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CASE REPORT

Osteoporotic Vertebral Fragility Fractures – Treatment and Management

Jonathan R Perera *,Abbas G Rashid** ,Panagiotis D Gikas*,Rajiv A Bajekal**,Sean Molloy*

 

*Department of Royal National Orthopaedic Hospital NHS Trust, Brockley Hill, Stanmore, Middlesex, HA7 4LP
* Department of Barnet and Chase Farm Hospitals NHS Trust, Barnet Hospital, Wellhouse Lane, Barnet, Hertfordshire, EN5 3DJ**

Address for Correspondence

Jonathan R Perera

Royal National Orthopaedic 

Hospital NHS Trust, Brockley Hill, Stanmore,

Middlesex, HA7 4LP

Abstract:

Vertebral fragility fractures are becoming an increasing problem in an aging population. There are multiple medical and surgical treatment options available, which can be applied to benign and malignant conditions. As the surgical treatment options are relatively new and the evidence for and against them are mixed, we summarise the current evidence base and discuss the best practise options.

J.Orthopaedics 2012;9(2)e1

Keywords:

Osteoporosis, Osteoporotic Vertebral Fragility Fractures, Kyphoplasty, 

Vertebroplasty, Vertebral Augmentation, Metastatic Spinal Tumours.


Introduction:

The WHO defines osteoporosis as ‘low bone mass…in the presence of one or more fragility fractures’[1,2].As the population ages and life expectancy increases, the prevention and treatment of osteoporosis and its sequelae is becoming a major public health concern. The majority of patients elude diagnosis until they present with a fragility fracture. Limited awareness amongst doctors means that Osteoporotic Vertebral Fragility Fractures, (OVFF), are still under-diagnosed despite their high incidence [3-22], (See figure 1).

Epidemiology

Approximately 20million people in the UK over the age of 50 are affected by osteoporosis which accounts for nearly half of all fragility fractures[8].This is expected to rise to 25million by 2020, thus increasingthe risk of a fragility fracture. 1in 2 osteoporotic women and 1 in 5osteoporotic men will suffer a fragility fracture [23,24].In fact the lifetime risk of fragility fracture is greater than the risk of breast cancer or cardiovascular disease. Theymost commonly occur in the vertebrae, proximal femur, distal radius, and proximal humerus respectively[8,10].They tend to occur earlier in life than hip fragility fractures and are at least twice as common. The prevalence of OVFF in people over the age 50 is 10-24% and increases dramatically with age[3,4].75% are due to everyday activities such as bending or lifting whereas only 25% are due to falls. One OVFF increases the risk of future OVFF, by approximately fivefold and hip fragility fracture, by approximately threefold [25-27].The mortality rate,[28-32], is increased for both symptomatic and asymptomatic OVFF and in some studiesis similar to that for hip fractures [28,33].

Diagnosis

OVFFs are correctly identified in only 2–13% of white women over the age of 60, whereas the actual prevalence is 20–30%[19,20].Failure to diagnose OVFF is a worldwide problem due in part to the lack of awareness by clinicians and poor recognition by radiologists.Patients usually complain of back pain, difficulty with activities of daily living (rising from a chair, bathing, dressing, cooking, climbing stairsand walking, [11-13]), loss of height, limitation of mobility, reduced pulmonary function, reduced gastrointestinal function and social isolation [14-18].As examination findings such as sudden height loss (unreliable indicator of fracture until it exceeds 4cm) or kyphosis are very non-specific, and therefore only 1 in 4 are picked up on clinical examination[34-37].The vast majority are found incidentally when plain radiographs are obtained for other reasons. Retrospective radiographic studies of plain radiographs in women over the age of 60 have shown that only 50% of OVFF were correctly identified [21].Bone densitometry is useful for assessing disease severity and monitoring therapy, although it is not essential to making the diagnosis of osteoporosis in a patient with fragility fracture.Magnetic Resonance Imaging, (MRI), can be used to distinguish between malignancy and chronicity of the fracture [38],(See figure 2). This can be very useful in patient selection for the different treatment options.   The presence of a fragility fracture, by definition, confirms the presence of osteoporosis. Therefore after the exclusion of malignancy and trauma, as causes for bone fragility, most clinicians will commence pharmacological therapy aimed at secondary prevention of osteoporosis.

Treatment of Vertebral Fractures

Fall prevention strategies such as weight-baring exercises, proprioceptive training with gentle stretching and balance training have been associated with a 40% reduction in the risk of falls [39].Furthermore simple modification of the environment and the appropriate use of assistive devices and footwear can reduce the incidence of such falls.

