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POST TRAUMATIC OSTEOMYELITIS OF THE FEMUR OR TIBIA: AN EVALUATION OF THE CLINICAL OUTCOME, FUNCTIONAL OUTCOME,

AND QUALITY OF LIFE

BY

KHAIRUL RIZAL ZAYZAN

A dissertation submitted in partial fulfillment of the requirement for the degree of

Master of Orthopaedic Surgery

Kulliyyah of Medicine

International Islamic University Malaysia

DECEMBER 2015

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ABSTRACT

This study was conducted to evaluate the clinical outcome, functional outcome, and quality of life of patients treated for post traumatic osteomyelitis (PTO) of femur or tibia in Hospital Tengku Ampuan Afzan, Kuantan, Malaysia. A total of 119 patients were identified from the operating records from June 2007 until June 2014. 47 patients consented and participated in this study. The median age of participants was 44 years old, and ranges from 16 to 80 years old. There were 26 tibia and 21 femur osteomyelitis evaluated in this study. 38 participants (80.9%) had implants inserted and 9 participants (19.1%) had no implants. The participants were follow up .for a mean duration of 4.4 years (range 1.7-9.5 years). Interviews were then conducted and clinical assessment were performed to evaluate the clinical outcome. Their functional outcome were evaluated using the Lower Extremity Functional Score (LEFS) and the quality of life were evaluated using the SF-36v2 (validated and translated into Malay Language). As for the results, 93.6% of participants had a successful treatment and achieved union without recurrence of infection. 3 (6.4%) participants had failure of treatment were from CM-IIIA, CM-IVA, and CM-IVB. Staphylococcus aureus and MRSA were the 2 commonest microorganisms isolated from the culture. The mean scores of SF-36v2 of participants with PTO were significantly lower compared to the Malaysian general population. However with increasing age, the general health and vitality were similar with the Malaysian general population. Concurrent medical problem and CM- B(Systemic) hosts significantly contributed to poorer functional outcome, and lower quality of life score especially the Physical Component domain. In conclusion, most patients with post traumatic osteomyelitis had successful treatment. However their quality of life were poorer in comparison to the Malaysian general population.

Concurrent medical problem and CM-B(Systemic) hosts had significantly poorer functional outcome and quality of life than healthy patients. The key words in this research are post traumatic osteomyelitis, clinical outcome, functional outcome, and quality of life.

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APPROVAL PAGE

I certify that I have supervised and read this study and that in my opinion, it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Master of Orthopaedic Surgery

……….

Nazri Mohd Yusof Supervisor

This dissertation was submitted to the Department of Orthopaedic and is accepted as a partial fulfillment of the requirements for the degree of Master of Orthopaedic Surgery

………...

Mohamed Azril Mohamed Amin

Head, Department of Orthopaedic

This dissertation was submitted to the Kulliyyah of Medicine and is accepted as a partial fulfillment of the requirements for the degree of Master of Orthopaedic Surgery

………

Azmi Md Nor

Dean, Kulliyyah of Medicine

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DECLARATION

I hereby declare that this thesis is the result of my own investigation, except where otherwise stated. I also declare that it has not been previously or concurrently submitted as a whole for any other degrees at IIUM or other institutions.

Khairul Rizal Zayzan

Signature………. Date …...

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INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

DECLARATION OF COPYRIGHT AND AFFIRMATION OF FAIR USE OF UNPUBLISHED RESEARCH

POST TRAUMATIC OSTEOMYELITIS OF THE FEMUR OR TIBIA: AN EVALUATION OF THE CLINICAL OUTCOME,

FUNCTIONAL OUTCOME, AND QUALITY OF LIFE

I declare that the copyright holder of this dissertation are jointly owned by the student and IIUM.

Copyright ©2015 Khairul Rizal Zayzan and International Islamic University Malaysia. All rights reserved.

No part of this unpublished research may be reproduced, stored in a retrieval system, or transmitted, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without prior written permission of the copyright holder except as provided below.

1. Any material contained in or derived from this unpublished research may be used by others in their writing with due acknowledgement.

2. IIUM or its library will have the right to make and transmit copies (print or electronic) for institutional and academic purposes.

