Evidence-Based Recommendations for Spine Surgery

A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. Buchbinder R, Osborne R, Ebeling P, et al. N Engl J Med 2009;361:557–68. Osteoporotic vertebral body compression fractures (VCFs) are extremely common among older individuals and are associated with significant axial pain and disability. The vast majority of these injuries will resolve over time with noninvasive measures, including pain control, bed rest, and brace immobilization. However, frail patients or those with significant medical comorbidities may develop adverse health effects during convalescence and others may experience persistent symptoms that ultimately prove to be refractory to these types of methods. In these instances, cement augmentation procedures, such as vertebroplasty and kyphoplasty have gained widespread acceptance as treatments for VCF, which may not only bring about significant pain relief but also facilitate functional recovery. A number of prospective studies have advocated vertebroplasty to be a safe and effective strategy for addressing VCF, which may give rise to improved early outcomes relative to conservative care1–4; these favorable results were also corroborated by a recent meta-analysis, which concluded that there is evidence suggesting that vertebroplasty may be superior to medical management for these injuries, at least in the short term.5 Although these reports characterized the potential advantages of vertebroplasty, all of these investigations were subject to certain methodologic flaws common in surgical trials, including the lack of blinding and placebo controls. In an attempt to overcome these inadequacies, Buchbinder et al performed a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial involving a series of patients who underwent either vertebroplasty or a sham intervention in an attempt to further elucidate the benefits of this technique during the first 6 months of follow-up.6 Study Summary Subjects with <12 months of axial pain secondary to 1 or 2 painful osteoporotic VCF confirmed by magnetic resonance imaging (MRI) were randomly assigned to undergo either vertebroplasty or a similar procedure without the use of cement. At the completion of the study, both treatment arms exhibited considerable reductions in overall pain. Nevertheless, vertebroplasty did not give rise to any significant advantages in any of the measured outcomes at any of the time points up to 6 months after treatment; similar improvements were reported by both groups in terms of pain scores, physical functioning, quality of life, and subjective assessments. There were also no differences between the relative incidences of subsequent fractures during the follow-up period. The authors concluded that vertebroplasty did not confer any obvious benefits compared with a simulated intervention, thereby calling into question the value of this therapy. Methodologic Review Although this is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial, there are some striking limitations to the experimental design, which significantly downgrade the impact of the study. The majority of the problems revolve around the inclusion and exclusion criteria and recruitment issues frequently encountered in surgical randomized clinical trials. For instance, this investigation included patients with up to 1 year of pain; however, the majority of VCF would be expected to heal within several months; so, the efficacy of vertebroplasty is likely diminished for individuals whose fractures may have begun to consolidate or whose pain may be coming from another source. Over 60% of patients had experienced pain for >6 weeks before the intervention, and there is insufficient data regarding the degree of fracture union; so, it is difficult to determine whether these authors examined the efficacy of vertebroplasty for treating acute fractures or simply assessed its utility for alleviating persistent pain in united fractures. Furthermore, clinical findings, such as tenderness to palpation over the spinal column, may be indicative of a fracture that has not fully resolved but the role of physical examination was not clearly elucidated in the protocol. Although MRI may certainly provide important information about the status of VCF, its diagnostic accuracy for establishing the age of these injuries is still a matter of considerable debate; so, it is unclear whether all of these fractures were all actually “acute.” Of the 219 individuals who were found to be eligible to participate in this investigation, only 78 (36%) were enrolled and underwent randomization, which raises concerns regarding a selection bias and its overall generalizability. Given the relatively low rate of enrollment, it is conceivable that patients with partially healed VCF who were in less pain may have been more willing to enter these investigations, which could have reduced the therapeutic effect of vertebroplasty observed in this analysis. Furthermore, only 71 subjects were successfully followed up until the 6-month time point, which is not necessarily a large sample for comparison. All patients in the study were accounted for during follow-up; however, there was no specific mention of the number of patients who crossed over from 1 group to the other. The most concerning issue is that the authors did not report any data for the eligible patients who declined to participate, which is an essential safeguard for any randomized, controlled clinical trial. This information may have shed some light on any type of selection or volunteer biases that may have occurred. Another controversial point is related to the considerable ambiguity regarding the etiology of low back pain. Although billed as a “sham” procedure, the injection of local anesthetic in close proximity to the zygoapophyseal joints may serve to reduce back pain secondary to facet arthritis, which could have also contributed to the equivalent results exhibited by the 2 treatment arms. Furthermore, the trial compares sham procedure with vertebroplasty but does not assess the natural history of these fractures; conversely, considering a sham treatment and natural history to be one and the same which would certainly