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CHAPTER 1
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Spinal fractures: epidemiology, costs
In the Netherlands, from January 2004 until December 2006, 6099 patients were treated in a hospital for a thoracolumbar spinal fracture without neurological deficit. These numbers include spinal fractures due to trauma, as well as osteoporosis‐induced fractures and pathological fractures [125]. During the same period, 2947 patients in the age group of 20 to 60 years were treated for a traumatic thoracolumbar spinal fracture without neurological deficit. This means an incidence of traumatic thoracolumbar fractures (without neurological deficit) of approximately 1.2 per 10,000 per year in the Netherlands [125]. A study reporting about the incidence of spinal fractures in Canada shows an incidence of 64 per 100,000. These figures include all spinal fractures, including fractures induced by osteoporosis and cervical fractures [46]. In a study from England, the annual incidence of spinal fractures between the age of 20 to 60 years was 2.5 per 10,000 for men and 1 per 10,000 for women [124]. Neurological deficits, ranging from single root lesions to complete paraplegia, were found in 22% of the cases in a cohort of 1,212 thoracolumbar spinal fracture patients [77]. A recent study reported about a cohort of 1,251 spinal fracture patients, from which 18% displayed neurological deficits [59]. Total medical costs of injuries in the Netherlands in 1999 were EUR 1.15 billion or 3.7% of total health care costs. Spinal fractures (including spinal cord injury) rank 7th (3.8%) in total trauma costs, with a mean cost of EUR 6,600 per patient [87]. Total costs of spinal accidents were found to be approximately EUR 22 million in 1997 [112].
Classification
A classification should allow the identification of any injury by means of a simple algorithm based on easily recognizable and consistent radiographic and clinical characteristics. In addition, it should provide a concise and descriptive terminology, information regarding the severity of the injury and guidance as to the choice of treatment. Finally, it should serve as an useful tool for future studies [77]. Böhler was one of the first to classify spinal fractures in 1930 [9]. Subsequently, Watson‐Jones recognized that the concept of stability and ligamentous integrity would be crucial in spinal fracture management [142]. Nicoll, who published in 1949 about spinal fractures in miners, also emphasized the concept of stability [97].
GENERAL INTRODUCTION
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In 1963, Holdsworth presented a classification based on a two‐column theory [45]. The spine was visualized by 2 columns: the anterior column, consisting of the vertebral body and intervertebral disc, and the posterior column comprising the facet joints and the posterior ligamentous complex. After classification schemes by Kelly in 1968 [53] and Whitesides in 1977 [145], the first to present a three‐column theory was Louis in 1977 [75]. In the era of the computed tomography (CT), Denis presented in 1983 the nowadays frequently used three‐column theory [24]. The spine is divided into the anterior column (the anterior longitudinal ligament and the anterior two thirds of the vertebral body), the middle column (posterior one third of the vertebral body and the posterior longitudinal ligament) and the posterior column (all structures posterior to the posterior longitudinal ligament). In this system, spinal fractures are classified into four different types: compression fractures, burst fractures, seatbelt type injuries and fracture dislocations. Each of this type is then sub‐divided into one of three to four subtypes. According to Denis, loss of integrity in 2 out of the 3 columns will result in instability, consequently necessitating operative stabilization. Despite its widespread use, criticism on the Denis classification grew, stressing the oversimplification of the subject of instability. Attempts to modify the classification (emphasizing the presumed mechanistic properties of injury) were made by Ferguson and Allen [36]. McAfee extended Denis’ classification to further clarify stability in spinal fractures [81]. In 1994, two new classifications were presented; the load sharing classification (LSC) and the Comprehensive Classification (CC) [77, 82]. The LSC, developed by McCormack et al., rates the injury by giving points to 1) the amount of damaged vertebral body (comminution), 2) the spread of the fragments in the fracture site and 3) the amount of kyphosis correction necessary to restore the normal sagittal alignment [82]. This classification associates the vertebral body fracture‐anatomy with mechanical stability (the more points, the less load transfer capacity) and attempts to give direction to treatment. In addition to the Denis classification and the CC, the LSC is more and more used in literature [1, 102, 122]. Influenced by the increasing accessibility of CT and the need for a more sensitive classification, Magerl et al. presented the Comprehensive Classification in 1994, based on the AO fracture classification format [77]. It is based upon the patho‐morphological characteristics of the fracture, resulting in a progressive scale of growing morphological injury. The system distinguishes 3 main fracture types, following the suspected mechanism of injury:
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• type A fracture (compression of the vertebral body, no posterior lesions) • type B fracture (distraction, transverse disruption of 1 or 2 columns) • type C fracture (rotation, two‐column injury with rotational displacement)
Each of this fracture types is divided into three subgroups which are divided into a following subgroup, known from regular AO arrangement. In this classification, stability reduces by increasing classification, so a type C fracture is less stable than a type A fracture (see Table 1 and Figure 1). In this thesis, the Comprehensive Classification is used.
