biol Psychiatry. 2013;45:287-93. 19. ǀĂŶ ĚĞƌ sƵƐƐĞ D͕ <ĂůŵĞƚ W,^͕ ĂƐƚŝĂĞŶĞŶ ,' Ğƚ Ăů͘ Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? A survey among orthopaedic surgeons and trauma surgeons in the Netherlands. Arch Orthop Trauma Surg. 2017;137:1071-5. 20. Haller JM, Potter MQ, Kubiak EN. Weight bearing after a periarticular fracture. What is the evidence? Orthop Clin N Am. 2013;44:509-19. 21. ^ǁĂƌƚ ͕ ĞnjŚĂŶŝ ,͕ 'ƌĞŝƐďĞƌŐ :͕ sŽƐƐĞůůĞƌ :d͘ How long should patients be kept non-weight bearing after ankle fracture fixation? A survery of OTA and AOFAS members. Injury. 2015;46:1127-30. 22. Smeeing DP, Houwert RM, Briet JP et al. Weight-bearing and mobilization in the postoperative care of ankle fractures: a systematic review and meta-analysis of randomized controlled trials and cohort studies. PLoS One. 2015;10:0118320. 23. Solomon LB, Callary SA, Stevenson AW et al. Weight-bearing-induced displacement and migration over time of fracture fragments following split depression fractures of the lateral tibial plateau: a case series with radiostereometric analysis. J Bone Joint Surg Br. 2011;93:817-23.

Introduction 15 24. Arnold JB, Tu CG, Phan TM et al. Characteristics of postoperative weight bearing and management protocols for tibial plateau fractures: Findings from a scoping review. Injury. 2017;48:2634-42. 25. Kubiak EN, Beebe MJ, North K et al. Early weight bearing after lower extremity fractures in adults. J Am Acad Orthop Surg. 2013;21:727-38. 26. Choo KL, Morshed S. Postoperative complications after repair of tibial plateau fractures, J Knee Surg. 2014;27:11-9. 27. Koval KJ, Gilbert MS, Cornwall R. Functional outcomes and mortality vary among different types of hip fractures: a function of patient characteristics. Clin Orthop Relat Res. 2004;425:64-71. 28. Dong-Hyun LM, Keun-Bae L, Sung-dĂĞŬ :͘ ŽŵƉĂƌŝƐŽŶ ŽĨ ĂƌůLJ sĞƌƐƵƐ ĞůĂLJĞĚ tĞŝŐŚƚďĞĂƌŝŶŐ KƵƚĐŽŵĞƐ After Microfracture for Small to Midsized Osteochondral Lesions of the Talus. Am J Sports Med. 2012;40:2023-8. 29. Hulsker CC, Kleinveld S, Zonnenberg CB et al. Evidence-based treatment of open ankle fractures. Arch Orthop Trauma Surg. 2011;131:1545-53. 30. Halvorson JJ, Winter SB, Teasdall RD et al. Talar Neck Fractures: A Systematic Review of the Literature. J Foot Ankle Surg. 2013;52:56-61. 31. Lasanianos NG, Lyras DN, Mouzopoulos G et al. Early mobilization after uncomplicated medial subtalar dislocation provides successful functional results. J Orthop Traumatol. 2011;12:37-43. 32. Mario Cala KB, Hany J. Early mobilization in bilateral talar fractures. The Foot and Ankle Online J. 2014;7:9. 33. Yu X, Pang QJ, Chen L et al. Postoperative complications after closed calcaneus fracture treated by open reduction and internal fixation: a review. J Int Med Res. 2014;42:17-25. 34. ^ĐŚǁĂďĞ W͕ tŝĐŚůĂƐ &͕ ƌƵƐĐŚĞů Ğƚ Ăů͘ <ŽŵƉůŝŬĂƚŝŽŶĞŶ ŶĂĐŚ ŽƐƚĞŽƐLJŶƚŚĞƚŝƐĐŚĞƌ sĞƌƐŽƌŐƵŶŐ ǀŽŶ Azetabulumfrakturen [Complications after osteosynthetic treatment of acetabular fractures]. Orthopäde. 2014;43:24-34. 35. Papakostidis C, Kanakaris NK, Kontakis G et al. Pelvic ring disruptions: treatment modalities and analysis of outcomes. Int Orthop. 2009;33:329-38.