contravene the theory behind a placebo response. Finally, 1 last concern is the authors' handling of the primary outcome measure, which was the amount of pain relief present 3 months after the procedure. Sample size calculations were performed before the study, which was initially designed to detect a change of 2.5 on a 10-point scale. However, with these types of scoring instruments, it has been suggested that the minimally clinically important difference is actually 1.57; as such, this analysis may not have been adequately powered to distinguish small but still important differences between the 2 cohorts. The effect size observed in this study was very small at 3 months (2.6 visual analog scale [VAS[score improvement in the vertebroplasty patients and 1.9 for the control group) compared with that observed by Wardlaw et al8 (4.1 with kyphoplasty and 2.3 for nonoperative therapies) or Rousing et al9 (6-point improvement in both the vertebroplasty and control cohorts). This discrepancy may largely be attributed to the disparate patient samples and the age of the fracture at the time of enrollment. The duration of symptoms in the Rousing study was <2 weeks in 80% of patients; in contrast, in the Wardlaw study, the mean age of the fracture was estimated to be 6 weeks whereas 68% of patients in the Buchbinder investigation complained of pain that had lasted anywhere from 6 weeks to 1 year. As suggested by the favorable outcomes of the control group in the Rousing article, we can conclude that when left alone, patients with VCF will almost certainly exhibit improvements in their VAS scores. If patients are enrolled after a longer duration of symptoms they will have less opportunity to develop any further improvements in their VAS score after the intervention. Recommendation on Impact to Clinical Practice Despite its significant shortcomings, this multicenter, prospective, randomized, double-blind, placebo-controlled clinical trial still offers a higher degree of evidence regarding the treatment of osteoporotic VCF with vertebroplasty although it does not provide level 1 data. Although Buchbinder et al have certainly cast some doubts about the efficacy of this technique for the particular patient groups included in their study, these findings are not generalizable to all VCF. Therefore, we conclude that there is not sufficient justification to completely abandon vertebroplasty as a method for addressing osteoporotic VCF. We believe that there is now a weak recommendation for incorporating these results into clinical practice such that it seems as if certain individuals will not benefit from vertebroplasty but others may still be appropriate candidates based on personal preference, surgeon experience, and the best available literature. A randomized trial of vertebroplasty for osteoporotic spinal fractures. Kallmes D, Comstock B, Heagerty P, et al. N Engl J Med 2009;361:569–79. Vertebroplasty is an intervention that is intended to alleviate the pain associated with VCFs and enhance the functional recovery of these patients. Although the value of this technique for osteoporotic VCF has been preliminarily established by multiple case series, a number of observational and cohort studies, as well as a randomized, controlled clinical trial, there continues to be a paucity of high-quality evidence supporting the use of vertebroplasty for this application.1–4 Certainly, the relatively favorable natural history of these injuries underscores the need to use a control group to more accurately characterize the efficacy of this intervention.10 Similar to Buchbinder et al6 who recently evaluated the short-term effects of vertebroplasty, Kallmes et al11 also published the interim results of a multicenter, prospective, randomized, blinded, placebo-controlled clinical trial comparing vertebroplasty with a sham procedure as part of the Investigational Vertebroplasty Safety and Efficacy Trial. Study Summary In this study, subjects with 1 to 3 painful osteoporotic VCF were randomly assigned to treatment consisting either of vertebroplasty or a simulated injection without cement. At 1 month, several different outcome measures were assessed to quantify any improvements in the pain and disability related to their fractures. Of note, participants were permitted to cross-over to the other cohort after 1 month. Although there was a trend toward more clinically meaningful pain relief among vertebroplasty patients, there were no significant differences between any of the clinical scores of the 2 groups at the time Nevertheless, the rate was significantly higher for individuals who had the sham procedure compared with those with Methodologic Review A calculations were performed and after recruitment were encountered to that this study was powered to the primary this investigation of the same methodologic as the Buchbinder et al investigation, such as the inclusion of patients with up to 1 year of symptoms and subjects that for pain However, the most was a very low rate of enrollment, which to the exclusion of a large number of appropriate In the authors individuals to potential subjects but only of were actually enrolled into the study, which one a selection bias that the results observed in the analysis. If the authors had the clinical of the eligible patients who did not to participate, the degree of selection bias could have been For it is conceivable that the group exhibited different of pain or that may have been either more or less likely to to This cohort the majority of subjects who were for this so, can any regarding VCF be established from the the of physical examination findings, such as the or of pain on palpation over the is also not in their protocol. the “sham” treatment that was performed also the injection of local anesthetic into the which certainly could have rise to therapeutic and the benefits of from subject to the lack of regarding the of an with this the to either a MRI or for the of the age of the fractures was left to the of the Buchbinder et these authors did not use to the age of the which is clearly a of this study the pain from these types of injuries over Recommendation on Impact to Clinical Practice Although Kallmes et al a