Table 1 Comprehensive Classification
A1.1 Endplate impaction
A1.2 Wedge impaction A1 Impaction fracture
A1.3 Vertebral body collapse
A2.1 Sagittal split fracture
A2.2 Coronal split fracture A2 Split fracture
A2.3 Pincer fracture
A3.1 Incomplete burst fracture
A3.2 Burst‐split fracture
A Compression injury
A3 Burst fracture
A3.3 Complete burst fracture
B1.1 With disc disruption B1 Posterior ligamentary lesion
B1.2 With type A fracture
B2.1 Transverse bicolumn
B2.2 With disc disruption B2 Posterior osseous lesion
B2.3 With type A fracture
B3.1 With subluxation
B3.2 With spondylolysis
B Distraction injury
B3 Anterior disc rupture
B3.3 With posterior dislocation C1.1 Rotational wedge fracture
C1.2 Rotational split fracture C1 Type A with rotation C1.3 Rotational burst fracture
C2.1 B1 lesion with rotation
C2.2 B2 lesion with rotation C2 Type B with rotation C2.3 B3 lesion with rotation
C3.1 Slice fracture
C Rotation injury
C3 Rotational shear injury C3.2 Oblique fracture
GENERAL INTRODUCTION
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A1 Impaction A2 Split A3 Burst
B1 Posterior B2 Osseous distraction B3 Posterior distraction ligamentous disruption injury with anterior disruption
C1 Rotation with C2 Rotation with C3 Rotation with A fracture B fracture shear
Fig. 1 Comprehensive Classification: Type A fractures (compression), type B fractures (distraction) and type C fractures (rotation)
At present, the Comprehensive Classification as well as the Denis classification are the most commonly used schemes in classifying spinal fractures [106]. However, some concerns are present when studying both schemes. Reliability and repeatability of both systems have shown to be moderate [7, 63, 147]. Furthermore, both systems lack an important issue: they do not completely consider the integrity of the posterior ligamentous complex (PLC). This complex is believed to be of great
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importance in maintaining spinal stability [19, 99, 100, 152]. Hence, disruption of this structure might result in spinal instability and may lead to severe pain if not managed properly [67]. Even so, a CT‐scan does not provide direct information on the soft tissues, so the role of the PLC is not entirely acknowledged in the (CT‐based) CC and Denis classification. Lesions to the PLC can only be assumed on CT‐scans when interspinous widening is present. Detecting PLC injury on plain X‐rays or CT‐scans has shown not be accurate. For example, Leferink et al. showed that 30% of type B fractures (PLC lesion present) are misdiagnosed and are classified as being type A fractures (PLC intact) when only plain X‐rays and CT‐scans are used [71]. Whereas the CT‐scan can not directly detect injuries to the PLC, images made by using Magnetic Resonance Imaging (MRI) can visualize damage to the soft tissues, including the PLC. Lee et al. demonstrated the accuracy of the MRI detecting PLC injury to be 97%, with a negative predictive value of 100% [66]. Recognizing the importance of the PLC (and intervertebral disc) in spinal stability, the use of MRI will most likely play an important role in new classification systems in the near future [100]. Recently, Vaccaro et al., acknowledging the role of the PLC, proposed a new classification and severity score, the ThoracoLumbar Injury Severity Score (TLISS) [134]. It is based upon 3 categories with points assigned to each specific variable in a category; 1) the mechanism of injury (1 to 4 points), 2) the integrity of the posterior ligamentous complex (0 to 3 points) and 3) the patient’s neurological status (0 to 3 points). Points are summed, 3 points or less would implicate non‐operative treatment, 5 points or more indicate operative treatment should be preferred. Four points is an intermediate score leading to management either way [134]. The system demonstrated good reliability in terms of intra‐observer and inter‐observer agreement [106]. Lately, its concept has been modified by placing more emphasis on the morphology, resulting in the ThoracoLumbar Injury Classification and Severity Score (TLICS) [67, 132]. In the future, this scheme might possibly replace the commonly used classification schemes.
Treatment
The treatment goal in spinal fractures is to obtain early patient mobilization and a painless, balanced, stable vertebral column with maximum spine mobility and optimal neurological function [32]. In the light of the ICF (see page 12) this would mean a patient with no loss of body function, who can undertake all activities in the context of his or her culture [150].
GENERAL INTRODUCTION
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Until the 1970’s non‐operative treatment was the paradigm in curing spinal fractures. Hippocrates was one of the first to treat spinal fractures [89]. Hippocrates, and later on Oribasius, treated patients by distraction, reduction and rest on a scamnum (see Figure 2). The word “scamnum” originates from Latin denoting “low bench” [89]. Since that time, many variations in non‐operative treatment have been used.
