Percutaneous vertebroplasty: efficacy in the management of pain related to acute vertebral compression fractures
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As New Zealand’s ageing population grows, the prevalence of osteoporosis and related complications grow with it. Vertebral body compression fractures (VCF) are the most common osteoporotic fracture, occurring in 20% of people over the age of 70 years.[[1]] VCFs generally present with significant pain and loss of mobility. They are diagnosed by correlating clinical history and examination with imaging. Radiographic findings on X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) include loss of vertebral body height, high density suggestive of bone compression, and sometimes overt fractures. A decrease in vertebral height of 20% or more, or a decrease of at least 4mm compared with baseline height is considered positive for compression fracture.[[2]]
To determine if a fracture is acute or chronic, clinical history is correlated with imaging. Evidence of acute fracture includes cortical breaking or impaction of trabeculae. The absence of these signs indicates a chronic fracture. MRI characteristically demonstrates oedema in acute fractures with a high bone marrow signal on short-TI inversion recovery (STIR) weighted scans, and MRI can help determine the age of a fracture. Isotope bone scans can also differentiate between acute and chronic compression fractures, as acute fractures will appear “hot” with increased radio-isotope up-take.[[3,4]]
As pain is the hallmark feature of VCF, analgesia is paramount in management.[[5]] Elderly patients, who are more predisposed to developing acute VCFs, are at greater risk of developing adverse effects of analgesia such as constipation, falls and nausea.[[6]] They are also at high risk of becoming deconditioned due to a prolonged period of limited mobility and are prone to developing secondary conditions such as bed sores and pneumonia.
Standard practice has been to manage a VCF with oral analgesia, and perform percutaneous vertebroplasty or kyphoplasty (“vertebral augmentation”, or VA) if there has been no improvement in pain. Percutaneous vertebroplasty is a minimally invasive procedure in which radio-opaque cement (polymethyl methacrylate- PMMA) is injected into the affected vertebral bodies under fluoroscopic guidance.[[3]] This in turn leads to stabilisation of the fracture and provides effective pain relief.
This retrospective single-centre study was undertaken to investigate the efficacy of vertebroplasty as performed at Middlemore Hospital. This is specifically in patients who had one or more acute vertebral compression fractures, all aged 12 weeks or less and positive for acute fracture-oedema on MRI. By doing this, the study was able to isolate the group thought to better respond to vertebroplasty as a means of analgesia. We hypothesised that there would be an improvement in pain scores in those that had received the procedure.
Aim
To determine if percutaneous vertebroplasty is effective in managing pain in patients with acute vertebral body compression fractures.
Method
Design: retrospective study
Setting
Fifteen consecutive patients underwent percutaneous vertebroplasty for the treatment of one or more acute vertebral insufficiency fractures at Middlemore Hospital, Counties Manukau District Health Board (CMDHB), Auckland between 2018 and 2021. All 15 patients in the cohort had a fracture age of 12 weeks or less, with the presence of increased bone marrow signal on MRI.
Prior to collating data for the study, approval was gained from the Auckland Health Research Ethics Committee (reference number: AH23296).
Participants were contacted over the phone and consented to participate in the study. They were surveyed with a questionnaire, which covered pain scores (based on the numeric pain rating scale), amount of analgesia used, and mobility pre- and post-procedure.
A secondary wing of the study analysed doses of opioid analgesia consumed prior to and following the procedure, according to outpatient medicine dispensing records. Community dispensing records were obtained to analyse the doses of opioids dispensed to look for trends in use of analgesia pre- and post-procedure.
Participants
Of the fifteen patients in the initial group, four patients were deceased, two were not contactable, and one declined to participate in the survey, resulting in eight out of fifteen that participated in the survey element.
Results
View Figures 1–6.
The illustrative vignette below demonstrates clinical history and imaging used in the process of selection, post procedure imaging and clinical outcome.
An elderly female presented with acute lumbar spine pain following a fall. She experienced severe pain requiring opiates and could not mobilise during a week-long admission. MRI confirmed the suspicious fracture of L3 but also the plain film and CT occult fracture of L4.
Figures 2–6
After two-level vertebroplasty the patient had immediate pain relief was able to mobilise and was discharged the following day on simple analgesia.
Of the eight patients in our study that participated in the survey, six patients described improvement in pain scores immediately after the procedure. Of the six, all reported either improvement or consistently similar improved pain levels 2 weeks and 1 month following the procedure. One patient reported improvement after 2 weeks, while one reported no improvement at all in pain levels following the procedure.
The average pain score among the participants preceding the procedure was 9.25/10. The average pain score immediately following the procedure was 4.375/10. The average pain scores at 2 weeks and 1 month were 3.75/10 and 2.25/10 respectively.
Of the eight participants surveyed, six felt they had improved mobility following the percutaneous vertebroplasty procedure, and two felt no improvement in mobility.
Of the four deceased (all causes not pertaining to the procedure itself), clinical notes/letters identified improvement in pain levels in all four, though not quantified as a pain score.
There were no procedure-related complications in any patient.
Of the fifteen patients, ten showed decreased amounts or complete cessation of opioid analgesia dispensed within the course of 4 weeks. Four patients had an increased dose of opiates following the initial fracture, which stayed the same post procedure. Interestingly, the one patient that reported no improvement in pain scores post procedure had decreased prescription of opiate analgesia in the community.
Discussion
Percutaneous vertebroplasty is a modality of treatment that was first reported to be successful over forty years ago.[[3]] When the procedure was initially introduced at Middlemore Hospital, CMDHB, Auckland (the same hospital where this study was conducted), there was generally very good utilisation. An early study there in 2004 describes five patients with MRI evidence of acute VCF treated over a 10-month period. This small series showed good response, with near immediate improvement in pain scores for most, and delayed improvement (over the course of 6 months) in some.[[7]] One of the authors (SPH) noted the rapid uptake of the procedure over the years up to 2009, averaging around 10 cases per year for this 800-bed tertiary care public hospital.
Utilisation of vertebroplasty—a brief overview of the timeline
In the period 2004 to 2009 there was a 188% increase in VA procedures in the USA.[[8]] As the procedure became more studied, there was more controversy surrounding the efficacy of vertebroplasty.