Treatment is largely determined by the presence of signs and symptoms, particularly pain. This may include physical modalities (i.e. heat, cold, ultrasound or electrical stimulation), exercise programs, pharmacological agents, nerve blocks, percutaneous vertebral augmentation (vertebroplasty and kyphoplasty), or open surgery. Pharmacologic therapy for osteoporosis is effective in patients with vertebral fractures. Clinical trials with a variety of agents including alendronate, calcitonin, raloxifene, risedronate, and teriparatide have shown 30–50% reductions in the incidence of OVFF[40-46].Although these agents reduce the risk of vertebral fracture in patients with low BMD, the absolute risk reduction is greatest in those patients with vertebral fractures[40-46].The net result is a 60% reduction in the incidence of vertebral compression fractures after one year of treatment with any agent [47].This protective effect is thought to begin as early as 6 months after initiation of therapy with the anti-resorptive drugs and lasts from at least three to four years of treatment. Historically surgical options were lengthy with prolonged anaesthesia, significant blood loss and high incidence of complications. Furthermore poor bone quality and primitive implant technology made constructs ineffective, with inadequate purchase of pedicle screws and wires cutting through bone, resulting in early construct failure and in some cases worsening of the deformity. Nowadays cases are discussed with specialist spinal units to determine best treatment and any variables that may influence surgical outcome (e.g. nutritional status)are optimised preoperatively[48].Better anaesthetic and operative techniques coupled with advancements in implant technology have greatly improved surgical outcomes. Longer constructs with multiple segmental points of fixation are employed to preserve fixation, sublaminar wires are used whenever dealing with cortical bone in the lamina, and larger pedicle screws are used for a more secure bone purchase and can be augmented with cement or bone graft.

Percutaneous Augmentation: Vertebroplasty & Kyphoplasty

Percutaneous augmentation of the vertebral body with bone cement was introduced to treat patients with vertebral compression fracture or fractures who had intractable back pain without the need for decompression of the neural elements [49-52].Vertebroplasty involves the percutaneous injection of methymethacralate into the vertebral body to splint the fracture internally thus providing pain relief and taking pressure off any neurological structures.It was first described by Galibert et al in 1987 to treat symptomatic haemangiomas of the vertebral body[53].Kyphoplasty is a slight modification of this technique described by Reiley in 1997, and refers to the insertion of a balloon tamp into the vertebral body and its subsequent inflation to increase the height of the vertebral body thus correcting the kyphotic deformity prior to injecting methymethacralate, (see diagram 1). Both procedures are usually carried out under general anaesthetic, although they can be done under local anaesthetic if augmentation is intended for less than two levels. The patient is positioned prone, with bolsters under the sternum and pelvis to try and reduce the kyphotic deformity. Under fluoroscopic guidance, an 11-gauge trochar is inserted via a posterior transpedicular approach to the vertebral body. An extrapedicular approach is used in the dorsal spine as the vertebral bodies are smaller and the pedicles less angulated. If kyphoplasty is being done, an inflatable balloon tamp is introduced through the cannula and the balloon is inflated under manometric control to try and restore the collapsed vertebra to its normal position and thus create a space within the body for the insertion of cement. (See figures 3 & 4) Antibiotic-impregnated cement (containing barium sulphate to make it radio-opaque) is then injected into the vertebral body under fluoroscopic control, paying careful attention to ensure that it does not flow back toward the spinal canal. Although the cement is generally kept cold to prolong working time and to facilitate injection through the cannula, in kyphoplasty the cement is injected in a higher viscosity state as a void has already been corrected and the kyphosis reduced [54,55].If a decompression of the neural elements is required with an OVFF this can be combined into ahybrid procedure where there is a surgical decompression with stabilisation andvertebral augmentation to gain vertebral height and reduce the kyphotic angle, (See figure 5).

Pain relief

Both procedures have demonstrated excellent short-term pain relief and facilitate early return to activity. Follow-up studies of vertebroplasty and kyphoplasty demonstrated moderate to complete pain relief in 90-95% of patients [51,56-58].The best results are obtained in those patients who were experiencing severe localised pain over the fracture site and had evidence of a recent fracture on MRI or bone scan[38], (see figure 2).The long-term results are however less clear. Several 5-year follow-up studies of vertebroplasty have shown the majority of patients had good initial pain relief which continued throughout the follow-up period and as a result 92% of patients would have the procedure done again [59].However other long term studies showed less satisfactory results after two years, with up to 29% of patients having recurrent pain of at least moderate severitydue to re-collapse at the level of the fracture or a new fracture of an adjacent non-augmented vertebra[60]. There are currently no independent long-term studies of outcome after kyphoplasty.