Chapter 1 16

Chapter 2 Outline of thesis

Chapter 2 18

Outline of thesis 19 This thesis describes the current state of practice among surgeons and cost-of-illness regarding non- or restricted weight bearing (RWB) (current guidelines), a comprehensive protocol for permissive weight bearing (PWB) and the (cost-) effectiveness of permissive weight bearing versus non- or restricted weight bearing. The permissive weight bearing concept has been introduced in chapter 1, while the non- or restricted weight bearing protocol is the current guideline in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities. However, as found in chapter 1, there are no studies done investigating the use of the permissive weight bearing protocol in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities. The permissive weight bearing protocol might be beneficial and has potential to be implemented in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities. Therefore, the purposes of the thesis were to describe the current state of practice among surgeons and the economic impact regarding non- or restricted weight bearing, a comprehensive protocol for permissive weight bearing and the (cost-) effectiveness of permissive weight bearing versus non- or restricted weight bearing. The hypothesis of this thesis is that the permissive weight bearing protocol in surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities is more effective and cost-effective compared to the non- or restricted weight bearing protocol. Furthermore, the rate of complications (e.g. failure of osteosynthesis, secondary displacement of fracture parts, non-union, infections) is equal or lower in patients who are treated according to the permissive weight bearing protocol compared to patients treated according the non- or restricted weight bearing protocol. The following research objectives were formulated: 1. To investigate the current state of practice among orthopaedic surgeons and trauma surgeons in choosing the criteria and the time period of restricted weight bearing after surgically treated tibial plateau fractures. 2. To determine the economic impact of the (after)care in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities 3. To describe a comprehensive protocol for permissive weight bearing during allied health therapy and to report on both the time to full weight bearing and the number of complications in patients with surgically treated fractures of the pelvis and lower extremities who undergo permissive weight bearing. 4. To compare quality of life and pain, and number of complications in patients with surgically treated tibial plateau fractures who followed a permissive weight bearing regime, relative to those that followed a restricted weight bearing regime. 5. To determine the effectiveness of the permissive weight bearing protocol compared with respect to early recovery (during first 6 months) of functional

Chapter 2 20 outcome in trauma patients with peri- and intra-articular fractures of the lower extremities, compared to a non- or restricted weight bearing protocol. 6. To compare the cost-effectiveness and the cost-utility of the permissive weight bearing protocol to that of the non- or restricted weight bearing protocol, being care as usual. These six research objectives were addressed in the subsequent chapters of this thesis. As described in the introduction, rapid clinical recovery, the restoration of function and functionality and low complication rates are considered the most important conditions for using an early or permissive weight bearing protocol in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities. In chapter 3 of this thesis, the objective was to investigate the current state of practice among orthopaedic surgeons and trauma surgeons in choosing the criteria and the time period until weight bearing after surgically treated tibial plateau fractures. A web-based survey was distributed among members of the Dutch Trauma Society and Dutch Orthopaedic Society to identify the most commonly applied protocols in terms of the post-operative initiation and level of weight bearing in patients with tibial plateau fractures. The aim of the study in chapter 4 was to determine the economic impact of the (after)care of peri- and intra-articular fractures in the lower extremity, based on a prospective prevalence-based cohort study from health care and societal perspective. Surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities following a non- or restricted weight bearing protocol were included. This study was an economic burden study focusing on costs (in euros), Activities of Daily Living (ADL) as measured with the Lower Extremity Functional Scale (LEFS) and the Quality of Life (Qol) as measured with the EuroQol 5-Level EQ-5D (EuroQol) during 26 weeks follow-up. In chapter 5, the aim of the study was to describe a comprehensive protocol for permissive weight bearing during allied health therapy and to report on the time to full weight bearing as well as the number of complications in patients with surgically treated fractures of the pelvis and lower extremities undergoing permissive weight bearing. This study included surgically treated trauma patients with (peri)- and/or intraarticular fractures of the pelvis and lower extremities. A standardized permissive weight bearing protocol was used for all patients. Time to full weight bearing and number of complications were recorded. In a retrospective cohort study (chapter 6) the aim was to inventory potential differences in quality of life and pain, and number of complications in patients with

Outline of thesis 21 surgically treated tibial plateau fractures who followed a permissive weight bearing regime, relative to those that followed a restricted weight bearing regime. This study included surgically treated trauma patients with tibial plateau fractures, who underwent rehabilitation according to permissive weight bearing or restricted weight bearing between 2005-2015. In chapter 7 and 8, the effectiveness (chapter 7) and cost-effectiveness (chapter 8) of the permissive weight bearing protocol in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities were compared to those that followed a non- or restricted weight bearing protocol. This prospective multicenter comparative cohort study included surgically treated trauma patients with peri- and intra-articular fractures of the lower extremities using permissive weight bearing and restricted weight bearing groups regimens.