3. The IIUM library will have the right to make, store in a retrieval system and supply copies of this unpublished research if requested by other universities and research libraries.

By signing this form, I acknowledged that I have read and understand the IIUM Intellectual Property Right and Commercialization policy.

Affirmed by Khairul Rizal Zayzan

……..……..……… ………..

Signature Date

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ACKNOWLEDGEMENTS

In the name of Allah, the Most Gracious, the Most Merciful. Here, I would like to extend my highest gratitude to my supervisor, Associate Professor Dr Nazri Mohd Yusof for his patience, guidance, and continuous support though out this study. A million thanks to all my senior orthopaedic lecturers of International Islamic University of Malaysia (IIUM), Professor Dr Ahmad Hafiz, Associate Professor Kamarul Ariffin Khalid, Associate Professor Zamzuri Zakaria, Assistant Professor Mohd Azril Mohd Amin, Associate Professor Aminuddin Che Ahmad, and Associate Professor Mohd Shukrimi Awang.

My utmost appreciation for the undivided love and support from my parents, Zayzan Mohd Kader Baba and Latifah Ismail, my brother Khairul Razmi Zayzan, my lovely wife Dr Rafidah Mohd Rafie, and my two wonderful children, Khairyn Raisah and Muhammad Al-Fateh.

Special thanks to Professor Jamalludin Ab Rahman from the Department of Community Medicine IIUM for his humble help and guidance on the statistical analysis in this research. My humble thanks to all participants of this research, and to my fellow colleagues in the Master programme for their kind encouragement.

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TABLE OF CONTENTS

Abstract ... ii

Approval page ... iii

Declaration ... iv

Copyright Page ... v

Acknowledgements ... vi

List of Tables ... x

List of Figures ... xii

CHAPTER ONE: INTRODUCTION ... 1

1.1 Objectives and hypothesis ... 2

1.1.1 General objective ... 2

1.1.2 Specific objective ... 2

1.1.3 Hypothesis ... 2

CHAPTER TWO: LITERATURE REVIEW ... 3

2.1 Osteomyelitis ... 3

2.2 Microbiology ... 3

2.3 Rate of infection ... 4

2.4 Cierny-Mader Classification ... 5

2.5 Symptoms of chronic osteomyelitis ... 6

2.6 Investigations ... 7

2.7 Imaging modalities………...8

2.8 Treatment………...9

2.9 Antibiotics………...10

2.10 Surgical management………11

2.11 Outcome……….……...13

2.12 Clinical outcome………14

2.13 Quality of life evaluation with Short Form 36 (SF-36v2)……….15

2.14 Functional outcome evaluation with Lower Extremity Functional score(LEFS)……….……….16

CHAPTER THREE: RESEARCH METHODOLOGY ... 17

3.1 Research methodology ... 17

3.1.1 Inclusion criteria... 18

3.1.2 Exclusion criteria ... 18

3.2 Study design ... 22

CHAPTER FOUR: RESULTS AND FINDINGS ... 23

4.1 Descriptive statistics: Socio-demographic analysis, biomedical characteristics and fracture profile of participants ... 23

4.2 Descriptive statistics: SF-36v2 scores according to age group ... 29

4.3 Comparison between mean SF-36v2 scorrs of post traumatic osteomyelitis (PTO) with Malaysian general population (MGP) according to age group ... 32 4.3.1 Comparison between mean SF-36v2 scores of PTO (all ages)

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with MGP ... 33 4.3.2 Comparison between mean SF-36v2 scores of PTO (ages 16-29)

with MGP ... 35 4.3.3 Comparison between mean SF-36v2 scores of PTO (ages 16-29)

with MGP ... 36 4.3.4 Comparison between mean SF-36v2 scores of PTO (age 40-49)

with MGP ... 38 4.3.5 Comparison between mean SF-36v2 scores of PTO (age 50-59)

with MGP………... ... 39 4.3.6 Comparison between mean SF-36v2 scores of PTO (age 60-69)

with MGP ... ……….40 4.3.7 Comparison between mean SF-36v2 scores of PTO (age 70 &

over) with MGP ... ………41 4.4 Association between socio-demography with functional outcome