There has been a recent controversy in the management of OVFF after the publication of two randomised studies in August 2009, in the New England Journal of Medicine, (NEJM). Firstly Buchbinder et al, from Monash University, Australia, [61]; Then Kallmes et al, from Mayo Clinic , USA, [62]in back to back articles. Both groups performed interventional vertebroplasty against a sham control procedure without cement injection. Both articles showed a similar improvement in pain and disability post-procedure, in both intervention and control groups, at all stages of follow up. This lead to the American Academy of Orthopaedic Surgeons, (AAOS), to release new clinical guidelines in September 2010, based largely on these two trials, against the use of vertebroplasty in neurologically intact patients. There are some points concerning the NEJM papers, which may reduce the power of these publications. They are both small sized, with no analysis of chronicity, (including fractures up to 1 year old); the sham procedure will have a greater placebo power than pure conservative treatment. One trial had a statistically significant crossover rate from placebo to vertebroplasty [62].Thetrials results do not apply to vertebroplasty for other indications.

Soon after this Klazen et al, from The Netherlands and Belgium, released the Vertos II trial results[63].They randomly compared vertebroplasty against conservative treatment, and showed that there was a statistically significant improvement in the vertebroplasty group compared with the conservative group. This study also has its own weaknesses, mainly an inability to blind the trial to patient / physician / assessor. Kumar et al have recently published a prospective trial comparing vertebroplasty and kyphoplasty [86]. The have demonstrated that both vertebroplasty and kyphoplasty will improve pain, functional disability and quality of life. They have also shown that kyphoplasty shows better results than vertebroplasty. This trial has its weaknesses also with small study sizes and short follow-ups.All four trials have their strengths and weaknesses, but they both have differing opinions, which have fuelled this controversy more.  

Complications

The majority of complications are caused by patient positioning, suboptimal trochar placement or poor attention to cement flow during injection. Rib fractures sometimes occur from excessive pressure on the thorax despite careful attention to positioning [51,64,65].Local pain, radiculopathy, or transient fever lasting up to four days post-operatively may occur as a result of inflammation at the injection site or the exothermic effects of the cement. Sometimes unreacted monomer from the cement can enter the systemic circulation resulting in cardiopulmonary effects. The largest studies quote complication rates of up to 4.4% in vertebroplasty and 0.2% in kyphoplasty [66].The most worrying complication of either procedure is cement leakage. Cement can leak through cortical defects into the spinal canal potentially risking neurological deficit, ranging from transient partial motor or sensory deficit to total paraplegiaalthough it does not usually result in adverse effects[64,66-69].The actual incidence of cement leakage is not known although it is probably higher than expected, with CT picking up cement leak 1.5times more frequently than routine post-operative radiographs[60].Cement leakage appears to be more common in vertebroplasty than kyphoplasty[70]. Although the reason has not yet been established, it is thought to be related to the compaction of bone by the balloon in kyphoplasty,forming a boundary preventing leakage.  

Restoration of vertebral height

The wedging of the vertebral body in many OVFF is not fixed and therefore leaves a residual deformity which is likely to progress over time, culminating in loss of height and kyphosis[71].Restoration of this deformity has the theoretical benefit of improving cosmetic appearance, pulmonary and gastrointestinal function, and reducing the risk of neurologic deficit. The chance of achieving a maximal correction is higher if the procedure is done within 3 months of the OVFF although best results are obtained within the first 2 weeks. Most lost height can be restored simply by a combination of careful positioning and percutaneous augmentation, with anterior vertebral body height increases from 83-99% [38,64,67].There are no studies directly comparing height restoration in vertebroplasty and kyphoplasty. Those who have fixed fractures, however, do not show any appreciable restoration of vertebral height.

Secondary vertebral fractures 11.5% of women with a single OVFF and 24% of women with two or more OVFF are likely to sustain a new fracture within a year, (only 23% of these will be symptomatic)[27].It is unclear whether the injection of cement, which changes the stiffness of the vertebral body, increases the likelihood of fractures at adjacent levels. New fractures were more likely in patients who had had more than one single fracture previously [72-74]. Neither procedure is thought to increase the risk of new fractures at adjacent levels.