Fig. 2 Distraction and reduction on a scamnum
Non‐operative treatment can consist of bed rest, postural reduction, direct mobilization, ambulatory bracing (for example with a reclination brace, see Figure 3), and combinations of these. An early goal of non‐operative treatment is a mobile patient with or without brace. The means used as how to achieve this rather vary in literature and seem to be to some extent empirically based. Mumford et al. claimed good results after one month of bedrest followed by 3 months of bracing [94]. Shen advocated direct mobilization with or without a Jewett brace in three‐column “burst” fractures [120]. Closed reduction (on a Cotrel frame by axial traction and anterior shear) and casting for 3 months were described by Tropiano et al. [130]. Kinoshita et al. proposed 3 months of bedrest followed by a brace [54]. Others describe more or less equal treatment strategies, ranging from one week to 3 months of bedrest followed by a brace or thoracolumbosacral orthosis (TLSO) for 3 to 6 months [1, 14, 15, 38, 104, 107, 128]. Weinstein et al., as one of the most cited authors in this line of work, claimed good results after immediate mobilization with a brace or up to 3 months of bed rest [143].
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Fig. 3 Example of a three‐point reclination brace
With the development of operative techniques in the 1970’s, however, a second treatment modality for spinal fractures became available. Harrington instrumentation, which originally was developed for scoliosis surgery, was presented for use in spinal fractures in 1973 [28]. The Harrington system, using distraction and fixation, became the worldwide standard for operative stabilization in spinal fractures. Despite, some problems were encountered: a large part of the spine had to be immobilized (from 3 segments above the injured level to 3 segments below) to create a firm fixation. The Luque rod system, using sublaminar wires, achieved better fusion although more neurological complications occurred compared to the Harrington system [64]. Some of these problems were solved by the “Harrington‐like” Cotrel‐Dubousset instrumentation [92]. Meanwhile, Roy‐Camille et al. presented a technique consisting of posterior plates with screws positioned through the pedicles [117]. This transpedicular technique, combined with the “Harrington rod idea”, resulted (partially via Magerl’s fixateur externe) in the nowadays frequently used system according to Dick [26, 27, 78]. This technique consists of transpedicular placement of screws one level above and one level below the fractured vertebral body, which act as levers in reducing the kyphosis. These screws are connected by two short rods and so construct the “fixateur interne” according to Dick [27]. The most important advantage of this procedure is its capacity to create (and partly preserve) reduction of fractures by only immobilizing 2 segments.
GENERAL INTRODUCTION
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Nowadays, posterior transpedicular fixation devices are the standard in dorsal operative approaches. Many dorsal implants are available today, all referring to the Dick internal fixator (see Figure 4) [16, 65, 116]. In this thesis, all patients who were managed operatively were treated by internal fixation, using the Universal Spine System [65].
Fig. 4 Example of an internal fixator in a model, bridging one segment
The dorsal approach is not the only possible operative procedure, though. Dunn and Kaneda presented a ventral approach in 1984 [31, 52]. This new technique was developed because of concerns about the retropulsed bony fragments which became visible on CT‐scans. The consideration was that a direct, anterior approach would offer better decompression of the spinal cord than an indirect posterior approach mainly based on ligamentotaxis [136]. Kostuik put the anterior and posterior approach together and presented the anterior Kostuik‐Harrington distraction device [60]. Presently, multiple types of anterior devices are available [138]. The anterior approach allows decompression of anterior neural compression, reconstruction of the anterior and middle columns of the thoracolumbar spine, and osteotomy through the vertebral body if needed [111]. It can be used as the first and only step (for example in high thoracic fractures) or as a second procedure when dorsal instrumentation has failed to adequately decompress the spinal canal [138]. The spinal column can be approached through thoracotomy, video‐assisted thoracoscopic surgery, and open transabdominal and retroperitoneal exposure [47].
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Recently, vertebroplasty and balloon kyphoplasty have become a topic of interest in the treatment of traumatic spinal fractures [137]. In vertebroplasty and balloon kyphoplasty, an inflatable balloon is brought into the fractured vertebral body percutaneously. By inflating the balloon, it restores height and corrects the kyphotic deformity. Afterwards, cement is injected into the remaining cavity. It is a commonly used technique for treating osteoporotic impression fractures [72]. However, recently it has also been used in the treatment of traumatic spinal fractures [101, 135]. The technique was found to be safe, but clinical results are still uncertain. Nowadays spinal fractures, like most other fractures, can be treated operatively or non‐operatively. Both modalities have their own advantages and disadvantages. Benefits of the operative approach are the improvement of spinal alignment, decreased deformity, early mobilization and rehabilitation (with a decrease in the complications of long bed rest) and sometimes improvement in neurological function or decreasing the possibility of neurological deterioration [40, 119, 146]. On the other hand, non‐operative treatment lacks the risks of surgery, such as deep wound infection, iatrogenic neurological injury and implant failure [107, 120, 146]. Furthermore, non‐operative treatment seems to be less expensive [44, 112, 121].