(LEFS) and quality of life (SF-36v2) ... 43 4.4.1 Association between age with functional outcome (LEFS) and

quality of life (SF-36v2) ... 43 4.4.2 Association between gender with functional outcome (LEFS) and

quality of life (SF-36v2) ... 44 4.4.3 Association between occupation with functional outcome (LEFS)

and quality of life (SF-36v2)………..45 4.5 Association between biomedical characteristics with functional outcome

(LEFS) and quality of life (SF-36v2) ... 46 4.5.1 Association between medical problem with functional outcome

(LEFS) and quality of life (SF-36v2) ... 46 4.5.2 Association between smoking with functional outcome (LEFS)

and quality of life (SF-36v2)………..47 4.6 Association between fracture profile with functional outcome (LEFS)

and quality of life (SF-36v2) ... 48 4.6.1 Association between type of fracture with functional outcome

(LEFS) and quality of life (SF-6v2)………...48 4.6.2 Association between presence of implant with functional

outcome (LEFS) and quality of life (SF-36v2)………...49 4.6.3 Association between site of osteomyelitis with functional

outcome (LEFS) and quality of life (SF-36v2)………...50 4.6.4 Association between Cierny-Mader (CM) physiological

classification (Host) with functional outcome (LEFS) and quality of life (SF-36v2)……….51 4.6.5 Association between Cierny-Mader (CM) anatomical

classification with functional outcome (LEFS) and quality of life (SF-36v2)………52 4.7 Association between functional outcome (LEFS) and quality of life

(SF-36v2) with age-adjusted Cierny-Mader classificcations ... 53 4.7.1 Association between functional outcome (LEFS) and CM

physiological classification (Host) with age………...53 4.7.2 Association between functional outcome (LEFS) and CM

anatomical classification with age………..53 4.7.3 Association between quality of life (SF-36v2) and CM

physiological classification with age………..54

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4.7.4 Association between quality of Life (SF-36v2) and CM)

anatomical classification with age………..55

4.8 Summary of results………...57

CHAPTER 5: DISCUSSION AND CONCLUSION ... 58

REFERENCES ... 64

APPENDIX A: CONSENT………...67

APPENDIX B: LOWER EXTREMITY FUNCTIONAL SCORE (LEFS)…………..72

APPENDIX C: SHORT FORM 36 VERSION 2 (SF-36V2)………...74

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LIST OF TABLES

Table No. Page No.

4.1 Description of socio-demography, biomedical characteristics and fracture profile of participants

26 4.2 Descriptive table of participants with failure of treatment 27 4.3 Descriptive table of SF-36v2 scores according to age groups 29 4.4 Comparison between mean SF-36v2 scores of PTO (all ages)

with MGP

34 4.5 Comparison between mean SF-36v2 scores of PTO (ages 16-

29) with MGP

35 4.6 Comparison between mean SF-36v2 scores of PTO (age 30-

39) with MGP

37 4.7 Comparison between mean SF-36v2 scores of PTO (age 40-

49) with MGP

38 4.8 Comparison between mean SF-36v2 scores of PTO (age 50-

59) with MGP

40 4.9 Comparison between mean SF-36v2 scores of PTO (age 60-

69) with MGP

41 4.10 Comparison between mean SF-36v2 scores of PTO (ages 70

& over) with MGP

42 4.11 Association between age with functional outcome (LEFS) and

quality of life (SF-36v2)

43 4.12 Association between gender with functional outcome (LEFS)

and quality of life (SF-36v2)

44 4.13 Association between occupation with functional outcome

(LEFS) and quality of life (SF-36v2)

45

4.14 Association between medical problem with functional outcome (LEFS) and quality of life (SF-36v2)

46

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Table No. Page No.