Randomised control trials (RCTs) comparing vertebroplasty with sham procedures/placebo reported that the procedure was not effective, and not more efficacious than placebo.[[9,10]] The most widely discussed article was published in The New England Journal of Medicine (NEJM) in 2009 by Buchbinder et al.[[10]] In 2015, procedure utilisation was studied in the Medicare population in the United States. The studied population reported a 15.6% decline in volume of VA. VA includes VP and the similar procedure of percutaneous kyphoplasty, which involves an attempt to restore spinal alignment by using devices, such as balloons, to raise vertebral body height, then using cement. From a peak in 2008, after the NEJM pub¬lication there was a persistent decline in VA procedures up to 2018 with vertebroplasty episodes in the Medicare population falling up to 66% and VA inflation-adjusted expenditure falling 40%.[[11,12]]
There have been concerns about selection criteria allowing chronic fractures into these RCTs. Since 2009, other RCTs have been carried out to study the efficacy of vertebroplasty in acute VCF, and reported treatment as superior to placebo.[[13–15]] A multicentre randomised double-blind placebo controlled trial (VAPOUR) was conducted by Clarke et al. in 2015. The study hypothesised that early intervention by vertebroplasty is key to the management of the VCF. The VAPOUR trial had a very strict inclusion criteria of less than 6 weeks fracture age with an average fracture age of 2.8 weeks. The trial demonstrated statistically more effective analgesia in the treatment group. There was also a decrease in the length of hospital stay by 6 days and a significant decrease in the Roland Morris Disability score.[[13]]
A 2018 Cochrane meta-analysis of all vertebroplasty RCTs concluded that vertebroplasty is not more efficacious in the management of the VCF.[[16]]
Dr William Clark, the primary investigator in the VAPOUR trial, eloquently described the drawbacks of the Cochrane metanalysis in an article published in The British Medical Journal (BMJ).[[17]] Trials that showed overall better outcomes in the test groups had a strict inclusion criteria of acute compression fractures. Referenced in this response, were the VAPOUR trial (mean fracture age 2.8 weeks); the Yang et al. trial (mean fracture age 1.1 weeks),[[18]] both of which showed better outcomes in the treatment group. The other trials referenced, in contrast, include VERTOS IV (mean fracture duration 6.1 weeks),[[19]] Buchbinder et al. (12 weeks),[[10]] Kallmes et al. (23 weeks),[[9]] which all had an older mean fracture age, and showed no significant improvement in analgesia between test and sham groups. Fracture age plays a critical role in the effectiveness of the vertebroplasty procedure.
Comparison of this study with others
The study, like the VAPOUR trial recruited only inpatients, with unmanageable pain requiring hospitalisation. This is unlike the VERTOS IV and Kallmes et al. trials which only recruited outpatients. Due to the comparatively strict inclusion criteria, this study only observed analgesic effect in the setting of an acute VCF. This is unlike some of the aforementioned studies which allowed for older, more chronic fractures to be included.
Strengths and limitations of this study
This study, like the VAPOUR trial, attempts to study the efficacy of vertebroplasty in the acute setting, i.e., fracture age of 12 weeks or less. However, the study design has limitations. These are the sample size and bias associated with retrospective analysis, together with recall bias. Some of the patients have also had further injuries and health issues after their procedures which resulted in requirement of analgesia. However, there was a consistent recollection of a pain-free period post procedure in those that reported improvement. There were good participation rates particularly given the length of time since the index procedure. Of the nine patients that were contacted, eight agreed to be surveyed.
Main findings of this study
Of those patients surveyed in our study, 75% showed immediate and sustained improvement in pain and mobility of which further improved over time. The average pain score of those surveyed halved from 9.25 to 4.375 immediately after the procedure. Similar reports of immediate improvement have anecdotally been described by others.[[7]] The results of this study indicate that VP is a relatively reliable, safe and acceptable means of providing analgesia in acute VCFs that would not as easily be managed with pharmacologic therapy, mainly using opioids.
Implications for practice
VCFs are associated with mortality risk. From the first VCF, 3-year mortality has been found to be 46.1%, significantly higher and around double that of matched control groups, with similar and consistent findings at 5 years and 7 years post VCF, regardless of age or sex.[[20]]
A review of the 100% USA Medicare data set 2005–2009 found that the non-VA group had a 55% higher adjusted risk of mortality than the balloon kyphoplasty and 25% higher than the vertebroplasty treated groups. This non-operated group had higher risks of pneumonia, myocardial infarction, deep vein thrombosis and urinary tract infection.[[21]]
Changes in treatment patterns and outcomes of VCF before and following the 2009 sham trials have also been studied using US Medicare data. Overall, the propensity adjusted mortality of VCF increased by 4% after 2009. The 10-year mortality risk following VCF was 19% lower in the balloon kyphoplasty group, and 7% lower in the vertebroplasty group compared with the non-operative group.[[22]] Furthermore, in a highly clinically useful approach it has been estimated from this data that the VCF number needed to treat to “save a life” may be as low as 11.9.[[23]] There are theoretical benefits of balloon kyphoplasty versus vertebroplasty but these have not been adequately studied. Patient selection and suitability criteria as well as operator bias are likely to favour younger, fitter patients being offered balloon kyphoplasty.
With an ageing population, VCFs will rise in number. A 2007 analysis of the economic burden of osteoporosis in New Zealand documented 27,994 VCFs, with $NZD 212 million spent on treating fractures, and $NZD 85 million for care after fractures. A significant proportion of those costs were attributed to hospitalisation.[[24]] Costing obtained from Middlemore Hospital showed that a single night in a rehabilitation ward costs just over $2,600 per night (with most patients requiring over a week as inpatients to manage their pain). An MRI of the thoracolumbar spine costs $1,854 and the vertebroplasty procedure costs $2,596. The data from this study points to an immediate improvement in pain levels and mobility for these patients through percutaneous vertebroplasty, targeted to the acute period post fracture where MRI confirms the acute bone marrow oedema and thereby accurately identifies the vertebral level(s) to target. The VAPOUR trial points toward an overall reduction in hospital stay and a decrease in the economic and resource burden of each fracture event.[[9]]
Future directions
This paper will hopefully draw the attention of physicians caring for patients with VCFs to the weaknesses in the earlier sham trials that have reduced the utilisation of VA worldwide, and to reaffirm that VCF is not simply a benign condition requiring analgesia. VCF is strongly associated with mortality and carries a high economic burden. Suitable patients with fracture oedema demonstrated on MRI, treated within 12 weeks, and preferably earlier, by percutaneous VA are likely to respond rapidly, reliably and with a high safety margin, reducing morbidity, mortality and healthcare costs. Clinical care pathways should incorporate appropriate investigation and consideration of these patients for VA treatment.
Summary
Abstract
Aim
Historically, both acute and chronic vertebral compression fractures (VCF) have been managed with vertebral augmentation procedures such as percutaneous vertebroplasty (VP). Recently, however, the trend has shifted to manage VCF pharmacotherapeutically. This study aims to determine if VP is effective for managing pain related to acute VCF (≤12 weeks).
Method
This study retrospectively surveyed 8 of 15 patients that underwent VP at Middlemore Hospital between 2018 and 2021. All had VCF aged ≤12 weeks, and presence of increased bone marrow signal on magnetic resonance imaging (MRI). The survey reviewed pain levels (via numeric score), opiate analgesia dispensation, and mobility levels pre- and post-procedure.
Results
Results showed post-procedure improvement in pain levels in 75% of individuals, which were maintained over the two- and four-week marks. There was an improvement in mobility in 75% of patients at 4 weeks, and 66% had decreased dispensation or complete cessation of opioid analgesia 4 weeks post procedure.