Indications
The decision to treat either operatively or non‐operatively is based on clinical (age, co‐morbidity, neurological status, other major injuries) and radiological findings. The distinction between stability and instability of the spine and the patient’s neurological status play an important role. Instability can be defined as the loss of the ability of the spine under physiological loads to maintain relationships between vertebrae so that there is no initial or additional neurological deficit, no major deformity, and no incapacitating pain [144]. In general, patients with stable fractures without gross deformities and no neurological deficits are treated non‐operatively. Patients with gross deformity and progressive neurological deficits are treated operatively. On the other hand, these are only indistinct criteria. In clinical practice, the decision on how to treat a traumatic thoracolumbar spinal fracture seems to be less simple. This is especially true for the so‐called “burst” fracture, i.e. the type A3.1, A3.2 and A3.3 fracture according to the CC [77]. This type of fracture is characterized by comminution of the vertebral body with centrifugal extrusion of fragments, whereas the posterior ligamentous complex is intact. The hallmark of this type of fracture is the extrusion
GENERAL INTRODUCTION
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from bone into the spinal canal (disruption of the dorsal side of the vertebral body) (see Figure 5). The most favourable treatment for this fracture is still unknown; a large amount of literature is available concerning this “burst” fracture, reporting good results after both operative as well as non‐operative treatment [19, 22, 62, 107, 119, 122, 146].
Fig. 5 X‐ray (a) and CT‐scan (b) of a type A3.1 fracture (T12) in an 18‐year‐old male. Post‐operative status is shown in (c)
Nevertheless, when one has to decide which treatment is viable for a particular patient, which measure should one choose in determining success? Should the result of treatment be judged on radiological appearance of the vertebrae? Is the cost of treatment of any importance? Or should the result be measured in terms of patient satisfaction, pain or restrictions in daily activities? During the last decades, the concept of functional outcome has gained attention to evaluate the result of treatment [126].
Functional outcome
A precise definition of functional outcome is not easy to formulate. According to Baumberg et al., outcome is “the result of health care processes” [3]. However, this might not cover the complete meaning of functional outcome. Liebenson describes functional outcome as “the measurement of a patient’s status, either symptomatically or functionally” [74]. Outcome after trauma can be evaluated in numerous ways. One can measure survival, which is a simple, but in the field of spinal fractures less suitable approach. Usually, functional outcome is measured as a summary of numerous
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characteristics of daily living, like pain, return to work, ability to sport or social functioning. The International Classification of Impairments, Disabilities and Handicaps (ICIDH), published by the World Health Organization in 1980, is a model to describe the result of disease on patients’ health status [149]. In short, 4 entities are considered for any kind of disease (including trauma): pathology, impairment, disability and handicap. According to the World Health Organization, health can be defined as “a state of complete physical, mental and social well‐being and not merely the absence of disease or infirmity” [148]. In 2001, the “revised version” of the ICIDH was published, the International Classification of Functioning, Disability and Health (ICF) [150]. It consists of 3 more positively emphasized categories (body function/structure, activity, participation), all of these influenced by personal and environmental factors [150]. Significant deviations, or loss of body function and structure replace “impairment”. Activity is defined as performance of person‐level tasks or activities undertaken by a person in the context of their culture. Participation replaces “handicap” and expands the scope of disablement by classifying most areas of human life (see Figure 6) [127]. As being a more psychosocial model than the ICIDH, the ICF makes it possible to grade all the variables related to patients’ health status. Nevertheless, in reality it becomes clear that most outcome measures (including questionnaires) do not cover all the domains of the ICF [127].
Fig. 6 Health model according to the ICF
disorder / disease
environmental factors personal factors
body function & structure activity participation
GENERAL INTRODUCTION
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Whereas in the beginning functional outcome was traditionally the area of rehabilitation medicine, during the last decade also other domains of medicine have paid interest in functional outcome. This includes the field of traumatology as well [19, 119, 122, 146]. In spinal fracture research, Weinstein et al. in 1988 were one of the first to study functional outcome [143]. Later on others studied outcome in different types of spinal fractures and treatments using variable outcome measures [1, 15, 94]. Kraemer et al., in 1996, even referred to the “traditional” radiological results as “surrogate outcome” [62]. Why should one measure functional outcome? Functional outcome measurements make it possible to 1) quantify clinical signs and symptoms, 2) objectify clinical symptoms, 3) make a baseline assessment, 4) evaluate the clinical course, 5) possibly predict the clinical course for the future and 6) establish a reliable basis for decision making [21]. By means of measurement instruments (including questionnaires) the afore‐mentioned data can be assembled in a uniform manner. This raises the question which instruments are available for evaluating outcome in spinal fractures.