Chapter 2 22

Chapter 3 Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? A survey among orthopaedic surgeons and trauma surgeons in the Netherlands van der Vusse M Kalmet PHS Bastiaenen CHG van Horn YY Brink PRG Seelen HAM Arch Orthop Trauma Surg. 2017;137(8):1071-1075

Chapter 3 24 Abstract Introduction The standard aftercare treatment (according to the Arbeitsgemeinschaft für Osteosynthesefragen (AO) guideline) for surgically treated trauma patients with fractures of the tibial plateau is non-weight bearing or partial weight bearing for 10-12 weeks. The purpose of this study was to investigate the current state of practice among orthopaedic surgeons and trauma surgeons in choosing the criteria and the time period of restricted weight bearing after surgically treated tibial plateau fractures. Materials and methods A web-based survey was distributed among members of the Dutch Trauma Society and Dutch Orthopaedic Society to identify the most commonly applied protocols in terms of the post-operative initiation and level of weight bearing in patients with tibial plateau fractures. Results One hunderd and eleven surgeons responded to the survey. 72.1% of the respondents recommended starting weight bearing earlier than the 12 weeks recommended by the AO guideline; 11.7% recommended starting weight bearing immediately, 4.5% after 2 weeks and 55.9% after 6 weeks. Moreover, 88.7% of the respondents reported deviating from their own local protocol. There is little consensus about the definition of 100% weight bearing and how to build up weight bearing over time. Conclusion This study demonstrates that consensus about the weight bearing aftercare for tibial plateau fractures is limited. A large majority of surgeons do not follow the AO guideline or their own local protocol. More transparent criteria and predictors are needed to design optimal weight-bearing regimes for the aftercare of tibial plateau fractures.

Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? 25 Introduction The incidence of tibial plateau fractures is approximately 13.3 per 100,000 persons.1 The postoperative management of these surgically treated fractures in trauma patients is of the utmost importance for a full recovery of knee function and the patient’s participation in daily activities and work. Tibial plateau fractures are a cause of longterm disability and pain, and frequently lead to many weeks off work, with substantial economic effects. The standard aftercare treatment in surgically treated trauma patients with fractures of the tibial plateau is non-weight bearing or partial weight bearing.2 According to the AO Principles of Fracture Management, postoperative management of tibial plateau fractures consists of generally maintained on toe-touch weight bearing for 6–8 weeks. Exceptions are fractures caused by extremely high energy; these patients might need to adhere to toe-touch weight bearing for 10–12 weeks.3 However, there is currently no worldwide consensus among surgeons with regard to permissive weight bearing versus restricted weight bearing in surgical trauma patients with fractures of the tibial plateau.4 Permissive weight bearing might be early weight bearing, but this not the goal as such. In permissive weight bearing the patient dictates the progress in weight bearing together with the physiotherapist. Although biomechanical and animal studies suggest that early weight bearing is beneficial,5-7 there have been virtually no high-quality clinical studies comparing permissive weight bearing (PWB) with restricted weight bearing (RWB) after surgically treated tibial plateau fractures. The purpose of the present survey was to investigate the current state of postoperative practice among Dutch orthopaedic surgeons and trauma surgeons regarding patients with surgically treated tibial plateau fractures. The survey asked whether they adhered to the AO guideline and their own local guidelines and which criteria they used to decide when and at what level to start weight bearing after surgery. Materials and methods A web-based survey was developed by the authors and was distributed among Dutch orthopaedic surgeons and trauma surgeons, using online software (www.formdesk.nl). The survey was publicised at the Dutch trauma congress in 2013 and placed on the websites of the Dutch Trauma Society and the Dutch Orthopaedic Society. Together,