Conclusion
This study shows that VP correlates with overall improvement in pain scores, opiate use and mobility in the sample group with VCF aged ≤12 weeks. Hopefully the results of this study will encourage physicians to consider vertebroplasty as a method of achieving adequate analgesia in this demographic of patients.
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cohen LD. Fractures of the osteoporotic spine. Orthop Clin North Am. 1990 Jan;21(1):143-50. PMID: 2404233.
2) Nevitt MC, Ettinger B, Black DM et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001. PMID: 9599190.
3) Deramond H, Depriester C, Toussaint P, Galibert P. Percutaneous Vertebroplasty. Semin Musculoskelet Radiol. 1997;1(2):285-296. doi: 10.1055/s-2008-1080150. PMID: 11387078.
4) Yamato M, Nishimura G, Kuramochi E, et al. (1998) MR appearance at different ages of osteoporotic compression fractures of the vertebrae. Radiat Med 16:329-334. PMID: 9862153.
5) Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004 Jan 1;69(1):111-6. PMID: 14727827.
6) Goldstein CL, Chutkan NB, Choma TJ, Orr RD. Management of the Elderly With Vertebral Compression Fractures. Neurosurgery. 2015 Oct;77 Suppl 4:S33-45. doi: 10.1227/NEU.0000000000000947. PMID: 26378356.
7) Doyle. A, Hawkins. S, Tran. J (2004). Percutaneous vertebroplasty for osteoporotic fracture: Preliminary experience at Middlemore Hospital. N Z Med J. 117. U1101.
8) Manchikanti L, Sanapati J, Pampati V et al. Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post2009 Trials. Curr Pain Headache Rep. 2020 Apr 14;24(5):22. doi: 10.1007/s11916-020-00850-2. PMID: 32291587.
9) Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563. Erratum in: N Engl J Med. 2012 Mar 8;366(10):970. PMID: 19657122; PMCID: PMC2930487.
10) Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429. PMID: 19657121.
11) Rabei R, Patel K, Ginsburg M et al. Percutaneous Vertebral Augmentation for Vertebral Compression Fractures: National Trends in the Medicare Population (2005-2015). Spine (Phila Pa 1976). 2019 Jan 15;44(2):123-133. doi: 10.1097/BRS.0000000000002893. PMID: 30562331.
12) Manchikanti L, Senapathi SHV, Milburn JM, et al. Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018. Pain Physician. 2021 Sep;24(6):401-415. PMID: 34554681.
13) Clark W, Bird P, Gonski P et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebocontrolled trial. Lancet. 2016 Oct 1;388(10052):1408-1416. doi: 10.1016/S01406736(16)31341-1. Epub 2016 Aug 17. Erratum in: Lancet. 2017 Feb 11;389(10069):602. PMID: 27544377.
14) Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011 May;14(5):561-9. doi: 10.3171/2010.12.SPINE10286. Epub 2011 Mar 4. PMID: 21375382.
15) Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9. PMID: 20701962.
16) Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3. Update in: Cochrane Database Syst Rev. 2018 Nov 06;11:CD006349. PMID: 29618171; PMCID: PMC6494647.
17) Clark W, Bird P, Diamond T, et al. Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ Evidence-Based Medicine. 2019;25(3):85-89.
18) Yang E-Z , Xu J-G, Huang G-Z et al. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila PA 1976) 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.
19) Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551. doi: 10.1136/bmj.k1551. Erratum in: BMJ. 2018 Jul 4;362:k2937. Smeet AJ [corrected to Smeets AJ]. PMID: 29743284; PMCID: PMC5941218.
20) Lau E, Ong K, Kurtz S et al. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86. doi: 10.2106/JBJS.G.00675. PMID: 18594096.
21) Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097/BRS.0000000000000992. PMID: 26020845.
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Percutaneous vertebroplasty: efficacy in the management of pain related to acute vertebral compression fractures
View Article PDF
As New Zealand’s ageing population grows, the prevalence of osteoporosis and related complications grow with it. Vertebral body compression fractures (VCF) are the most common osteoporotic fracture, occurring in 20% of people over the age of 70 years.[[1]] VCFs generally present with significant pain and loss of mobility. They are diagnosed by correlating clinical history and examination with imaging. Radiographic findings on X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) include loss of vertebral body height, high density suggestive of bone compression, and sometimes overt fractures. A decrease in vertebral height of 20% or more, or a decrease of at least 4mm compared with baseline height is considered positive for compression fracture.[[2]]
To determine if a fracture is acute or chronic, clinical history is correlated with imaging. Evidence of acute fracture includes cortical breaking or impaction of trabeculae. The absence of these signs indicates a chronic fracture. MRI characteristically demonstrates oedema in acute fractures with a high bone marrow signal on short-TI inversion recovery (STIR) weighted scans, and MRI can help determine the age of a fracture. Isotope bone scans can also differentiate between acute and chronic compression fractures, as acute fractures will appear “hot” with increased radio-isotope up-take.[[3,4]]
As pain is the hallmark feature of VCF, analgesia is paramount in management.[[5]] Elderly patients, who are more predisposed to developing acute VCFs, are at greater risk of developing adverse effects of analgesia such as constipation, falls and nausea.[[6]] They are also at high risk of becoming deconditioned due to a prolonged period of limited mobility and are prone to developing secondary conditions such as bed sores and pneumonia.
Standard practice has been to manage a VCF with oral analgesia, and perform percutaneous vertebroplasty or kyphoplasty (“vertebral augmentation”, or VA) if there has been no improvement in pain. Percutaneous vertebroplasty is a minimally invasive procedure in which radio-opaque cement (polymethyl methacrylate- PMMA) is injected into the affected vertebral bodies under fluoroscopic guidance.[[3]] This in turn leads to stabilisation of the fracture and provides effective pain relief.
This retrospective single-centre study was undertaken to investigate the efficacy of vertebroplasty as performed at Middlemore Hospital. This is specifically in patients who had one or more acute vertebral compression fractures, all aged 12 weeks or less and positive for acute fracture-oedema on MRI. By doing this, the study was able to isolate the group thought to better respond to vertebroplasty as a means of analgesia. We hypothesised that there would be an improvement in pain scores in those that had received the procedure.
Aim
To determine if percutaneous vertebroplasty is effective in managing pain in patients with acute vertebral body compression fractures.
Method
Design: retrospective study
Setting
Fifteen consecutive patients underwent percutaneous vertebroplasty for the treatment of one or more acute vertebral insufficiency fractures at Middlemore Hospital, Counties Manukau District Health Board (CMDHB), Auckland between 2018 and 2021. All 15 patients in the cohort had a fracture age of 12 weeks or less, with the presence of increased bone marrow signal on MRI.
Prior to collating data for the study, approval was gained from the Auckland Health Research Ethics Committee (reference number: AH23296).
Participants were contacted over the phone and consented to participate in the study. They were surveyed with a questionnaire, which covered pain scores (based on the numeric pain rating scale), amount of analgesia used, and mobility pre- and post-procedure.