Biomechanics of vertebral augmentation The effects of vertebral augmentation on spinal biomechanics are still unclear. There is much to be learned about the optimal strength and stiffness required in the management of these fractures, the effects of varying cement volumes or fill patterns on pain relief and on adjacent segments.Initially it was though that best results would be achieved by filling the vertebral body with the maximum volume of cement, although it is now evident that smaller volumes may more appropriately restore the biomechanical properties of the vertebral body. In fact the volume of cement used is directly proportional to the stiffness and strength that is achieved so that a volume fraction as small as 15% may be adequate to restore the stiffness of the vertebral body to normal [75].Larger volumes increase the stiffness of the vertebra potentially increasing the riskof fractures in adjacent non-augmented vertebra. Furthermore larger cement volumes are difficult to place accurately, and if distributed asymmetrically, promote single sided load transfer and potential toggle[75,76].

Alternative materials for vertebral augmentation

PMMA is the main material routinely usedin percutaneous vertebral augmentation as it is a familiar material, easy to handle, radiopaque, provides the necessary strength and stiffness and is inexpensive. However it does not have osseoconductive or osseoinductive properties, the temperatures generated during polymerisation can damage surrounding tissues, unreacted monomer has systemic cardiopulmonary side effects, excessive inherent stiffness can have a detrimental mechanical effect on adjacent vertebrae and it is not remodelled by creep over time.

Alternative biodegradable materials have been tested, including calcium phosphate, hydroxyapatite, and coral granules although they have had variable results to date [76-81].Unlike PMMA, they harden within metaphyseal bone without producing much heat, minimising damage to surrounding tissues, new bone is laid down on it and eventually replaces it. Unfortunately mineral cements have a higher viscosity which prevents interstitial diffusion within the vertebral body, handling characteristics that differ from PMMA and a higher cost. However early reports are promising with patients undergoing vertebral augmentation for OVFF with bioactive calcium phosphate cement having substantial pain relief, and resuming normal activity within a short period of time and no radiological evidence of deformity progression or radiolucency several months down the line[82].

NICE Guidance:

Percutaneous Vertebroplasty - September 2003 [83]

Balloon Kyphoplasty - April 2006[84]

The latest guidelines recommend that percutaneous vertebroplasty and balloon kyphoplasty should only be used in patients with back painrefractory to othertreatments. It is indicated in OVFF, vertebral haemangioma and vertebral body tumours.Specialist opinion is currently divided, with some believing that the procedure could change the future management of OVFF whereas others have shown concern about an unnecessary procedure and the risk of adjunctive vertebral fractures.These procedures should only be carried out in centres with a multidisciplinary spinal team (spinal surgeon and a radiologist), acute spinal surgery facilities, suitable training for the team members, informed consent and monitoring of the procedure results.There was also a special mention to follow themanufacturer’s instructions in making the cement to reduceits complication rates, namely leakage and embolisation.

Conclusion

OVFF are a clinical indicator of decreased bone mineral density. Therefore as the population continues to age, OVFF will become more prevalent, having a huge socio-economic impact on the NHS. These fractures usually occur in an older age group that but are usually asymptomatic and require minimal or no treatment. The management of patients with painful fractures however is very challenging, with the mainstay of treatment being some combination of rest, bracing, and medications. Operative stabilisation is reserved for patients with an impending or actual neurological deficit.

Vertebral augmentation is a relatively new technique that uses PMMA to internally splint the vertebral body with the aim of relieving pain. Procedural complications can be avoided by careful attention to positioning, and the use of good technique. The short-term pain relief is excellent, although long-term efficacy is still unclear. Vertebral augmentation also offers the opportunity to restore height of the fractured vertebra body by a combination of positioning the patient in extension and by using an inflatable balloon. Although it has been postulated that this may reduce secondary morbidity or mortality in the long-term, it has yet to be proven.

As shown by recent publications the evidence for and against managing OVFF with vertebroplasty is divided and larger scale trials are required. There have also not been any large scale trials comparing kyphoplasty to conservative / placebo treatment.

Vertebral augmentation alters the mechanical properties of the vertebral body. It is thought that larger volumes of cement may increase the stresses at adjacent levels and increase the likelihood of fractures at those levels. Therefore there is great interest in the development of bone cements with mechanical properties similar to that of bone with long-term biocompatibility.

 

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  • This is a peer reviewed paper 

    Please cite as :Jonathan R Perera,Osteoporotic Vertebral Fragility Fractures – Treatment and Management

    J.Orthopaedics 2012;9(2)e1

    URL: http://www.jortho.org/2012/9/2/e1

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