Chapter 3 26 the two societies comprise 1293 members. In addition, we approached the surgeons through direct email at their hospital departments in the period of November 2013 – October 2014. The survey consisted of twelve questions, shown in Table 1.1. Statistical analysis Statistical analysis was performed using IBM SPSS Statistics, Version 21.0, Armonk, NY. Descriptive statistics were used to describe the demographic data and baseline characteristics of the entire survey. Results are presented as either mean ± standard deviation (SD) or as frequencies and percentages. Table 3.1 The questionnaire. 1) What is your discipline? 2) How long have you been a surgeon? 3) How often do you operate a tibial plateau fracture on yearly basis? 4) When do you start aftercare weight bearing in patients with tibial plateau fractures and with which weight bearing percentage? 5) Do you occasionally deviate from the standard postoperative protocol used in your clinic? 6) If you deviate from the standard protocol, on which factors is your decision based? 7) Which criteria do you use to determine earlier or delayed weight bearing? 8) How do you define 100% weight bearing? 9) How do you (gradually) increase postoperative weight bearing? 10) What kind of early complications do you see in patients with tibial plateau fractures in your clinic? 11) Are these complications related to early weight bearing? 12) Do you see yourself as a surgeon who is a more conservative or more progressive in the aftercare of tibial plateau fractures? Results Of the 111 surgeons who responded in the survey, 61 (55.0%) were orthopaedic surgeons and 50 (45.0%) were trauma surgeons. The overall response rate was 8.6% (i.e. 111/1293). Thirty-eight (34.2%) of the respondents were for 0-5 years surgeon, N=21 (19.0%) 5-15 years and N=52 (46.8%) more than 15 years surgeon. On yearly basis, N=44 (39.6%) operated less than 5 times a tibial plateau fracture, N=51 (46.0%) between 5-10 times and N=16 (14.4%) more than 10 times per year. Surgeons were asked when they started weight bearing after surgical treatment of tibial plateau fractures and with which weight bearing percentage. The results are shown in Figure 3.1: 11.7% of the respondents started immediately with weight bearing, 4.5% after 2 weeks, while the majority (55.9%) recommended starting weight bearing 6 weeks post-operatively. Only 15.3% recommended weight bearing after 12 weeks, i.e. in line with the AO guideline. Furthermore, 12.6% of the respondents

Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? 27 recommended that the start of weight bearing should depend on the type of fracture and the osteosynthesis material. These findings imply that 72.1% of the respondents recommended starting weight bearing earlier than the 12-week period recommended by the AO guideline. Figure 3.1 When do you start weight bearing after tibial plateau fractures and with what weight bearing percentage? Figure 3.2 shows that 88.7% of the respondents occasionally deviated from their local standard protocol, in most cases based on clinical experience (38.7%) and gut feeling (35.1%), while 19.8% of the respondents deviated on the basis of so-called evidence-based medicine, even though the latter is scarce in the literature. Figure 3.2 Reasons for deviating from own standard local protocol.

Chapter 3 28 Frequently mentioned reasons for starting weight bearing earlier or later were fracture type [N=87 (78.4%) and N=83 (74.8%), respectively], certainty or uncertainty of fixation quality [N=66 (59.5%) and N=74 (66.7%), respectively], age [N=46 (41.4%) and N=38 (34.2%), respectively] and additional traumata [N=0 (0.0%) and N=50 (45%), respectively]. The two most important influencing aspects to bear weight earlier or later is the type of fracture and the certainty or uncertainty of fixation, (Figure 3.3). Figure 3.3 Which criteria are used to decide earlier or later weight bearing? Surgeons who recommended starting weight bearing immediately or after 2 weeks mostly commenced with a low dosage (10%-25%) of weight bearing (Table 3.2). If weight bearing started 6 weeks post-operatively, this was mainly at 50% (27 respondents) or 10%-25% (21 respondents) of the maximum level. When patients started weight bearing 12 weeks after the surgical treatment, 10 out of 11 surgeons recommended starting immediately with 100% weight bearing. Since it is important to know what surgeons regard as “100% weight bearing”, we asked for their definition of “100% weight bearing”, results of which are shown in Figure 3.4. The majority, i.e. 45 (40.5%) respondents, defined this as “walking without crutches”, 35 (31.5%)

Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? 29 respondents indicated “standing on one leg of the affected side”, 20 (18.0%) respondents mentioned “walking with crutches” and 10 (9.0%) respondents considered “100% weight bearing” to be “running, jumping, climbing a staircase”. Table 3.2 Level of weight bearing (percentage) patients are allowed to start with. Maximal weight bearing (%) Direct/Early weight bearing After 2 weeks After 6 weeks After 12 week (AO-guideline) Depends on type # and OSM 10-25% 10 4 21 0 0 50% 1 0 27 1 0 75% 0 0 1 0 0 100% Weight bearing without % 1 0 7 6 14 Total 13 5 62 17 14 # = fracture; OSM = osteosynthesis material Figure 3.4 Definition of “100% weight-bearing” used by surgeons. Most surgeons (N=48, 43.2%) told their patients that weight bearing should increase gradually over a fixed number of weeks, expressed in kilograms or percentage of body weight. Twenty-nine (26.0%) surgeons recommended gradually increasing weight over a fixed number of weeks to a level of 100%, based on how much weight bearing the patient could tolerate. Twenty-nine (26.0%) surgeons recommended permissive weight bearing, which means surgeons let patients and therapists decide how to build up the weight bearing as tolerated (Figure 3.5). Of the 29 (26.0%) respondents who recommended permissive weight bearing, N=12 (10.8%) were orthopaedics and N=17 (15.3%) were trauma surgeons. Eight (7.2%) respondents who recommended permissive weight bearing had a work experience of 0-5 years, N=14 (12.6%) 5-15 years and N=7 (6.3%) more than 15 years. In this group N=9 (8.1%)

Chapter 3 30 operated less than 5 times, N=16 (14.4%) between 5-10 times and N=4 (3.6%) more than 10 times. Fifty-three (47.7%) of the respondents were conservative in the aftercare of tibial plateau fractures and N=58 (52.3%) were progressive in the aftercare. Figure 3.5 How do surgeons advise their patients about increasing weight bearing following a graded protocol? A: Graded increase over time in a fixed number of weeks, expressed in kilogram or percentage of body weight B: Graded increase over a fixed number of weeks, expressed as as much weight bearing as tolerated by the patient C: Permissive weight bearing, which means surgeons let patients and therapists decide how to build up the weight bearing as tolerated D: Other. Discussion This survey is an attempt to obtain up-to-date information on the time period between surgical treatment of tibial plateau fractures and the start of rehabilitation involving weight bearing. The AO guideline for postoperative management of tibial plateau fractures was formulated about 50 years ago and suggests restricted weight bearing for approximately 12 weeks.3 It is generally assumed that orthopaedic surgeons and trauma surgeons follow the AO guideline, advocating restricted weight bearing during aftercare for the patients. Interestingly, the present study shows that a large proportion of orthopaedic surgeons and trauma surgeons in the Netherlands recommended starting weight bearing earlier than 12 weeks. In practice, the vast majority of the responding surgeons deviated from their own institutional guidelines, based on clinical experience and gut feeling, thus deviating from the AO guideline.

Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? 31 The period of delayed weight bearing was reported to depend, inter alia, on the fracture type, certainty or uncertainty about fixation quality and additional traumata. To date, we have not been able to identify studies providing methodologically sound evidence as to critical factors that may assist in the decision to start weight bearing earlier or later. However, many studies have shown a trend towards favouring earlier weight bearing. Longer-term outcomes have also been described in the literature, with no negative effects of early weight bearing being reported.8-13 It is important to note that this study did not intend to determine the optimal aftercare for a given tibial plateau fracture, but was designed to disclose the current practice regarding tibial plateau fracture surgery aftercare and the factors on which orthopaedic surgeons and trauma surgeons found their decisions. This study clearly demonstrates that there is as yet no consensus about the aftercare of tibial plateau fractures. Furthermore, there is no evidence to restrict patients in bearing weight for 10-12 weeks as suggested by the AO guideline. Our findings show that at least in the Netherlands, the AO guideline is not decisive. In addition, we found large variations in post-operative rehabilitation treatment. It should be kept in mind that another complicating factor could be lack of patient compliance with prescribed rehabilitation aftercare.14,15 A number of studies reported that patients often exceeded the prescribed level of partial weight bearing, even when self-reported compliance was high.16 Thus, despite the expressed willingness to comply, patients often do not follow the restrictions on weight bearing and increase their weight bearing as fracture healing progresses. Together with the finding that there is no consensus as to what the definition of “100% weight bearing” is and how to build up weight in a protocolled way, our study revealed a large diversity in practical weight bearing usage among surgeons. This makes it even more difficult to achieve a good interpretation of the aftercare and offer customized advice to patients regarding the optimal aftercare in terms of weight bearing during the rehabilitation. There are a few important limitations of this study. The study is limited by the response rate. The survey didn’t describe the different types of fractures and assumptions regarding the energy of trauma. Furthermore, it is important to note that this study does not attempt to describe what the correct aftercare treatment is in tibial plateau fractures, but rather to obtain up-to-date information on the time period between surgical treatment of tibial plateau fractures and the start of rehabilitation involving weight bearing. In summary, the outcome of this survey shows that there is no clear consensus about optimal postoperative treatment of patients with a tibial plateau fracture, which may result in suboptimal rehabilitation aftercare. This leaves open the question what is the optimal rehabilitation treatment in surgically treated