Functional outcome measures
Measurement instruments can be divided into anthropometrical instruments (for example an inclinometer), questionnaires (to be completed by patients) and observational lists (to be completed by the examiner). Furthermore, one can test physical performance. Finally, combinations of all these entities are possible. When using a measurement instrument it should be reliable, valid, and responsive to the clinical change that occurs over time. Reliability describes how uniformly a test can be repeated when utilized on more than one occasion or by more than one rater, i.e. the consistency. Reliability can be tested as inter‐rater reliability (i.e. the reliability between more than one rater) and intra‐rater reliability (i.e. the reliability for the same rater when measuring at different occasions). Validity is the extent to which the instrument measures what it intends to measure. Responsiveness is the capacity of the measure to identify changes in patients’ health status over time. For a measurement instrument to be useful in clinical practice, it should satisfy at least the first two criteria described, and when measuring at different moments in time the last condition should be fulfilled as well.
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To measure outcomes in patients who sustained a spinal fracture multiple instruments are available (classified according to the ICF):
Measurements of impairments in body function and structure: Neurological status The neurological status after a spinal fracture is a gross, though useful measure. The most frequently used classification is that of Frankel, which describes spinal cord injuries according to the severity of deficit below the level of injury [39]. • Group A: complete interruption of all sensation and motor function • Group B: incomplete interruption, with some sensation but no motor function • Group C: incomplete interruption, with demonstrable voluntary motor function
but at a minimal, non‐useful level • Group D: incomplete interruption, with some voluntary motor function that is
useful to the patient • Group E: normal functioning
Physical capacity Physical performance measures have the potential to complement clinicians’ assessments and patients’ reports of outcome. Some of the measures used are:
• Range of Motion The Range of Motion (ROM) is a frequently proposed outcome measure. Concerning its use as outcome measure, literature reveals conflicting results, reporting about no to poor relationship between ROM and disability as well as significant correlation [18, 88, 95, 103, 140].
• Muscle strength One can use isokinetic or non‐dynamometric tests for assessing their correlation with subjective low back pain symptoms. For example, leg raising or repetitive arch‐up and sit‐up tests can be performed. In literature, the latter correlated significantly with pain and disability [69, 74, 110]. The Sorensen test, which is a static back‐extensor test, was found to correlate with disability in low back pain patients [6].
• Endurance tests Functional capacity (quantifying a larger component of body functioning) can be tested with lifting or carrying tests. Functional capacity, focussing on aerobic (cardiopulmonary) ability can be assessed with the use of a cycle ergometer. Cor‐relation with disability varied in literature though [37, 73, 84, 123].
GENERAL INTRODUCTION
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The progressive isoinertial lifting evaluation (PILE), which we used in Chapter 4, is a psychophysical, isoinertial lifting test [79]. The patient is asked to repeatedly lift a weight from the floor to a table, this should be completed 4 times in 20 seconds. After each cycle, the load is increased [79]. Isoinertial relates to the force of a human muscle that is applied to a constant mass in motion. The psychophysical component lies in the fact that a patient can stop lifting when he finds himself at a point of discomfort or overexertion [79]. As such, this test represents a self‐selected “real world” lifting technique. The patient chooses the posture he experiences comfortable, and stops lifting when psychophysical (cognitive) factors like fatigue necessitate doing so. A weakness of the PILE (and all lifting tests) is the incapability to distinguish the “weak link” anywhere along the biomechanical chain.
Measurements of limitations in activity or participation: Return to work Return to work (RTW) is an outcome that is highly valued by patients, employers, insurance companies and society [1, 104, 119, 122, 143]. Clinicians frequently include return to work as one of the treatment goals. Although being a valuable outcome measure, RTW is affected by socio‐economic characteristics, economic incentives, job characteristics as well as employment status [43, 76, 109].
Health‐related quality of life Instruments measuring health‐related quality of life are mostly questionnaires. These questionnaires can be classified as generic (designed for broad use in a variety of patient populations) or condition‐specific (designed for use in specific patient populations). Condition‐specific instruments have several advantages. First, they target specific components of function that are most relevant to the disease or condition, furthermore they may be more responsive than generic instruments. In addition, many of these instruments can be scored quickly and the interpretation of their scores is less complex [109]. The following questionnaires have been used in spinal fracture patients:
Generic instruments • SF‐36 The Medical Outcomes Study 36‐item Short Form health survey (SF‐36) scale contains 9 scales measuring physical functioning, social functioning, role restriction due to physical problems, role restriction due to emotional problems,
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mental health, energy and vitality, pain, general perception of health and change in health over the past year. Scores can vary from 0 to 100, higher scores indicate better results [42, 141]. In literature, the test was found to be a reliable and valid measure [85].