4.15 Association between smoking with functional outcome (LEFS) and quality of life (SF-36v2)

47 4.16 Association between type of fracture with functional outcome

(LEFS) and quality of life (SF-36v2)

48 4.17 Association between presence of implant with functional

outcome (LEFS) and quality of life (SF-36v2)

49 4.18 Association between site of osteomyelitis with functional

outcome (LEFS) and quality of life (SF-36v2)

50 4.19 Association between CM physiological classification (Host)

with functional outcome (LEFS) and quality of life (SF-36v2)

51 4.20 Association between CM anatomical classification with

functional outcome (LEFS) and quality of life (SF-36v2)

52 4.21 Association between functional outcome (LEFS) and CM

physiological (Host) classification with age

53 4.22 Association between functional outcome (LEFS) and CM

anatomical classification with age

53 4.23 Association between quality of life (SF-26v2) and CM

physiological classification with age

54 4.24 Association between quality of life (SF-36v2) and CM

physiological classification with age

55

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LIST OF FIGURES

Figure No. Page No.

2.1 Cierny-Mader classification of osteomyelitis 6

3.1 Study design 22

4.1 Description on the onset of infection of all participants prior to treatment

27 4.2 Description on the microbiology result based on culture and

sensitivity of all participants

28 4.3 Comparison between mean SF-36v2 scores of PTO and

MGP according to age group

32

4.4 Comparison between mean SF-36v2 scores of PTO (all ages) with MGP

33 4.5 Comparison between mean SF-36v2 scores of PTO (ages 16-

29) with MGP

35 4.6 Comparison between mean SF-36v2 scores of PTO (age 30-

39) with MGP

36 4.7 Comparison between mean SF-36v2 scores of PTO (age 40-

49) with MGP

38 4.8 Comparison between mean SF-36v2 scores of PTO (age 50-

59) with MGP

39 4.9 Comparison between mean SF-36v2 scores of PTO (age 60-

69) with MGP

40 4.10 Comparison between mean SF-36v2 scores of PTO (ages 70

& over) with MGP

41

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CHAPTER ONE INTRODUCTION

The rise in high velocity injury and internal fixation of fractures have increased the incidence of post traumatic osteomyelitis (PTO). The treatment is difficult, prolong and expensive. Failure rate is as high as 10% to about 30% of these cases (Tulner, 2004;

Campbell, 2011). Patients with impaired local and systemic immune response have risk about 50% recurrence (Simpson, 2001). Extent of resections will determine the outcome of treatment. Sanders et al (2015) quoted that there is 100% cure rate with wide excision, and 100% recurrence rate with intralesional biopsy and local debulking. Tibia PTO has poorer prognosis and is more difficult to treat (Beals, 2005). Beals et al (2005) also suggested that smoking influenced a poorer prognosis in their research sample.

The principle of management of posttraumatic chronic osteomyelitis revolves around surgical debridement, adequate and specific antibiotics to its causative microorganism, good dead space management, and finally the definitive reconstruction until cure is achieved (Lazzarini, 2004; Patzakis, 2005; Campbell, 2011; Sanders, 2013). There are many literatures that dwell on the methods of treatment and the clinical outcome of PTO. However, less work has been done on the functional outcome and quality of life for these patients. According to Egol et al (2009), with the improvement of treatment methods and increasing number successful result, the current trend of research is moving towards a more objective and holistic outcome measures.

Thus in this research we shall explore and objectively state the clinical outcome, functional outcome, and the quality of life of patients that have been treated for PTO in Hospital Tengku Ampuan Afzan, Kuantan.

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2 1.1 OBJECTIVES AND HYPOTHESIS 1.1.1 General objective

The purpose of this study is to investigate the clinical outcome, functional outcome and quality of life of patients treated for post traumatic osteomyelitis (PTO).

1.1.2 Specific objectives

1. To determine the association between the patients’ socio-demography and the clinical outcome, functional outcome, and their quality of life.

2. To determine the association between smoking and the clinical outcome, functional outcome, and their quality of life.

3. To determine the association between types of fracture and the clinical outcome, functional outcome, and their quality of life.

4. To determine the association between the site of osteomyelitis and the clinical outcome, functional outcome, and their quality of life.

5. To determine the association between the presence of implant and the clinical outcome, functional outcome, and their quality of life.

6. To determine the association between post traumatic osteomyelitis and the clinical outcome, functional outcome, and their quality of life.

1.1.3 Hypothesis

There is no difference in the functional outcome and quality of life of patients treated for PTO compared to the general population.