Chapter 3 32 tibial plateau fractures. To answer this question, the authors recommend that both the AO guideline and current local institutional guidelines should be critically scrutinized to establish the optimal aftercare for these patients. In theory, it is normally the surgeon who decides which aftercare protocol should be followed. Most often, this is a restricted weight-bearing regime with a build-up time over a fixed number of weeks. In practice, such protocols are not followed very strictly. As 26% of the respondents would like to advocate using a customized permissive weight bearing protocol, as well as studies by Solomon et al and Segal et al which support individualized permissive weight bearing.13,17 However, high-quality prospective studies are needed to help identify which criteria and predictive factors are important for developing a (permissive) weight bearing protocol to optimize patients’ comfort and optimize the course of recuperation. Conclusion This study demonstrates that consensus about the weight bearing aftercare for tibial plateau fractures is limited. A large majority of surgeons do not follow the AO guideline or their own local protocol. More transparent criteria and predictors are needed to design optimal weight-bearing regimes for the aftercare of tibial plateau fractures.

Is the AO guideline for postoperative treatment of tibial plateau fractures still decisive? 33 References 1. Court-Brown CM, Caesar B. Epidemiology of adult fractures: A review. Injury. 2006;37(8):6917. 2. Haller JM, Kubiak EN. Weight bearing after a periarticular fracture: what is the evidence? Orthopedic Clinics of North America. 2013; 44(4):509–19. 3. Rüedi TP, Buckley RE, Moran CG. AO Principles of Fracture Management. 2007; 2nd edition(New York: Thieme): 832. 4. Kubiak EN, Beebe MJ, North K et al. Early weight bearing after lower extremity fractures in adults. J Am Acad Orthop Surg. 2013;21(12):727-38. 5. Bailon-Plaza A, van der Meulen MC. Beneficial effects of moderate, early loading and adverse effects of delayed or excessive loading on bone healing. J Biomech. 2003;36(8):1069-77. 6. Claes LE, Heigele CA, Neidlinger-Wilke C et al. Effects of mechanical factors on the fracture healing process. Clin Orthop Relat Res. 1998;S132-47. 7. Gardner MJ, van der Meulen MC, Demetrakopoulos D et al. In vivo cyclic axial compression affects bone healing in the mouse tibia. J Orthop Res. 2006;24(8):1679-86. 8. Kutzner I, Heinlein B, Graichen F et al. Loading of the knee joint during activities of daily living measured in vivo in five subjects. J Biomech. 2010;43(11):2164–73. 9. Brown TD, Anderson DD, Nepola JV et al. Contact stress aberrations following imprecise reduction of simple tibial plateau fractures. J Orthop Res. 1988;6:851–62. 10. Solomon LB, Callary SA, Stevenson AW et al. Weight-bearing-induced displacement and migration over time of fracture fragments following split depression fractures of the lateral tibial plateau: a case series with radiostereometric analysis. J Bone Joint Surg Br. 2011;93(6):817-23. 11. Canadian Orthopaedic Trauma S. Open reduction and internal fixation compared with circular fixator application for bicondylar tibial plateau fractures. Results of a multicenter, prospective, randomized clinical trial. J Bone Joint Surg Am. 2006;88(12):2613-23. 12. Westerman RW, Hull P, Hendry RG, Cooper J. The physiological cost of restricted weight bearing. Injury. 2008;39(7):725-7. 13. de Morree JJ. Dynamics of human connective tissue. 2009, Houten, the Netherlands: Bohn Stafleu van Loghum. 14. Hurkmans HL, Bussmann JB, Selles RW et al. The difference between actual and prescribed weight bearing of total hip patients with a trochanteric osteotomy: Long-term vertical force measurements inside and outside the hospital. Arch Phys Med Rehabil. 2007;88: 200-6. 15. Hustedt JW, Blizzard DJ, Baumgaertner MR et al. Is it possible to train patients to limit weight bearing on a lower extremity? Orthopedics. 2012;35: e31-e37. 16. Warren CG, Lehmann JF. Training procedures and biofeedback methods to achieve controlled partial weight bearing: an assessment. Arch Phys Med Rehabil. 1975;56(10):449-55. 17. Segal D, Mallik AR, Wetzler MJ et al. Early weight bearing of lateral tibial plateau fractures. Clin Orthop Relat Res. 1993;(294):232-7.