number of concerns about the efficacy of cement augmentation as a method for treating osteoporotic VCF, we believe that the findings of this investigation not their that the clinical outcomes after vertebroplasty are equivalent to that of a sham controlled clinical in are extremely on and these be for this Although this study level 1 data based on its methodologic design, its limitations that its results be to level 2 clinical be on a scale with more patients to the of this and the of until this data we that a weak recommendation to to clinical practice is for a randomized controlled trial. R, et al. are some of the most common encountered by Although they a favorable without surgical intervention, a of patients will surgical for and have first report in and all available surgical case reports in a procedure with and of the that surgical has been on that have reduce and published the use of the for in Although initially with this technique has a technique for in the treatment of and series have surgical to be in the of to In and the technique of incorporating a technique that was expected to reduce reduce and recovery without Although there have been randomized controlled comparing with this study the first multicenter, randomized trial outcome and recovery time for patients one of these Study Summary This randomized controlled trial was performed at in the from to and patients to who had persistent pain of were included in the study. and subjects were randomized to and were randomized to Although patients in both groups improvement in all measures with this study that outcomes were for scores for were not significantly different in over the follow-up however, at the time point, scores were for the group the group Over the follow-up VAS scores for pain were significantly for the group but at the time point, they were not different VAS score for back pain over the study was in the group but not different at the time point Finally, although more patients in the group a recovery at the for time until recovery results for weeks for The authors that and were between the 2 as were of to and of compared with did not in a significant improvement in the in results for patient back and recovery. The authors concluded that there is no difference in scores in patients who compared with Methodologic Review et al be for a and between and In this is a between 2 different surgical designed to the same but have different clinical results of less with the The authors have to the difficult issue of in surgical by multiple and on the We based on and preference, that not all or in the same the relative benefits of technique will by The authors that their these in practice into their data. For these authors a in all of their but one in only of their in of and no visual at all in the to more in the group the not significant all to of the study This is a the and sample size calculations were performed to a We or of 1 technique the other. time for was significantly longer report a rate of for and for All findings but may be by surgeon although all were with both The authors have a in and this trial. a of subject their was very well appropriate were and they clearly the limitations of the study. Recommendation on Impact to Clinical Practice The technique on its which the degree of by a does not to confer significant benefit in terms of functional recovery or back and pain at 1 year after in the of a Although this study is its not be to more including or For the patient included in this study, secondary to a recommendation to these findings into clinical practice be the technique is not superior and not be if or adverse the If these are the clinical experience of the surgeon to some patient the procedure A prospective, cohort study comparing with and for of the D, D, et al. J have over the last to effect and enhance when clinically The has over the last a vast of is essential that use this and clinical with issues and further that we the clinical efficacy of has the method for establishing in terms of and facet was by et in as an for This technique has been evaluated in the and has been to have a rate and it has been in to be equivalent to in all Certainly, as minimally facet may be to the other there are a number of limitations to facet For the for this intervention are more both clinically and this procedure has been associated with higher in further the relative of these 2 et al have a prospective study comparing with and Study Summary This prospective, observational cohort study was at a in A of subjects the inclusion in the group and in the surgeon or 2 there was no difference between the 2 groups in the mean in the of or with rate at a mean after This study for higher in the group and higher problems in the group The authors concluded that the 2 and were associated with almost patient Methodologic Review Although the authors that patients were among the the performed of and the other authors performed the patients were were to the procedure with which they more was also not to as they the patients in the group were significantly older and had significantly more comorbidities the patients in the group differences may significant bias into the study and are to differences in and of Furthermore, the comparing of the 2 groups is important such as outcome scores, or back pain and for The most with this study to the for The authors in the of on the primary although they did not provide this analysis. In a study, this same group that patients with of and patients without with In this study, however, the authors the inclusion criteria to their reported Recommendation on Impact to Clinical Practice In although et al have a prospective between facet and with the limitations in this study significantly the that they the and sample size calculations were performed to a we or as we would be a type 2 A large sample size is to prove or no to clinical practice are based on the evidence by this study. treatment and the quality of in patients with a prospective study. et al. The treatment of patients with difficult to This group of patients has significant disability but also a for studies have on Although a number of studies have a clinical impact of