Appropriate Use Criteria
Osteoporotic Compression Fracture
Discussion
This document reviewed appropriateness of treatment for osteoporotic vertebral fractures. Conclusions were drawn from a methodology designed to provide answers to clinical scenarios regarding care of osteoporotic fractures based on the existing evidence and clinical expertise from a multidisciplinary panel. Scenarios that were appropriate with agreement are probably reasonable to consider. Those that are rarely appropriate are most likely unreasonable to consider. Uncertain or disagreement ratings likely arise when the strength of the current literature is weaker and experience with the procedure has been variable. These are often scenarios in which success has been realized but results are more inconsistent and/or controversial, or the potential for harm is higher. In these cases, more scientific study is needed to clarify the direction of recommendation. This is not a declaration that these procedures are appropriate or inappropriate. Rather they can be considered but deserve more scrutiny on an individual basis. In the past, time has been used to determine onset and acuity of the fracture. More contemporary decision making includes two alternatives. If the fracture has a discrete mechanism associated with the onset of pain, and there is continued pain, and a radiograph shows compression, then acute fracture diagnosis is made regardless of the duration of pain. Secondly, if the onset of pain is unknown, then presence of edema in the bone marrow of the fractured vertebra on MRI is diagnostic of acute fracture. This definition establishes MRI and the presence of edema as a gold standard for acute vertebral fracture. If MRI cannot be done, a bone scan is a viable alternative. There are several recent publications that support this concept.208-211 There were 144 scenarios based on the modifiers. Some of the scenarios are very common in clinical practice, and the opposite is also true. As a result, when considering recommendations, it is important to look at each scenario individually as opposed to forming a conclusion based on percentage scores for a general category. Medical treatment encompasses a wide range of therapies. Segmenting each discrete therapy was beyond the scope of this project, and therefore more granular recommendations could not be made. Regardless, it is important to note that medical treatment was determined to be of value in some form for all patients with osteoporotic vertebral fractures, as this category of treatment received appropriate with agreement ratings for every scenario. Interventions such as bone density analysis, education, prevention, and pharmacologic treatment for bone health appear to be mainstays in the continuum of care for these patients. This is consistent with multiple prior studies.212-215 These recommendations are not exclusive of recommendations for cement augmentation or surgical reconstruction, and these interventions are valuable regardless of procedural indications. Cement augmentation received appropriate with agreement ratings in 5% and uncertain ratings in 35%, suggesting this is a consideration in 40% of scenarios. Scenarios with chronic fractures with lower pain scores and community ambulators were nearly always rated as rarely appropriate. Scenarios with spinal stenosis and higher levels of pain resulted in more uncertainty or disagreement amongst the raters. In the 5% of scenarios where cement augmentation was appropriate with agreement, high pain scores, acute fracture, and simple fracture patterns were always present. Presence of instability or spinal stenosis with neurologic changes were the only consistent contraindications to cement augmentation. Several recent reviews suggests that non operative treatment is often successful.96,209,211, 216-219 Thus, for those patients with less impact on pain and function, a trial of non-operative management is sensible, as they may regain their function with observation alone, and the value of procedural intervention is less certain. A Cochrane review published in 2018 concluded that vertebroplasty did not offer any benefit over non operative treatment.220 Otherwise, most recent reports suggest that there are definite improvements in pain and function following cement augmentation.48,83,211,221-229 In general, persistently high pain levels is the common primary indication for intervention which is very much aligned with the results of this study. While 60% of scenarios were rarely appropriate, this is not meant to suggest that most patients will not benefit from augmentation. For those scenarios where symptoms persist with functional impairment, there is data to suggest that augmentation will result in better clinical outcomes.230 Additionally, while complex fracture patterns and middle column fractures generated lower ratings, in certain situations cement augmentation can be done safely and effectively when needed.231 Surgery was appropriate in 35% and uncertain in 47% of cases, suggesting that surgery is an option in 82% of scenarios. Surgical intervention was more likely to be rated as appropriate with agreement in the presence of spinal stenosis with neurologic changes. Fracture stability and pain were also important in determining the final rating. Fracture morphology, physical function, and duration of the fracture were not influential in the final rating for appropriateness of surgery. It is worth noting that in clinical practice, reconstructive surgery is not nearly as common as these findings infer. This is because instability and stenosis with neurologic changes strongly influence surgical decisions but are not necessarily that common in patients with osteoporotic vertebral fractures. Reconstructive surgery can include decompression to address stenosis and neurological deficit as well as instrumentation to address stability and/or deformity.232-240 There are various strategies used in this patient population to optimize surgical outcomes. This can include cement augmentation of the fracture and/or the implants, short or long segment reconstructions, open versus minimal access or percutaneous procedures, and anterior and/or posterior approaches. The details of accomplishing the surgical goals are beyond the scope of this study, but the primary indications for surgery are generally stenosis with neurological impairment, deformity, and/or fracture instability which are consistent with the findings in this study. Appropriateness manuscripts based on the RAND methodology have been published in the past, one in 2013 and one in 2018.241,242 Neither of these studies considered surgical reconstruction as an option. Additionally, both attempted to differentiate vertebroplasty from kyphoplasty and did not consider other types of vertebral augmentation. In these studies, nonoperative treatment, vertebroplasty and kyphoplasty were generally considered exclusive of one another as well. They both found a percentage of patients that were appropriate for nonoperative treatment, but in these cases, they were referring to no procedural intervention. They did acknowledge the importance of treatment of suboptimal bone density. Although their definitions were different, there was substantial overlap with the findings of this study that all patients with vertebral compression fractures should have conservative care, if not nonoperative care. There was also some variation but significant overlap in what this study termed modifiers and the ultimate construction of the scenarios in all three studies. Since their ultimate treatment options were different, the results are not directly comparable. There was complete agreement on the importance of the definition of acute fracture and the use of MRI or appropriate substitute when MRI was contraindicated to determine appropriateness of procedural intervention. As in this study, their main drivers for cement augmentation were persistent pain and loss of function. They also placed a little more emphasis on progression of vertebral deformity. They did not specifically consider spinal stenosis or neurological deficits as a modifier. Due to the construction of their matrices, cement augmentation was appropriate or uncertain in a much higher percentage of patient scenarios than in this study. Additionally, they identified various categories of contraindications. Infection was absolute and pregnancy was strong, and then relative contraindications to allergy to fill material, coagulopathy, spinal instability, myelopathy from the fracture, neurologic deficit, and neural impingement. These criteria do not represent a “standard of care,” nor are they intended as a fixed treatment protocol. It is anticipated that there will be patients who will require less or more treatment than the average. It is also acknowledged that in atypical cases, treatment falling outside these criteria will sometimes be necessary. However, it does provide an evidence-based document to help guide decision-making. The descriptions are important. “Appropriate” does not mean a practitioner must follow a scenario but rather that it would be reasonable to consider that treatment and that benefits usually substantially outweigh harm. “Uncertainty” or “Disagreement” implies either a lack of evidence or conflicting evidence that combined with experience does not establish clear certainty for treatment for a given scenario. Lastly, “rarely appropriate” is a fairly strong declaration of opposition but does not mean that a scenario would be ill-advised in all circumstances.