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Chapter 4 The economic burden of the postoperative management in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities: a prospective multicenter cohort study Kalmet PHS Andriessen MT Maduro CV van den Boom NAC Moens-Oyen CPA Hiligsmann MJC Janzing H van der Veen A Jaspars C Sintenie JB Seelen HAM Brink PRG Poeze M Evers SMAA Injury. 2022;53(2):713-718

Chapter 4 36 Abstract Objectives To estimate the economic burden expressed in costs and quality of life of the postsurgical treatment of peri- and/or intra-articular fractures in the lower extremity from a societal perspective. Design and setting This is a quantitative study as it aims to find averages and generalize results to wider populations. The design is a cost–of-illness and quality of life study focusing on costs (in euros), Activities of Daily Living (ADL) and Quality of Life (Qol) in patients with peri- and/or intra-articular fractures of the lower extremities. Surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities during 26 weeks follow-up. Patients were included from 4 hospitals in the Netherlands. Main outcome measures Costs, ADL and Quality Adjusted Life Years (QALY). Methods Cost of illness was estimated through a bottom-up method. The Dutch EQ-5D-5L questionnaire was used to calculate utilities while Lower Extremity Functional Scale (LEFS) scores were used as a measure of ADL. Non-parametric bootstrapping was used to test for statistical differences in costs. Subgroup analyses were performed to determine the influence of work status and further sensitivity analyses were performed to test the robustness of the results. Results Total average societal costs were € 9,836.96 over six months. Unexpectedly, total societal and healthcare costs were lower for patients with a paid job relative to patients without. Sensitivity analyses showed that our choice of a societal perspective and the EuroQol as our primary utility measurement tool had a significant effect on the outcomes. The ADL at baseline was 10.4 and at 26 weeks post-surgery treatment 49.5. The QoL was at baseline 0.3 and at 26 weeks post-surgery treatment 0.7. These findings are indicative of a significantly improved ADL and QoL (p<0.05) over time. Conclusions This study revealed a substantial economic burden in monetary terms and effect on QoL of patients with peri- and/or intra-articular fractures of the lower extremities during 26 weeks follow-up.

Economic burden of the postoperative management in peri- and/or intra-articular fractures of the lower extremities 37 Introduction Every year, millions of people with a fracture of the lower extremities are treated in emergency rooms all over the world.1 In the Netherlands, approximately 15,000 trauma patients undergo surgery because of peri- and/or intra-articular fractures of the lower extremity.2,3 The standard aftercare treatment in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities features either non-weight bearing or partial weight bearing.4 According to the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Principles of Fracture Management, postoperative management of peri- and/or intra-articular fractures of the lower extremities consists of non-weight bearing for 6-12 weeks, followed by partial weight bearing with a 25% increase in fracture loading every week.5 Full weight bearing in this method will be reached generally 10-16 weeks post-surgery. Recent studies based on protocols using the existing non-weight bearing guidelines have reported composite postoperative complication rates of up to 37% with an average of 10-20% in patients with lower extremity fractures.6-15 The complications in trauma patients with peri- and/or intra-articular fractures of the lower extremities have a significant impact on the period of postoperative rehabilitation, suggesting substantial direct health-care costs and economic burden to the society. However, to our knowledge, no study has yet been done regarding the cost-of-illness (CoI) in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities. Insight into the estimation of the economic burden could help to raise awareness in policy makers about the disease and provide relevant information for economic evaluations in the future. The aim of this study was to determine the costs and QoL changes in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities over a 26 weeks period. The medical ethics committee of Maastricht University Medical Center, Maastricht, the Netherlands, approved this study, reference number: METC 16–4-236. Patient’s informed consent to participate was obtained from all patients. Patients and methods This prospective multicenter cohort study included surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities. Patients were recruited from 4 hospitals in the Netherlands (i.e Catharina Hospital, Eindhoven;

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