surgical a prospective of and nonoperative treatment has not been Study Summary The of the Study reports the results of a prospective study of patients to with who underwent or nonoperative treatment for their spinal and patients were enrolled in the follow-up data were available for of nonoperative patients and of the patients underwent nonoperative and had in with the on or outcomes were assessed including the quality of the and the scale back and pain scores. overall analysis comparing all patients in both groups was In an to the impact of selection bias in this study, score was performed to for differences between the treatment groups A clinically and significant difference between the groups in the primary the was found at the who underwent on a significant improvement in their clinical outcome measures whereas those patients who underwent nonoperative treatment did This was for both the and Methodologic Review Although a multicenter, prospective study was the methodologic limitations are very The of this study to the of the patient The inclusion criteria are and likely both and 2 different The patient selection criteria are and there is no information about the of eligible patients who were Although the patients were specific criteria for that can be in other are not and it is to patients were eligible but either were not or declined to of the enrolled patients were from of the This that between and patients were enrolled from those the other on 2 patients during the study period. further it is to this enrolled compares with the overall of with A further of the study, as the authors is that the majority of patients in the nonoperative of were to Although the and of these patients were not significantly different from the patients who were in the study that does not mean that the patients were similar in other such as their to follow-up is not in an patient study. For those nonoperative patients who in the study, the of nonoperative is not or The of physical and are not nonoperative is by the symptoms back and not these a cohort group for with surgical The of the patients in the nonoperative group and of the data can The that patients in the nonoperative group did not significantly may that is not a may also be that nonoperative treatment can the data could that the patients to follow-up had more significant either or treatment or their symptoms resolved and they for the and the clinical of the study significantly Recommendation on Impact to Clinical Practice is not to any about the relative of and nonoperative treatment for based on this study. a degree of of and nonoperative in studies of painful spinal is whether the study is randomized or Study and such as and scores, can to for differences between groups but only for among patients who in the study and who have similar to clinical practice can be based on this does method results of the Trial. et al. The study has evidence to the treatment of short and outcomes have been a benefit to surgical management over The surgical management of without of the relative of 1 technique over This analysis to the outcomes of 3 different and a of the of the Study Summary et al present an analysis of the of the In that study, patients were either followed as part of a cohort study if they in the randomized assigned to undergo or nonoperative The procedure performed for any patient was left to the The authors' was to determine whether the procedure type had a significant effect on patient outcomes at up to after assessed included measures of quality of and measures and and an of likely status by the treating surgeon based on were for differences between the treatment and were performed to determine the of differences in outcome between Of the patients observational and randomized for there were had a alone, underwent a with had a with an and had a procedure, consisting of a and an performed either a or or an At patients a procedure were and were less likely to have or Although there were some significant differences in outcomes in the early follow-up these differences were not at There was some in the of the outcome with procedure pain and physical at 2 The cohort was not at any time point for any and significant scores at 1 year after significant differences were found between groups at or All groups improvements from that were at Methodologic Review This study has several The study was not designed to for differences in outcomes between may not have sufficient to detect a small difference with Although the overall study included a randomized clinical trial patients were not randomized to specific The regarding specific surgical treatment was by the and the patient based on of and of and Furthermore, this study patients from both the observational and randomized arms. There is to be selection bias in patient such that associated with a particular procedure also be or with of selection bias is found in the differences between the treatment of and of This selection bias to determine the efficacy of however, the that surgeon and patient for a technique are a cohort is the best method to determine and enhance generalizability. follow-up may differences in As by the et reported a effect of on patient in a study. The impact of may be when the studies report to the of status is another of the study. As by the status of their patients in an with no Although a significant this clinical in patients; only with specific clinical and findings are more of status This the of the study more its generalizability. Recommendation on Impact to Clinical Practice The study the cohort and best available evidence to of patients with does its first all 3 surgical treatments in clinical improvements over health The study does not adequately the different in different of change the follow-up The study the need for further prospective, and study of different in the management of on the data in this study, all 3 have similar effects on clinical outcomes for patients with spinal and For patients with a recommendation to these findings into clinical practice be any of the 3 can be for the treatment of this which technique is is based on surgeon and patient

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