• Sickness Impact Profile The Sickness Impact Profile (SIP) has been used in different (trauma) populations and is a reliable and valid instrument to measure the health‐related quality of life [5, 105]. The instrument is composed of 136 statements describing health‐related dysfunctional behaviors. The statements are grouped into 12 categories. A score can be computed for the overall instrument (SIP‐total) and for two subscales that characterize physical (SIP‐physical) and psychosocial dysfunction (SIP‐psychosocial). SIP scores from 0 to 3 are considered to reflect no disability, scores from 4 to 9 reveal mild disablement and scores from 10 to 19 illustrate moderate disability; severe disablement is reflected by SIP scores from 20 to 100 [51].
• EQ‐5D This questionnaire, formerly known as the EuroQol instrument, was published in 1990. The system consists of 5 domains: mobility, self‐care, usual activity, pain/discomfort and anxiety/depression. Each dimension has 3 levels, reflecting “no problem”, “some problem” and “extreme problem” [129]. Since 1998, a 6th dimension (cognition) has been added [61]. It has proved to be a valid and reliable instrument [17].
• Nottingham Health Profile (NHP) The NHP was originally developed to be used in epidemiological health studies. It assesses perceived or subjective health by asking for “yes” or “no” responses to 38 statements in 6 categories (energy level, emotional reactions, physical mobility, pain, social isolation and sleep). Scores, using weighted values, can range from 0 (no problems) to 100 (all items checked) for each category [83]. The NHP was found to be a valid and reliable measure [48].
Condition‐specific instruments More than 40 back pain questionnaires are available. The most frequently used are:
• Roland‐Morris Disability Questionnaire (RMDQ) The RMDQ is derived from the Sickness Impact Profile, from which 24 out of 136 items are selected. Those 24 questions are ticked dichotomously (yes/no). Each positive answer results in one point. The lowest possible score is 0 (no impairment) and the highest score is 24 (maximum impairment) [115]. The questions deal with
GENERAL INTRODUCTION
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body functions (pain, sleeping and appetite) as well as activities (self care, walking, sitting, standing, lifting, work, dressing, stairs, housework and resting), but no environmental questions are included [93]. The RMDQ is one of the most frequently used questionnaires in spinal fracture populations, and showed to be a sensitive, reliable and valid instrument [93, 109, 126]. The Dutch version of the RMDQ was used in this thesis. This Dutch version also proved to be a reliable and valid measure [12, 114].
• Oswestry Disability Index The Oswestry Disability Index (ODI) is a valid and reliable questionnaire designed for determining the degree of functional limitation in patients consulting with low back pain in secondary care [20]. Ten items covering pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling are scored [35]. However, important items considering the ability to work, need for help and items about environmental factors are not included. Nevertheless, together with the RMDQ it is the most frequently used questionnaire in low back pain and spinal fracture research [93].
• Denis outcome scale The Denis outcome scale recognizes 3 categories (pain, restriction in work and restriction in recreational activities), all on a scale of 1 to 5. One point is the most perfect situation, whereas 5 points indicate the worst possible outcome [25]. As a rather simple tool, it is popular in spinal fracture literature, although no studies concerning its psychometric characteristics are available.
• Visual Analogue Scale Spine Score The Visual Analogue Scale Spine Score (VAS) has the unique feature that it is developed to be used in spinal fracture patients. Patients are asked to rate the functional outcome in 19 items on a 10 cm visual scale. The patient’s perception of pain and restriction in activities related to back‐problems is measured. Higher scores represent better results, converted to percentages of the maximum score (0‐100). It has proved to be a reliable and valid instrument [58].
• Million Visual Analogue Scale This questionnaire was first published in 1982 for use in patients with chronic back pain. The 15 items focus on body functions (pain, sleep, stiffness and twisting), on activities (walking, sitting, standing and work) and on social life [90]. Answers are scored on a 10 cm visual analogue scale. According to the literature it is a valid and reliable instrument [93].
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• Waddell Disability Index (WDI) The WDI is a brief 9‐item scale focussing on disabilities (walking, sitting, standing, lifting, sex life, travelling and dressing), on body functions (pain, sleep) and on social life. Questions about work, self care and sports are not included [139]. Psychometric properties were reported to be good [20].
Literature review
Some data regarding functional outcome after a spinal fracture are available. Comparison of the results remains a difficult topic since treatment modalities, fracture classification, numbers of patients and outcome measures frequently vary between different authors. Some issues though seem to be generally accepted. There appears to be no correlation between the radiological appearance of the healed vertebral body (e.g. anterior wedge angle, vertebral height) and the functional outcome [38, 62, 94, 108, 122, 128, 143]. Furthermore, outcome in patients without neurological injury generally seems fairly good, both after operative as non‐operative treatment. Neurological deficit seems to have the greatest impact on outcome [86].