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CHAPTER TWO LITERATURE REVIEW

2.1 OSTEOMYELITIS

Osteomyelitis is an inflammation of bone and bone marrow, caused by a bacterial infection that can ultimately lead to bone necrosis (Gross, 2002; Lazzarini, 2004;

Patzakis, 2005; Egol, 2009; Calhoun, 2009; Hatzenbuehker, 2011). Osteomyelitis can be characterized as either acute (within 2 weeks of onset), sub-acute (within a few months), and chronic (years) (Egol, 2009). The infection occurs via two common mechanisms. Primary infections of the bloodstream may lead to osteomyelitis, and spread from an adjacent infectious focus (Lazzarini, 2004; Calhoun, 2009). However the common causes of posttraumatic osteomyelitis are the presence of necrotic bone, scar infection, poor dead space management, inadequate skin coverage, and chronic granulation tissue that developed in the medullary canal (Campbell, 2011).

2.2 MICROBIOLOGY

In the bone infection, a single pathogen is Staphylococcus aureus commonly isolated (Hierholzer, 1974; Nazri, 2004; Lazzarini, 2004; Patzakis, 2005; Campbell, 2011;

Sander, 2013). Pseudomonas aeruginosa is the second most common infecting organism and is found in about 20% to 37% of patients (Nazri, 2004; Patzakis, 2005;

Kinik, 2007). Besides, the infection may occur by direct bacterial inoculation into the bone during trauma, is commonly polymicrobial (Gross, 2002; Cierny, 2003; Kinik, 2007; Egol, 2009; Hatzenbuehler, 2011; Campbell, 2011; Sanders, 2013). The

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microorganism responsible may be cultured either by pre-operative biopsies, or a tissue sampled during the surgical debridement (Cierny, 2003).

Bone provides a unique harbor for microorganisms that produce biofilms. The biofilm, an exopolysaccharide polymer forms a protective fibrous matrix around microorganisms allowing them to attach resiliently to biologic and implanted surfaces while remaining insusceptible to host defences (Tice, 2003; Lazzarini, 2004; Costerton, 2005; Patzakis, 2005; Trampuz, 2006; Calhoun, 2009; Sanders, 2013). Approximately 59% of orthopaedic implant related infections had findings of glycocalyx-enclosed microorganisms on electron microscopy (Patzakis, 2005). This biofilm also protects the microorganisms from antibiotics and host immune phagocytosis thus infections tend to exist in a subclinical state and recur (Patzakis, 2005; Costerton, 2005). According to Costerton et al (2005), microorganisms within biofilms are resistant to antibiotic level 1000 times higher than those that will kill their planktonic microorganisms. Following the onset of infection, blood supply to the bone is compromised and consequently forms sequestrum (Patzakis, 2005; Sanders, 2013). The sequestrum provides an environment for bacterial biofilm formation, around them resulting in chronicity and persistence of infection (Costerton, 2005; Patzakis, 2005). Infection then propagades and new bone later formed around the focus of infection, known as the involucrum (Patzakis, 2005;

Sanders, 2013).

2.3 RATE OF INFECTION

Spread of infection in adult long bones may also result from placement of prosthesis in a closed fracture, open fracture, or introduction of foreign body (Patzakis, 2005;

Sanders, 2013). In a few studies, the infection rates of open long bones fracture ranges from 4%-64% and recurrence is as high as 20%-30% (Gross, 2002; Campbell, 2011;

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Hatzenbuehker, 2011; Sanders, 2013). The tibia is the commonest site of chronic posttraumatic osteomyelitis with the infection rate of 10% following open fracture (Patzakis, 2005; Campbell, 2011).