A secondary wing of the study analysed doses of opioid analgesia consumed prior to and following the procedure, according to outpatient medicine dispensing records. Community dispensing records were obtained to analyse the doses of opioids dispensed to look for trends in use of analgesia pre- and post-procedure.
Participants
Of the fifteen patients in the initial group, four patients were deceased, two were not contactable, and one declined to participate in the survey, resulting in eight out of fifteen that participated in the survey element.
Results
View Figures 1–6.
The illustrative vignette below demonstrates clinical history and imaging used in the process of selection, post procedure imaging and clinical outcome.
An elderly female presented with acute lumbar spine pain following a fall. She experienced severe pain requiring opiates and could not mobilise during a week-long admission. MRI confirmed the suspicious fracture of L3 but also the plain film and CT occult fracture of L4.
Figures 2–6
After two-level vertebroplasty the patient had immediate pain relief was able to mobilise and was discharged the following day on simple analgesia.
Of the eight patients in our study that participated in the survey, six patients described improvement in pain scores immediately after the procedure. Of the six, all reported either improvement or consistently similar improved pain levels 2 weeks and 1 month following the procedure. One patient reported improvement after 2 weeks, while one reported no improvement at all in pain levels following the procedure.
The average pain score among the participants preceding the procedure was 9.25/10. The average pain score immediately following the procedure was 4.375/10. The average pain scores at 2 weeks and 1 month were 3.75/10 and 2.25/10 respectively.
Of the eight participants surveyed, six felt they had improved mobility following the percutaneous vertebroplasty procedure, and two felt no improvement in mobility.
Of the four deceased (all causes not pertaining to the procedure itself), clinical notes/letters identified improvement in pain levels in all four, though not quantified as a pain score.
There were no procedure-related complications in any patient.
Of the fifteen patients, ten showed decreased amounts or complete cessation of opioid analgesia dispensed within the course of 4 weeks. Four patients had an increased dose of opiates following the initial fracture, which stayed the same post procedure. Interestingly, the one patient that reported no improvement in pain scores post procedure had decreased prescription of opiate analgesia in the community.
Discussion
Percutaneous vertebroplasty is a modality of treatment that was first reported to be successful over forty years ago.[[3]] When the procedure was initially introduced at Middlemore Hospital, CMDHB, Auckland (the same hospital where this study was conducted), there was generally very good utilisation. An early study there in 2004 describes five patients with MRI evidence of acute VCF treated over a 10-month period. This small series showed good response, with near immediate improvement in pain scores for most, and delayed improvement (over the course of 6 months) in some.[[7]] One of the authors (SPH) noted the rapid uptake of the procedure over the years up to 2009, averaging around 10 cases per year for this 800-bed tertiary care public hospital.
Utilisation of vertebroplasty—a brief overview of the timeline
In the period 2004 to 2009 there was a 188% increase in VA procedures in the USA.[[8]] As the procedure became more studied, there was more controversy surrounding the efficacy of vertebroplasty.
Randomised control trials (RCTs) comparing vertebroplasty with sham procedures/placebo reported that the procedure was not effective, and not more efficacious than placebo.[[9,10]] The most widely discussed article was published in The New England Journal of Medicine (NEJM) in 2009 by Buchbinder et al.[[10]] In 2015, procedure utilisation was studied in the Medicare population in the United States. The studied population reported a 15.6% decline in volume of VA. VA includes VP and the similar procedure of percutaneous kyphoplasty, which involves an attempt to restore spinal alignment by using devices, such as balloons, to raise vertebral body height, then using cement. From a peak in 2008, after the NEJM pub¬lication there was a persistent decline in VA procedures up to 2018 with vertebroplasty episodes in the Medicare population falling up to 66% and VA inflation-adjusted expenditure falling 40%.[[11,12]]
There have been concerns about selection criteria allowing chronic fractures into these RCTs. Since 2009, other RCTs have been carried out to study the efficacy of vertebroplasty in acute VCF, and reported treatment as superior to placebo.[[13–15]] A multicentre randomised double-blind placebo controlled trial (VAPOUR) was conducted by Clarke et al. in 2015. The study hypothesised that early intervention by vertebroplasty is key to the management of the VCF. The VAPOUR trial had a very strict inclusion criteria of less than 6 weeks fracture age with an average fracture age of 2.8 weeks. The trial demonstrated statistically more effective analgesia in the treatment group. There was also a decrease in the length of hospital stay by 6 days and a significant decrease in the Roland Morris Disability score.[[13]]
A 2018 Cochrane meta-analysis of all vertebroplasty RCTs concluded that vertebroplasty is not more efficacious in the management of the VCF.[[16]]
Dr William Clark, the primary investigator in the VAPOUR trial, eloquently described the drawbacks of the Cochrane metanalysis in an article published in The British Medical Journal (BMJ).[[17]] Trials that showed overall better outcomes in the test groups had a strict inclusion criteria of acute compression fractures. Referenced in this response, were the VAPOUR trial (mean fracture age 2.8 weeks); the Yang et al. trial (mean fracture age 1.1 weeks),[[18]] both of which showed better outcomes in the treatment group. The other trials referenced, in contrast, include VERTOS IV (mean fracture duration 6.1 weeks),[[19]] Buchbinder et al. (12 weeks),[[10]] Kallmes et al. (23 weeks),[[9]] which all had an older mean fracture age, and showed no significant improvement in analgesia between test and sham groups. Fracture age plays a critical role in the effectiveness of the vertebroplasty procedure.
Comparison of this study with others
The study, like the VAPOUR trial recruited only inpatients, with unmanageable pain requiring hospitalisation. This is unlike the VERTOS IV and Kallmes et al. trials which only recruited outpatients. Due to the comparatively strict inclusion criteria, this study only observed analgesic effect in the setting of an acute VCF. This is unlike some of the aforementioned studies which allowed for older, more chronic fractures to be included.
Strengths and limitations of this study
This study, like the VAPOUR trial, attempts to study the efficacy of vertebroplasty in the acute setting, i.e., fracture age of 12 weeks or less. However, the study design has limitations. These are the sample size and bias associated with retrospective analysis, together with recall bias. Some of the patients have also had further injuries and health issues after their procedures which resulted in requirement of analgesia. However, there was a consistent recollection of a pain-free period post procedure in those that reported improvement. There were good participation rates particularly given the length of time since the index procedure. Of the nine patients that were contacted, eight agreed to be surveyed.
Main findings of this study
Of those patients surveyed in our study, 75% showed immediate and sustained improvement in pain and mobility of which further improved over time. The average pain score of those surveyed halved from 9.25 to 4.375 immediately after the procedure. Similar reports of immediate improvement have anecdotally been described by others.[[7]] The results of this study indicate that VP is a relatively reliable, safe and acceptable means of providing analgesia in acute VCFs that would not as easily be managed with pharmacologic therapy, mainly using opioids.