McLain studied outcome after spinal fractures treated with Cotrel‐Dubousset instrumentation [86]. Seventy percent of the subjects returned to full‐time work, 56% had no functional limitations. In a study concerning operative treatment after type A, B and C fractures (Comprehensive Classification) the RTW rate was found to be 50%, the mean Hannover spine score was 72% [56, 57]. In a meta analysis, 84% of the patients were found to have a P1 or P2 status (meaning no or minimal pain) after dorsal stabilization, 83% of the patients achieved W1 and W2 (indicating return to heavy labour or lighter labour) [25, 136]. A short time ago, Briem et al. measured outcome after operative and non‐operative treatment for type A and B fractures [10]. Results for the operative group showed a score of 72 points on the physical functioning index of the SF‐36 together with a VAS spine score of 60 points. In the non‐operatively treated group, these numbers were 75 and 67, respectively. Outcomes did not differ between these groups [10]. Reinhold et al. measured functional outcome 16 years after a non‐operatively treated type A fracture [108]. A mean VAS spine score of 58 points (indicating moderate impairment) was found. A study concerning outcome after non‐operatively treated wedge fractures (without neurological deficits) showed a score of 56 points (demonstrating rather severe impairment) on the Oswestry scale, 25%
GENERAL INTRODUCTION
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of patients had changed their job [38]. Tezer et al. studied outcome after non‐operative treatment for spinal compression and “burst” fractures [128]. Pain was measured by means of Denis’ scale; the mean pain score was 1.66 (compression fractures) and 1.26 in the “burst” fractures [128]. The so‐called “burst” fracture (the type A3 fracture according to the Comprehensive Classification [77]) remains a fierce topic of debate. It is a fracture type that shows different outcomes in different treatment modalities. Operative treatment in this type of fracture shows good results. Leferink et al. reported good results after dorsal instrumentation; the mean RMDQ score was 4 and a mean VAS spine score of 79 was found [69]. In another study a score of 69 points on the SF‐36 physical functioning scale was found 4 years after dorsal instrumentation [11]. Sanderson et al. found good to excellent outcomes in 62% of patients treated operatively [118]. Recently, Defino et al. reported 66% of patients displaying P1 or P2 (indicating no or occasional pain [25]) two years after operative treatment for a type A3 fracture [22]. Non‐operative treatment in this type of fracture demonstrates good outcome as well. Mumford et al. found good to excellent outcomes in 66% of patients and the RTW rate was 81% [94]. Reid et al. reported a satisfactory pain score in all patients [107], whereas Aligizakis et al. found satisfactory results in 91% of patients [1]. Also other studies showed good results after non‐operative treatment [14, 15, 130, 143]. Studies directly comparing operative and non‐operative treatment for the type A3 “burst” fracture reveal contradictory results. Denis et al. found in a retrospective study superior outcomes after operative treatment, with a neurological deterioration in 17% of patients treated non‐operatively versus no deterioration after operative treatment [25]. These high percentages of neurological worsening though seem extraordinary. Such considerably high numbers have never been reported in other papers. Butler et al. found better outcomes (as measured by Denis’ outcome scale) for those treated non‐operatively [13]. Shen et al. reported no significant differences in RTW, SF‐36 and Oswestry scores after operative and non‐operative treatment at a 2‐year follow‐up. Operative treatment resulted in earlier pain reduction than non‐operative treatment, yet costs of operative treatment doubled that of non‐operative treatment [119]. Also other authors could not demonstrate a difference in outcome between operative and non‐operative treatment for the type A3 fracture [30, 55, 62]. Studies afore‐mentioned were all carried out in a retrospective setting, however. Recently, a literature review concerning optimal treatment in the type A3 “burst” fracture has been presented
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by Dai et al. [19]. According to this review, no superior treatment exists in the neurological intact type A3 “burst” fracture. A recent Cochrane review found only one adequate prospective randomized controlled trial comparing operative and non‐operative treatment [146, 151]. This study, by Wood et al., found a significant higher RMDQ score of 8.2 for those patients treated operatively versus 3.9 for those treated non‐operatively. RTW rates did not differ between the groups, SF‐36 and Oswestry scores did not differ either. They concluded that non‐operative treatment in type A3 “burst” fractures is at least as valuable as operative treatment [146]. Short after this Cochrane publication, a paper by Siebenga et al. was published comparing treatment outcomes after type A3 fractures, studied in a multi‐centre, prospective randomized setting [122]. They found better outcomes in patients treated operatively. Above‐mentioned studies report nearly all on dorsal operative procedures. Data on functional outcome after ventral operative procedures are scarce. On one hand, anterior surgery could produce a more complete and reliable decompression of the spinal canal; on the other hand it requires a more sophisticated technique and may result in serious adverse effects [33]. Okuyama et al. found good results after anterior surgery, 84% of the patients scoring P1 or P2, indicating minimal or no pain [25, 98]. Ghanayem et al. found good or excellent results in 92% of patients after anterior instrumentation [41].