2.4 CIERNY-MADER CLASSIFICATION

The Cierny-Mader classification system for osteomyelitis describes four different types of osteomyelitis, Type I to Type IV, and the host’s immune status, Type A to Type C (Gross, 2002; Cierny, 2003). The classification mainly based on location and severity of the infectious focus. Type I is medullary osteomyelitis, Type II is superficial osteomyelitis, Type III is well marginated cortical bone, and Type IV, diffused destructive lesion (Cierny, 2003; Kinik, 2007). In medullary osteomyelitis the primary lesion is endosteal and the cause of the disease is commonly due to a nidus. Therefore in this case, the nidus is either an ischemic scar, chronic granulations, or a splinter sequestrum within the medullary canal (Cierny, 2003). In superficial osteomyelitis, the focus of infection is present over the bone surface, likely due to a compromised soft tissue envelope (Cierny, 2003). The findings of a localised osteomyelitis will be a cortical sequestration, or a cavitation, within a stable bony segment (Cierny, 2003). A localised osteomyelitis commonly due to trauma, however it may result as a combined features of medullary and superficial osteomyelitis (Cierny, 2003). As for a diffuse osteomyelitis, it is a circumferential infection of the hard and soft tissue, and following surgical debridement, skeletal stabilization is of paramount importance (Cierny, 2003).

The latter classification differentiates patients with healthy patient without comorbidities (Type A), 1 or more comorbidities that increase their risk of treatment failure (Type B), and immune compromised that the benefits of treatment are

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outweighed by the risks (Type C) (Cierny, 2003; Lazzarini, 2004; Patzakis, 2005; Egol, 2009; Calhoun, 2009; Juutilainen, 2011; Sanders, 2013).

Figure 2.1 Cierny-Mader classification of osteomyelitis

2.5 SYMPTOMS OF CHRONIC OSTEOMYELITIS

Symptoms of chronic osteomyelitis are sometimes occult and may include low-grade fever and chronic pain. Overlying skin changes, swelling, and sinus tracts over the site may be present (Gross, 2002; Lazzarini, 2004; Patzakis, 2005; Calhoun, 2009;

Hatzenbuehler, 2011; Sanders, 2013). Approximately in 0.2% to 1.6% of patients, chronic draining sinuses are complicated by metaplastic changes of the epithelial lining of the sinus tract, causing malignant transformation into a squamous cell carcinoma

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(also known as a Marjolin’s ulcer) (Patzakis, 2005). Moreover, the involved limb function is disturbed and also causes painful weight bearing (Gross, 2002).

2.6 INVESTIGATIONS

The erythrocyte sedimentation rate (ESR) and the C-reactive protein (CRP) level are markers of an inflammatory process, whether infectious or non-infectious (Lazzarini, 2004; Patzakis, 2005; Calhoun, 2009). Patzakis et al (2005) and Sanders et al (2013) explained that both the erythrocyte sedimentation rate (ESR) and the C-reactive protein (CRP) level were elevated in 64% of patients with chronic osteomyelitis. In another case, a persistently normal erythrocyte sedimentation rate and C-reactive protein level will rule out osteomyelitis (Hatzenbuehler, 2011). These biomarkers will eventually decrease following successful treatment, and their values should be reviewed pre- operative and post-operatively (Patzakis, 2005; Sanders, 2013). The white blood cell (WBC) count is usually normal in most patient with chronic osteomyelitis or infected non-union (Gross, 2002; Patzakis, 2005; Sanders, 2013). Other laboratory investigations including albumin, prealbumin, creatinine, and blood glucose should be monitored to ensure optimization of host factors (Sanders, 2013).

The diagnosis of osteomyelitis is confirmed after intraoperative biopsy that showed histopathological evidence of pyogenic osteomyelitis and evaluated for sensitivities (Egol, 2009; Patzakis, 2005; Sanders, 2013). However, cultures taken from sinus tract drainage are not reliable to determine the microorganism responsible for deep infection (Sanders, 2013).

According to Costerton et al (2005), all prosthetic loosening should be treated as being potentially infected due to unreliable culture results to diagnose orthopaedic implant related infections. Therefore, molecular methods like polymerase chain

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reaction (PCR) and fluorescence in situ hybridisation (FISH) are more suitable to detect infections with biofilms. Similar molecular test like enzyme-linked immunosorbent assay (ELISA) can also be advocated for the detection of biofilm in patients with orthopaedic prosthetic loosening.