Implications for practice
VCFs are associated with mortality risk. From the first VCF, 3-year mortality has been found to be 46.1%, significantly higher and around double that of matched control groups, with similar and consistent findings at 5 years and 7 years post VCF, regardless of age or sex.[[20]]
A review of the 100% USA Medicare data set 2005–2009 found that the non-VA group had a 55% higher adjusted risk of mortality than the balloon kyphoplasty and 25% higher than the vertebroplasty treated groups. This non-operated group had higher risks of pneumonia, myocardial infarction, deep vein thrombosis and urinary tract infection.[[21]]
Changes in treatment patterns and outcomes of VCF before and following the 2009 sham trials have also been studied using US Medicare data. Overall, the propensity adjusted mortality of VCF increased by 4% after 2009. The 10-year mortality risk following VCF was 19% lower in the balloon kyphoplasty group, and 7% lower in the vertebroplasty group compared with the non-operative group.[[22]] Furthermore, in a highly clinically useful approach it has been estimated from this data that the VCF number needed to treat to “save a life” may be as low as 11.9.[[23]] There are theoretical benefits of balloon kyphoplasty versus vertebroplasty but these have not been adequately studied. Patient selection and suitability criteria as well as operator bias are likely to favour younger, fitter patients being offered balloon kyphoplasty.
With an ageing population, VCFs will rise in number. A 2007 analysis of the economic burden of osteoporosis in New Zealand documented 27,994 VCFs, with $NZD 212 million spent on treating fractures, and $NZD 85 million for care after fractures. A significant proportion of those costs were attributed to hospitalisation.[[24]] Costing obtained from Middlemore Hospital showed that a single night in a rehabilitation ward costs just over $2,600 per night (with most patients requiring over a week as inpatients to manage their pain). An MRI of the thoracolumbar spine costs $1,854 and the vertebroplasty procedure costs $2,596. The data from this study points to an immediate improvement in pain levels and mobility for these patients through percutaneous vertebroplasty, targeted to the acute period post fracture where MRI confirms the acute bone marrow oedema and thereby accurately identifies the vertebral level(s) to target. The VAPOUR trial points toward an overall reduction in hospital stay and a decrease in the economic and resource burden of each fracture event.[[9]]
Future directions
This paper will hopefully draw the attention of physicians caring for patients with VCFs to the weaknesses in the earlier sham trials that have reduced the utilisation of VA worldwide, and to reaffirm that VCF is not simply a benign condition requiring analgesia. VCF is strongly associated with mortality and carries a high economic burden. Suitable patients with fracture oedema demonstrated on MRI, treated within 12 weeks, and preferably earlier, by percutaneous VA are likely to respond rapidly, reliably and with a high safety margin, reducing morbidity, mortality and healthcare costs. Clinical care pathways should incorporate appropriate investigation and consideration of these patients for VA treatment.
Summary
Abstract
Aim
Historically, both acute and chronic vertebral compression fractures (VCF) have been managed with vertebral augmentation procedures such as percutaneous vertebroplasty (VP). Recently, however, the trend has shifted to manage VCF pharmacotherapeutically. This study aims to determine if VP is effective for managing pain related to acute VCF (≤12 weeks).
Method
This study retrospectively surveyed 8 of 15 patients that underwent VP at Middlemore Hospital between 2018 and 2021. All had VCF aged ≤12 weeks, and presence of increased bone marrow signal on magnetic resonance imaging (MRI). The survey reviewed pain levels (via numeric score), opiate analgesia dispensation, and mobility levels pre- and post-procedure.
Results
Results showed post-procedure improvement in pain levels in 75% of individuals, which were maintained over the two- and four-week marks. There was an improvement in mobility in 75% of patients at 4 weeks, and 66% had decreased dispensation or complete cessation of opioid analgesia 4 weeks post procedure.
Conclusion
This study shows that VP correlates with overall improvement in pain scores, opiate use and mobility in the sample group with VCF aged ≤12 weeks. Hopefully the results of this study will encourage physicians to consider vertebroplasty as a method of achieving adequate analgesia in this demographic of patients.
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cohen LD. Fractures of the osteoporotic spine. Orthop Clin North Am. 1990 Jan;21(1):143-50. PMID: 2404233.
2) Nevitt MC, Ettinger B, Black DM et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001. PMID: 9599190.
3) Deramond H, Depriester C, Toussaint P, Galibert P. Percutaneous Vertebroplasty. Semin Musculoskelet Radiol. 1997;1(2):285-296. doi: 10.1055/s-2008-1080150. PMID: 11387078.
4) Yamato M, Nishimura G, Kuramochi E, et al. (1998) MR appearance at different ages of osteoporotic compression fractures of the vertebrae. Radiat Med 16:329-334. PMID: 9862153.
5) Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004 Jan 1;69(1):111-6. PMID: 14727827.
6) Goldstein CL, Chutkan NB, Choma TJ, Orr RD. Management of the Elderly With Vertebral Compression Fractures. Neurosurgery. 2015 Oct;77 Suppl 4:S33-45. doi: 10.1227/NEU.0000000000000947. PMID: 26378356.
7) Doyle. A, Hawkins. S, Tran. J (2004). Percutaneous vertebroplasty for osteoporotic fracture: Preliminary experience at Middlemore Hospital. N Z Med J. 117. U1101.
8) Manchikanti L, Sanapati J, Pampati V et al. Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post2009 Trials. Curr Pain Headache Rep. 2020 Apr 14;24(5):22. doi: 10.1007/s11916-020-00850-2. PMID: 32291587.
9) Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563. Erratum in: N Engl J Med. 2012 Mar 8;366(10):970. PMID: 19657122; PMCID: PMC2930487.
10) Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429. PMID: 19657121.
11) Rabei R, Patel K, Ginsburg M et al. Percutaneous Vertebral Augmentation for Vertebral Compression Fractures: National Trends in the Medicare Population (2005-2015). Spine (Phila Pa 1976). 2019 Jan 15;44(2):123-133. doi: 10.1097/BRS.0000000000002893. PMID: 30562331.
12) Manchikanti L, Senapathi SHV, Milburn JM, et al. Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018. Pain Physician. 2021 Sep;24(6):401-415. PMID: 34554681.
13) Clark W, Bird P, Gonski P et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebocontrolled trial. Lancet. 2016 Oct 1;388(10052):1408-1416. doi: 10.1016/S01406736(16)31341-1. Epub 2016 Aug 17. Erratum in: Lancet. 2017 Feb 11;389(10069):602. PMID: 27544377.
14) Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011 May;14(5):561-9. doi: 10.3171/2010.12.SPINE10286. Epub 2011 Mar 4. PMID: 21375382.
15) Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9. PMID: 20701962.
16) Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3. Update in: Cochrane Database Syst Rev. 2018 Nov 06;11:CD006349. PMID: 29618171; PMCID: PMC6494647.
17) Clark W, Bird P, Diamond T, et al. Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ Evidence-Based Medicine. 2019;25(3):85-89.
18) Yang E-Z , Xu J-G, Huang G-Z et al. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila PA 1976) 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.
19) Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551. doi: 10.1136/bmj.k1551. Erratum in: BMJ. 2018 Jul 4;362:k2937. Smeet AJ [corrected to Smeets AJ]. PMID: 29743284; PMCID: PMC5941218.
20) Lau E, Ong K, Kurtz S et al. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86. doi: 10.2106/JBJS.G.00675. PMID: 18594096.
21) Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097/BRS.0000000000000992. PMID: 26020845.
22) Ong KL, Beall DP, Frohbergh M, et al. Were VCF patients at higher risk of mortality following the 2009 publication of the vertebroplasty "sham" trials? Osteoporos Int. 2018 Feb;29(2):375-383. doi: 10.1007/s00198-017-4281-z. Epub 2017 Oct 24. PMID: 29063215; PMCID: PMC6394540.
23) Hirsch JA, Chandra RV, Carter NS, et al. Number Needed to Treat with Vertebral Augmentation to Save a Life. AJNR Am J Neuroradiol. 2020 Jan;41(1):178-182. doi: 10.3174/ajnr.A6367. Epub 2019 Dec 19. PMID: 31857326; PMCID: PMC6975314.
24) Brown P, McNeill R, Leung W, et al. Current and future economic burden of osteoporosis in New Zealand. Appl Health Econ Health Policy. 2011 Mar 1;9(2):11.
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Percutaneous vertebroplasty: efficacy in the management of pain related to acute vertebral compression fractures
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As New Zealand’s ageing population grows, the prevalence of osteoporosis and related complications grow with it. Vertebral body compression fractures (VCF) are the most common osteoporotic fracture, occurring in 20% of people over the age of 70 years.[[1]] VCFs generally present with significant pain and loss of mobility. They are diagnosed by correlating clinical history and examination with imaging. Radiographic findings on X-ray, computed tomography (CT) and magnetic resonance imaging (MRI) include loss of vertebral body height, high density suggestive of bone compression, and sometimes overt fractures. A decrease in vertebral height of 20% or more, or a decrease of at least 4mm compared with baseline height is considered positive for compression fracture.[[2]]
To determine if a fracture is acute or chronic, clinical history is correlated with imaging. Evidence of acute fracture includes cortical breaking or impaction of trabeculae. The absence of these signs indicates a chronic fracture. MRI characteristically demonstrates oedema in acute fractures with a high bone marrow signal on short-TI inversion recovery (STIR) weighted scans, and MRI can help determine the age of a fracture. Isotope bone scans can also differentiate between acute and chronic compression fractures, as acute fractures will appear “hot” with increased radio-isotope up-take.[[3,4]]
As pain is the hallmark feature of VCF, analgesia is paramount in management.[[5]] Elderly patients, who are more predisposed to developing acute VCFs, are at greater risk of developing adverse effects of analgesia such as constipation, falls and nausea.[[6]] They are also at high risk of becoming deconditioned due to a prolonged period of limited mobility and are prone to developing secondary conditions such as bed sores and pneumonia.
Standard practice has been to manage a VCF with oral analgesia, and perform percutaneous vertebroplasty or kyphoplasty (“vertebral augmentation”, or VA) if there has been no improvement in pain. Percutaneous vertebroplasty is a minimally invasive procedure in which radio-opaque cement (polymethyl methacrylate- PMMA) is injected into the affected vertebral bodies under fluoroscopic guidance.[[3]] This in turn leads to stabilisation of the fracture and provides effective pain relief.
This retrospective single-centre study was undertaken to investigate the efficacy of vertebroplasty as performed at Middlemore Hospital. This is specifically in patients who had one or more acute vertebral compression fractures, all aged 12 weeks or less and positive for acute fracture-oedema on MRI. By doing this, the study was able to isolate the group thought to better respond to vertebroplasty as a means of analgesia. We hypothesised that there would be an improvement in pain scores in those that had received the procedure.
Aim
To determine if percutaneous vertebroplasty is effective in managing pain in patients with acute vertebral body compression fractures.
Method
Design: retrospective study
Setting
Fifteen consecutive patients underwent percutaneous vertebroplasty for the treatment of one or more acute vertebral insufficiency fractures at Middlemore Hospital, Counties Manukau District Health Board (CMDHB), Auckland between 2018 and 2021. All 15 patients in the cohort had a fracture age of 12 weeks or less, with the presence of increased bone marrow signal on MRI.
Prior to collating data for the study, approval was gained from the Auckland Health Research Ethics Committee (reference number: AH23296).
Participants were contacted over the phone and consented to participate in the study. They were surveyed with a questionnaire, which covered pain scores (based on the numeric pain rating scale), amount of analgesia used, and mobility pre- and post-procedure.
A secondary wing of the study analysed doses of opioid analgesia consumed prior to and following the procedure, according to outpatient medicine dispensing records. Community dispensing records were obtained to analyse the doses of opioids dispensed to look for trends in use of analgesia pre- and post-procedure.
Participants
Of the fifteen patients in the initial group, four patients were deceased, two were not contactable, and one declined to participate in the survey, resulting in eight out of fifteen that participated in the survey element.
Results
View Figures 1–6.
The illustrative vignette below demonstrates clinical history and imaging used in the process of selection, post procedure imaging and clinical outcome.
An elderly female presented with acute lumbar spine pain following a fall. She experienced severe pain requiring opiates and could not mobilise during a week-long admission. MRI confirmed the suspicious fracture of L3 but also the plain film and CT occult fracture of L4.
Figures 2–6
After two-level vertebroplasty the patient had immediate pain relief was able to mobilise and was discharged the following day on simple analgesia.
Of the eight patients in our study that participated in the survey, six patients described improvement in pain scores immediately after the procedure. Of the six, all reported either improvement or consistently similar improved pain levels 2 weeks and 1 month following the procedure. One patient reported improvement after 2 weeks, while one reported no improvement at all in pain levels following the procedure.
The average pain score among the participants preceding the procedure was 9.25/10. The average pain score immediately following the procedure was 4.375/10. The average pain scores at 2 weeks and 1 month were 3.75/10 and 2.25/10 respectively.
Of the eight participants surveyed, six felt they had improved mobility following the percutaneous vertebroplasty procedure, and two felt no improvement in mobility.
Of the four deceased (all causes not pertaining to the procedure itself), clinical notes/letters identified improvement in pain levels in all four, though not quantified as a pain score.
There were no procedure-related complications in any patient.
Of the fifteen patients, ten showed decreased amounts or complete cessation of opioid analgesia dispensed within the course of 4 weeks. Four patients had an increased dose of opiates following the initial fracture, which stayed the same post procedure. Interestingly, the one patient that reported no improvement in pain scores post procedure had decreased prescription of opiate analgesia in the community.
Discussion
Percutaneous vertebroplasty is a modality of treatment that was first reported to be successful over forty years ago.[[3]] When the procedure was initially introduced at Middlemore Hospital, CMDHB, Auckland (the same hospital where this study was conducted), there was generally very good utilisation. An early study there in 2004 describes five patients with MRI evidence of acute VCF treated over a 10-month period. This small series showed good response, with near immediate improvement in pain scores for most, and delayed improvement (over the course of 6 months) in some.[[7]] One of the authors (SPH) noted the rapid uptake of the procedure over the years up to 2009, averaging around 10 cases per year for this 800-bed tertiary care public hospital.