The aim of this thesis is to study different aspects of functional outcome after a spinal fracture. Considering the above described, much is known on this topic, but many questions remain unsolved. For example, what is the ROM after a spinal fracture, how does it correlate with functional outcome, and how to measure the ROM? Furthermore, what is the short‐term and long‐term outcome after non‐operatively treated type A fractures without neurological deficit? Also the optimal treatment (operative versus non‐operative) in the type A3 “burst” fracture remains unknown. Together with other specific questions this thesis tries to find an answer to these issues.
Outline of the thesis
Information on epidemiology, classification, treatment, functional outcome and its measures as well as a literature review on the topic of spinal fractures is provided in Chapter 1. In measuring functional outcome, one proposed tool is the assessment of ROM. Many methods of evaluating spinal range of motion have been described. One
GENERAL INTRODUCTION
21
method used is radiological analysis (CT‐scans, plain‐ and biplanar radiography) [29, 49, 91]. Radiological measurement, however, carries the risk of the relatively high dose of radiation it requires, which precludes its use as a routine measurement in clinical practice. Consequently, many non‐invasive, external methods have been developed like goniometers, skin markers, inclinometers and spondylometers [68, 80, 96]. Since they are relatively easy to use and involve little clinical time, external methods are nowadays commonly used [96]. The clinical usage and validation of the SpinalMouse, a computerized external device for measuring spinal ROM is presented in Chapter 2. Inter‐rater reliability and use in clinical practice were studied. The residual range of motion after a spinal fracture is uncertain. Literature with reference to total spinal mobility is scarce, as most studies report about intersegmental ROM [23, 70, 113]. The few studies available concerning total spinal ROM after a spinal fracture reveal contradictory results. In one study sagittal spinal ROM was found to be normal after operative treatment for thoracolumbar spinal fractures [50]. Another study reported that spinal ROM did not return to normal after Harrington rod removal in patients treated operatively for a spinal fracture [29]. As the ROM after a spinal fracture is still uncertain, little is known about the influence of the resulting spinal ROM on subjective impairment. In other words, is measurement of spinal ROM a valid measure for assessing functional outcome? Previously published papers concerning this issue show different results [18, 95, 103]. Spinal range of motion after a spinal fracture is illustrated in Chapter 3. We measured thoracolumbar ROM and functional outcome in operatively and non‐operatively treated spinal fracture patients as well as in controls. The following issues were addressed: • Is there a difference in sagittal spinal ROM between operatively treated
patients, non‐operatively treated patients and controls? • Do the average VAS and RMDQ scores differ between operatively treated
patients, non‐operatively treated patients and controls? • Does sagittal spinal ROM correlate with subjective impairment, measured by
the RMDQ and VAS?
In Chapter 4 the functional outcome after non‐operative treatment of type A spinal fractures without neurological deficit is presented. Functional outcome was determined in a wide spectrum following the International Classification of Functioning, Disability and Health (ICF), measuring restrictions in body function and structure, restrictions in activities, and restrictions in participation/quality of
CHAPTER 1
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life [131, 150]. Patients completed physical tests (dynamic lifting tests as well as an ergometry exercise test) plus questionnaires to construct a well‐based functional outcome dimension. Most of the published data on functional outcome after a spinal fracture concentrate on relatively short‐term results. Literature regarding long‐term outcome (10 years and over) is reasonably scarce [38, 108, 143]. It is known that pain may arise in the long term due to changed facet joint motion and hyperextension of adjacent spinal regions, leading to ongoing degenerative processes [99, 133]. Also fatigue pain from the soft tissues has been described as contributing to back pain in the long term [4, 130]. Chapter 5 describes the long‐term functional outcome of non‐operatively treated type A spinal fracture patients. Functional outcome approximately 10 years after trauma was measured by means of questionnaires. Long‐term outcome was compared to the mid‐term functional outcome (4 years post‐injury) in the same cohort of patients. In spite of much literature trying to find the optimal treatment (operative versus non‐operative) in the type A3 “burst” fracture still no clear answer is available regarding this topic [119, 122, 146]. Operative treatment provides the benefits of improvement in spinal alignment, decreased deformity, early mobilization and improvement in neurological functioning [2, 25, 34, 99]. Alternatively, non‐operative treatment does not carry the risks of surgery, like deep wound infection, iatrogenic neurological damage and implant failure [14, 94, 107, 120]. Some studies comparing short‐term functional outcomes are available, literature regarding long‐term outcome is less presented. Several authors fear complications in the long term though, like progressive kyphosis and pain [8, 133]. In Chapter 6 we compared long‐term (5 years) functional outcomes of operatively and non‐operatively treated patients who sustained a type A3 “burst” fracture without neurological deficit. A general discussion is provided in Chapter 7. The studies enclosed are reviewed and conclusions are drawn, some recommendations are made and future research options are discussed. Finally, a summary is presented in Chapter 8, followed by a summary in Dutch in Chapter 9.
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