2.7 IMAGING MODALITIES

In acute infection, the classic signs on plain radiographs include periosteal reaction and osteopenia. As the infection progresses, radiographic signs are soft tissue swelling, solid periostitis, lucencies, sequestration, periosteal and endosteal new bone formation, cloaca, and cortical irregularities. (Gross, 2002; Lazzarini, 2004; Patzakis, 2005;

Calhoun, 2009; Hatzenbuehker, 2011; Sanders, 2013). However in the presence of previous trauma, osseous anatomy is distorted, making the radiographic interpretation rather very challenging (Gross, 2002; Patzakis, 2005).

Computer tomography scan is best used for surgical planning because it demonstrates cortical bone details, by clearly identifies sequestrum, devascularised bone, and intraosseous fistulas (Gross, 2002; Lazzarini, 2004; Patzakis, 2005; Calhoun, 2009; Hatzenbuehker, 2011; Sanders, 2013).

Magnetic resonance imaging has high sensitivity and specificity for diagnosing osteomyelitis, which shows a decreased marrow signal on T1 weighted image and an increased marrow signal on T2 weighted image, due to edema or hyperemia (Gross, 2002; Lazzarini, 2004; Patzakis, 2005; Calhoun, 2009; Hatzenbuehker, 2011; Sanders, 2013). According to Patzakis et al (2005), the magnetic resonance imaging has a 98%

sensitivity and 75% specificity to detect osteomyelitis.

Technetium (Tc-99m) methylene diphosphonate bone scintigraphy has a high sensitivity for diagnosing osteomyelitis, but it has low specificity about only 18%,

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especially following trauma. Other technique like indium In-111-labeled white blood cell scanning has a sensitivity of 83% and a specificity of 86% to diagnose osteomyelitis (Gross, 2002; Patzakis, 2005).

In a meta-analysis by Termaat et al (2005), it showed that fluoro-deoxyglucose positron emission tomography is the most sensitive technique to detect chronic osteomyelitis, and it has a greater specificity than leukocyte scintigraphy, bone scintigraphy, or magnetic resonance imaging.

2.8 TREATMENT

Chronic infections are expensive and challenging to treat (Simpson, 2011). Post traumatic osteomyelitis of the tibia carries a failure rate up to 30% following treatment (Campbell, 2011). Definitive management of long bone osteomyelitis requires a multidisciplinary approach involving microbial-specific antibiotic administration, surgical debridement and reconstruction to stabilise the fracture, followed by restoration of bony defects (Hierholzer, 1974; Lazzarini, 2004; Patzakis, 2005; Campbell, 2011;

Sanders, 2013). The surgical method by local excision of osteomyelitis usually fails, and the infected bone has the potential to spread. Thus wide excision with clear margins is the most valid treatment principle (Sanders, 2013).

The author said that the treatment of long bone osteomyelitis should be treated aggressively as treating a malignancy, with wide clear margins. It is suggested to perform a wide excision as the cure rate is 100%, and the recurrence rate of infection is 100% with intralesional biopsy and debulking surgery (Sanders, 2013). Healthy bleeding tissue or Paprika sign must be visualized at all surgical boundaries to ensure adequate debridement (Simpson, 2011; Patzakis, 2005; Sanders, 2013).

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Moreover, after surgical debridement, the patient must be able to combat infection, resist contamination, heal surgical wounds, and tolerate the metabolic stress of multiple surgeries (Cierny, 2003). Local factors may lead to avascular compromise of bone and the surrounding soft tissue while systemic problem like smoking, or arterial disease affect immune defense and leucocyte function, and impair metabolism (Cierny, 2003; Patzakis, 2005). According to Gross et al (2002), host defense mechanisms are able to eliminate colonization of pathogens in osteomyelitis unless the inoculum size exceeds the immune system capacity for eradication, impaired general immune status, extensive soft tissue damage that impairs blood supply to infection focus, and unstable fracture fixation (Gross, 2002).

2.9 ANTIBIOTICS

According to Heirholzer et al (1974), fusidic acid is used as adjunct to operative intervention due to its high concentration in cancellous bone. Local concentration of fusidic acid after oral treatment in chronic osteomyelitis are found to be sufficient to inhibit staphylococcus growth, and a combination of fucidic acid with penicillin, methicillin, novobiocin, or tetracyclin will kill any fucidin-resistant mutants (Heirholzer, 1974).