Utilisation of vertebroplasty—a brief overview of the timeline
In the period 2004 to 2009 there was a 188% increase in VA procedures in the USA.[[8]] As the procedure became more studied, there was more controversy surrounding the efficacy of vertebroplasty.
Randomised control trials (RCTs) comparing vertebroplasty with sham procedures/placebo reported that the procedure was not effective, and not more efficacious than placebo.[[9,10]] The most widely discussed article was published in The New England Journal of Medicine (NEJM) in 2009 by Buchbinder et al.[[10]] In 2015, procedure utilisation was studied in the Medicare population in the United States. The studied population reported a 15.6% decline in volume of VA. VA includes VP and the similar procedure of percutaneous kyphoplasty, which involves an attempt to restore spinal alignment by using devices, such as balloons, to raise vertebral body height, then using cement. From a peak in 2008, after the NEJM pub¬lication there was a persistent decline in VA procedures up to 2018 with vertebroplasty episodes in the Medicare population falling up to 66% and VA inflation-adjusted expenditure falling 40%.[[11,12]]
There have been concerns about selection criteria allowing chronic fractures into these RCTs. Since 2009, other RCTs have been carried out to study the efficacy of vertebroplasty in acute VCF, and reported treatment as superior to placebo.[[13–15]] A multicentre randomised double-blind placebo controlled trial (VAPOUR) was conducted by Clarke et al. in 2015. The study hypothesised that early intervention by vertebroplasty is key to the management of the VCF. The VAPOUR trial had a very strict inclusion criteria of less than 6 weeks fracture age with an average fracture age of 2.8 weeks. The trial demonstrated statistically more effective analgesia in the treatment group. There was also a decrease in the length of hospital stay by 6 days and a significant decrease in the Roland Morris Disability score.[[13]]
A 2018 Cochrane meta-analysis of all vertebroplasty RCTs concluded that vertebroplasty is not more efficacious in the management of the VCF.[[16]]
Dr William Clark, the primary investigator in the VAPOUR trial, eloquently described the drawbacks of the Cochrane metanalysis in an article published in The British Medical Journal (BMJ).[[17]] Trials that showed overall better outcomes in the test groups had a strict inclusion criteria of acute compression fractures. Referenced in this response, were the VAPOUR trial (mean fracture age 2.8 weeks); the Yang et al. trial (mean fracture age 1.1 weeks),[[18]] both of which showed better outcomes in the treatment group. The other trials referenced, in contrast, include VERTOS IV (mean fracture duration 6.1 weeks),[[19]] Buchbinder et al. (12 weeks),[[10]] Kallmes et al. (23 weeks),[[9]] which all had an older mean fracture age, and showed no significant improvement in analgesia between test and sham groups. Fracture age plays a critical role in the effectiveness of the vertebroplasty procedure.
Comparison of this study with others
The study, like the VAPOUR trial recruited only inpatients, with unmanageable pain requiring hospitalisation. This is unlike the VERTOS IV and Kallmes et al. trials which only recruited outpatients. Due to the comparatively strict inclusion criteria, this study only observed analgesic effect in the setting of an acute VCF. This is unlike some of the aforementioned studies which allowed for older, more chronic fractures to be included.
Strengths and limitations of this study
This study, like the VAPOUR trial, attempts to study the efficacy of vertebroplasty in the acute setting, i.e., fracture age of 12 weeks or less. However, the study design has limitations. These are the sample size and bias associated with retrospective analysis, together with recall bias. Some of the patients have also had further injuries and health issues after their procedures which resulted in requirement of analgesia. However, there was a consistent recollection of a pain-free period post procedure in those that reported improvement. There were good participation rates particularly given the length of time since the index procedure. Of the nine patients that were contacted, eight agreed to be surveyed.
Main findings of this study
Of those patients surveyed in our study, 75% showed immediate and sustained improvement in pain and mobility of which further improved over time. The average pain score of those surveyed halved from 9.25 to 4.375 immediately after the procedure. Similar reports of immediate improvement have anecdotally been described by others.[[7]] The results of this study indicate that VP is a relatively reliable, safe and acceptable means of providing analgesia in acute VCFs that would not as easily be managed with pharmacologic therapy, mainly using opioids.
Implications for practice
VCFs are associated with mortality risk. From the first VCF, 3-year mortality has been found to be 46.1%, significantly higher and around double that of matched control groups, with similar and consistent findings at 5 years and 7 years post VCF, regardless of age or sex.[[20]]
A review of the 100% USA Medicare data set 2005–2009 found that the non-VA group had a 55% higher adjusted risk of mortality than the balloon kyphoplasty and 25% higher than the vertebroplasty treated groups. This non-operated group had higher risks of pneumonia, myocardial infarction, deep vein thrombosis and urinary tract infection.[[21]]
Changes in treatment patterns and outcomes of VCF before and following the 2009 sham trials have also been studied using US Medicare data. Overall, the propensity adjusted mortality of VCF increased by 4% after 2009. The 10-year mortality risk following VCF was 19% lower in the balloon kyphoplasty group, and 7% lower in the vertebroplasty group compared with the non-operative group.[[22]] Furthermore, in a highly clinically useful approach it has been estimated from this data that the VCF number needed to treat to “save a life” may be as low as 11.9.[[23]] There are theoretical benefits of balloon kyphoplasty versus vertebroplasty but these have not been adequately studied. Patient selection and suitability criteria as well as operator bias are likely to favour younger, fitter patients being offered balloon kyphoplasty.
With an ageing population, VCFs will rise in number. A 2007 analysis of the economic burden of osteoporosis in New Zealand documented 27,994 VCFs, with $NZD 212 million spent on treating fractures, and $NZD 85 million for care after fractures. A significant proportion of those costs were attributed to hospitalisation.[[24]] Costing obtained from Middlemore Hospital showed that a single night in a rehabilitation ward costs just over $2,600 per night (with most patients requiring over a week as inpatients to manage their pain). An MRI of the thoracolumbar spine costs $1,854 and the vertebroplasty procedure costs $2,596. The data from this study points to an immediate improvement in pain levels and mobility for these patients through percutaneous vertebroplasty, targeted to the acute period post fracture where MRI confirms the acute bone marrow oedema and thereby accurately identifies the vertebral level(s) to target. The VAPOUR trial points toward an overall reduction in hospital stay and a decrease in the economic and resource burden of each fracture event.[[9]]
Future directions
This paper will hopefully draw the attention of physicians caring for patients with VCFs to the weaknesses in the earlier sham trials that have reduced the utilisation of VA worldwide, and to reaffirm that VCF is not simply a benign condition requiring analgesia. VCF is strongly associated with mortality and carries a high economic burden. Suitable patients with fracture oedema demonstrated on MRI, treated within 12 weeks, and preferably earlier, by percutaneous VA are likely to respond rapidly, reliably and with a high safety margin, reducing morbidity, mortality and healthcare costs. Clinical care pathways should incorporate appropriate investigation and consideration of these patients for VA treatment.