The first line option of antibiotic is a beta-lactam unless methicillin-resistant Staphylococcus aureus (MRSA) is suspected. Intravenous vancomycin is therefore the

first-line antibiotic of choice (Hatzenbuehler, 2011).

The duration of antibiotic therapy is suggested from 4 to 6 weeks based on the knowledge that bone requires approximately 4 weeks to revascularise following surgical debridement (Cierny, 2003; Lazzarini, 2005; Patzakis, 2005; Sanders, 2013).

Antibiotic therapy alone usually fails due to poor vascular supply around diseased bone.

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Sanders et al (2013) also highlighted that there is no significant difference between recurrence rates 12 months after oral and parenteral antibiotic treatment. Other recent oral antibiotics like fluoroquinolones and clindamycin also showed evidence that oral antibiotic therapy can be as effective as parenteral treatments (Lazzarini, 2005). The advent of oral treatment is advantageous as it reduces duration of hospital stay and health care costs (Lazzarini, 2005).

According to Nazri et al (2012), intravenous antibiotic is given for two weeks and continue with oral antibiotic for another four weeks according to the culture and sensitivity result.

Local antibiotics can also be delivered by antibiotic-impregnated cement beads, which able to provide high local antibiotic concentrations and dead space management.

However, it has not been proven to be superior to intravenous antibiotics and require surgical removal. Biodegradable local antibiotic delivery systems are also currently used in the treatment of osteomyelitis (Sanders, 2013).

2.10 SURGICAL MANAGEMENT

Surgical debridement is highly critical and similar to a musculoskeletal tumour surgery, pre-operative planning is of paramount importance (Siegel, 1999; Simpson, 2001;

Kinik, 2007). Debridement must be done in a careful manner and incisions are made between myocutaneous territories (Cierny, 2003). Hardware is removed and debridement is performed in a centrifugal fashion until viable bone is seen, to keep the outer ring of bone attached to vascularised soft tissue (Cierny, 2003; Patzakis, 2005).

For medullary osteomyelitis (Stage I), debridement must excise the infected contents of the medullary canal, and deroofing of the cortex is usually necessary for curettage and reaming. For superficial osteomyelitis (Stage II), ischemic soft tissue is debrided and

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exposed bony surface decorticated until viable bone is visualised. Viable bone is identified when punctuate bleeding is seen, thus known as the paprika sign (Patzakis, 2005; Simpson, 2011). Sinus tract of more than a year must be debrided (Jain, 2005).

For localized osteomyelitis (Stage III), the debridement involves sequestrectomy, medullary decompression, scar and sinus excision, and superficial decortication (Cierny, 2003). At this stage, the reconstruction will depend on the size of the dead space. Stabilization is always necessary when the extent of the debridement increases the risk of fracture. As for the diffused osteomyelitis (Stage IV), external fixation is the safest and most versatile system after surgical debridement (Cierny, 2003). Staged procedures therefore involve the eradication of infection followed by bony reconstruction to achieve union and stability of the healthy bone. Reconstructive technique following large bony defect include the application of Ilizarov external device and Marsh et al reported a 100% cure rate at 1-year follow-up using this technique.

According to Patzakis et al (2005), inadequate debridement will cause recurrence of infection despite antibiotic therapy. Intraoperative samples of pus, soft tissue, and bone are sent for aerobic and anaerobic cultures. Cultures for mycobacterium and fungi are also sent for immunocompromised hosts with chronic osteomyelitis (Patzakis, 2005).

Surgical debridement commonly leaves a dead space in the bone and soft tissue.

Healing by secondary intention is not favourable as the scar tissue formation will eventually become avascular, infected, and causes persistent drainage (Cierny, 2003).

The aim of dead space management is to replace dead bone with vascularised tissue (Cierny, 2003). Bone grafts are preferably applied beneath a local or free muscle flap to manage the dead space. According to Patzakis et al (2005) and Gonzalez et al (2005), the gastrocnemius muscle flap are used for proximal third defects and the soleus muscle

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