Summary
Abstract
Aim
Historically, both acute and chronic vertebral compression fractures (VCF) have been managed with vertebral augmentation procedures such as percutaneous vertebroplasty (VP). Recently, however, the trend has shifted to manage VCF pharmacotherapeutically. This study aims to determine if VP is effective for managing pain related to acute VCF (≤12 weeks).
Method
This study retrospectively surveyed 8 of 15 patients that underwent VP at Middlemore Hospital between 2018 and 2021. All had VCF aged ≤12 weeks, and presence of increased bone marrow signal on magnetic resonance imaging (MRI). The survey reviewed pain levels (via numeric score), opiate analgesia dispensation, and mobility levels pre- and post-procedure.
Results
Results showed post-procedure improvement in pain levels in 75% of individuals, which were maintained over the two- and four-week marks. There was an improvement in mobility in 75% of patients at 4 weeks, and 66% had decreased dispensation or complete cessation of opioid analgesia 4 weeks post procedure.
Conclusion
This study shows that VP correlates with overall improvement in pain scores, opiate use and mobility in the sample group with VCF aged ≤12 weeks. Hopefully the results of this study will encourage physicians to consider vertebroplasty as a method of achieving adequate analgesia in this demographic of patients.
Author Information
Acknowledgements
Correspondence
Correspondence Email
Competing Interests
1) Cohen LD. Fractures of the osteoporotic spine. Orthop Clin North Am. 1990 Jan;21(1):143-50. PMID: 2404233.
2) Nevitt MC, Ettinger B, Black DM et al. The association of radiographically detected vertebral fractures with back pain and function: a prospective study. Ann Intern Med. 1998 May 15;128(10):793-800. doi: 10.7326/0003-4819-128-10-199805150-00001. PMID: 9599190.
3) Deramond H, Depriester C, Toussaint P, Galibert P. Percutaneous Vertebroplasty. Semin Musculoskelet Radiol. 1997;1(2):285-296. doi: 10.1055/s-2008-1080150. PMID: 11387078.
4) Yamato M, Nishimura G, Kuramochi E, et al. (1998) MR appearance at different ages of osteoporotic compression fractures of the vertebrae. Radiat Med 16:329-334. PMID: 9862153.
5) Old JL, Calvert M. Vertebral compression fractures in the elderly. Am Fam Physician. 2004 Jan 1;69(1):111-6. PMID: 14727827.
6) Goldstein CL, Chutkan NB, Choma TJ, Orr RD. Management of the Elderly With Vertebral Compression Fractures. Neurosurgery. 2015 Oct;77 Suppl 4:S33-45. doi: 10.1227/NEU.0000000000000947. PMID: 26378356.
7) Doyle. A, Hawkins. S, Tran. J (2004). Percutaneous vertebroplasty for osteoporotic fracture: Preliminary experience at Middlemore Hospital. N Z Med J. 117. U1101.
8) Manchikanti L, Sanapati J, Pampati V et al. Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post2009 Trials. Curr Pain Headache Rep. 2020 Apr 14;24(5):22. doi: 10.1007/s11916-020-00850-2. PMID: 32291587.
9) Kallmes DF, Comstock BA, Heagerty PJ et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563. Erratum in: N Engl J Med. 2012 Mar 8;366(10):970. PMID: 19657122; PMCID: PMC2930487.
10) Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429. PMID: 19657121.
11) Rabei R, Patel K, Ginsburg M et al. Percutaneous Vertebral Augmentation for Vertebral Compression Fractures: National Trends in the Medicare Population (2005-2015). Spine (Phila Pa 1976). 2019 Jan 15;44(2):123-133. doi: 10.1097/BRS.0000000000002893. PMID: 30562331.
12) Manchikanti L, Senapathi SHV, Milburn JM, et al. Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018. Pain Physician. 2021 Sep;24(6):401-415. PMID: 34554681.
13) Clark W, Bird P, Gonski P et al. Safety and efficacy of vertebroplasty for acute painful osteoporotic fractures (VAPOUR): a multicentre, randomised, double-blind, placebocontrolled trial. Lancet. 2016 Oct 1;388(10052):1408-1416. doi: 10.1016/S01406736(16)31341-1. Epub 2016 Aug 17. Erratum in: Lancet. 2017 Feb 11;389(10069):602. PMID: 27544377.
14) Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011 May;14(5):561-9. doi: 10.3171/2010.12.SPINE10286. Epub 2011 Mar 4. PMID: 21375382.
15) Klazen CA, Lohle PN, de Vries J et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9. PMID: 20701962.
16) Buchbinder R, Johnston RV, Rischin KJ, et al. Percutaneous vertebroplasty for osteoporotic vertebral compression fracture. Cochrane Database Syst Rev. 2018 Apr 4;4(4):CD006349. doi: 10.1002/14651858.CD006349.pub3. Update in: Cochrane Database Syst Rev. 2018 Nov 06;11:CD006349. PMID: 29618171; PMCID: PMC6494647.
17) Clark W, Bird P, Diamond T, et al. Cochrane vertebroplasty review misrepresented evidence for vertebroplasty with early intervention in severely affected patients. BMJ Evidence-Based Medicine. 2019;25(3):85-89.
18) Yang E-Z , Xu J-G, Huang G-Z et al. Percutaneous Vertebroplasty Versus Conservative Treatment in Aged Patients With Acute Osteoporotic Vertebral Compression Fractures: A Prospective Randomized Controlled Clinical Study. Spine (Phila PA 1976) 2016 Apr;41(8):653-60. doi: 10.1097/BRS.0000000000001298.
19) Firanescu CE, de Vries J, Lodder P, et al. Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial. BMJ. 2018 May 9;361:k1551. doi: 10.1136/bmj.k1551. Erratum in: BMJ. 2018 Jul 4;362:k2937. Smeet AJ [corrected to Smeets AJ]. PMID: 29743284; PMCID: PMC5941218.
20) Lau E, Ong K, Kurtz S et al. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86. doi: 10.2106/JBJS.G.00675. PMID: 18594096.
21) Edidin AA, Ong KL, Lau E, Kurtz SM. Morbidity and Mortality After Vertebral Fractures: Comparison of Vertebral Augmentation and Nonoperative Management in the Medicare Population. Spine (Phila Pa 1976). 2015 Aug 1;40(15):1228-41. doi: 10.1097/BRS.0000000000000992. PMID: 26020845.
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Percutaneous vertebroplasty: efficacy in the management of pain related to acute vertebral compression fractures
As New Zealand’s ageing population grows, the prevalence of osteoporosis and related complications grow with it. Vertebral body compression fractures (VCF) are the most common osteoporotic fracture, occurring in 20% of people over the age of 70 years.
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