This is the current release of the guideline.

The appropriateness criteria are reviewed biennially and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

Vertebral compression fractures

To evaluate the appropriateness of management interventions for patients with vertebral compression fractures

Patients with vertebral compression fractures

Literature Search Procedure

The Medline literature search is based on keywords provided by the topic author. The two general classes of keywords are those related to the condition (e.g., ankle pain, fever) and those that describe the diagnostic or therapeutic intervention of interest (e.g., mammography, MRI).

The search terms and parameters are manipulated to produce the most relevant, current evidence to address the American College of Radiology Appropriateness Criteria (ACR AC) topic being reviewed or developed. Combining the clinical conditions and diagnostic modalities or therapeutic procedures narrows the search to be relevant to the topic. Exploding the term "diagnostic imaging" captures relevant results for diagnostic topics.

The following criteria/limits are used in the searches.

1. Articles that have abstracts available and are concerned with humans.
2. Restrict the search to the year prior to the last topic update or in some cases the author of the topic may specify which year range to use in the search. For new topics, the year range is restricted to the last 5 years unless the topic author provides other instructions.
3. May restrict the search to Adults only or Pediatrics only.
4. Articles consisting of only summaries or case reports are often excluded from final results.

The search strategy may be revised to improve the output as needed.

The total number of source documents identified as the result of the literature search is not known.

Strength of Evidence Key

Category 1 - The conclusions of the study are valid and strongly supported by study design, analysis and results.

Category 2 - The conclusions of the study are likely valid, but study design does not permit certainty.

Category 3 - The conclusions of the study may be valid but the evidence supporting the conclusions is inconclusive or equivocal.

Category 4 - The conclusions of the study may not be valid because the evidence may not be reliable given the study design or analysis.

The topic author drafts or revises the narrative text summarizing the evidence found in the literature. American College of Radiology (ACR) staff draft an evidence table based on the analysis of the selected literature. These tables rate the strength of the evidence for all articles included in the narrative text.

The expert panel reviews the narrative text, evidence table, and the supporting literature for each of the topic-variant combinations and assigns an appropriateness rating for each procedure listed in the table. Each individual panel member forms his/her own opinion based on his/her interpretation of the available evidence.

More information about the evidence table development process can be found in the ACR Appropriateness Criteria® Evidence Table Development document (see the "Availability of Companion Documents" field).

Modified Delphi Technique

The appropriateness ratings for each of the procedures included in the Appropriateness Criteria topics are determined using a modified Delphi methodology. A series of surveys are conducted to elicit each panelist's expert interpretation of the evidence, based on the available data, regarding the appropriateness of an imaging or therapeutic procedure for a specific clinical scenario. American College of Radiology (ACR) staff distributes surveys to the panelists along with the evidence table and narrative. Each panelist interprets the available evidence and rates each procedure. The surveys are completed by panelists without consulting other panelists. The ratings are a scale between 1 and 9, which is further divided into three categories: 1, 2, or 3 is defined as "usually not appropriate"; 4, 5, or 6 is defined as "may be appropriate"; and 7, 8, or 9 is defined as "usually appropriate." Each panel member assigns one rating for each procedure per survey round. The surveys are collected and the results are tabulated, de-identified and redistributed after each round. A maximum of three rounds are conducted. The modified Delphi technique enables each panelist to express individual interpretations of the evidence and his or her expert opinion without excessive bias from fellow panelists in a simple, standardized and economical process.

Consensus among the panel members must be achieved to determine the final rating for each procedure. Consensus is defined as eighty percent (80%) agreement within a rating category. The final rating is determined by the median of all the ratings once consensus has been reached. Up to three rating rounds are conducted to achieve consensus.

If consensus is not reached, the panel is convened by conference call. The strengths and weaknesses of each imaging procedure that has not reached consensus are discussed and a final rating is proposed. If the panelists on the call agree, the rating is accepted as the panel's consensus. The document is circulated to all the panelists to make the final determination. If consensus cannot be reached on the call or when the document is circulated, "No consensus" appears in the rating column and the reasons for this decision are added to the comment sections.

Not applicable

Three recent studies that directly compared vertebroplasty proper with balloon kyphoplasty showed no significant difference in outcome (based on results and complications), with the same type of complications occurring in both. Furthermore, one cost analysis demonstrated no difference in the hospital charge between the two cases.

Criteria developed by the Expert Panels are reviewed by the American College of Radiology (ACR) Committee on Appropriateness Criteria.

ACR Appropriateness Criteria®

Clinical Condition: Management of Vertebral Compression Fractures

Variant 1: 75-year-old woman with a documented old T9 compression fracture and 1- to 3-week-old painful compression fracture of T12 without history of trauma. Patient has a history of gastric ulcer-related NSAIDs 2 years ago. Patient lives alone, is active, and the new fracture is impeding her independence. The older T9 fracture healed within 4-5 weeks.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 2: 75-year-old active man with a T9 compression fracture without history of trauma. The new fracture is impeding his normal activity.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 3: 54-year-old active man with a T7 burst fracture with a history of trauma 2 weeks ago. The new fracture is impeding his activity and work. Patient also complains of new-onset right lower limb tingling.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 4: 69-year-old woman with a painful T10 compression fracture that is 10 weeks old without history of trauma. Patient was treated with NSAIDs for 8 weeks and the pain has not improved. Patient lives alone, is active, and the fracture is impeding her independence.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 5: 80-year-old woman with a documented old T9 compression fracture treated by a percutaneous vertebroplasty 4 months ago. Now complains of a 5-week-old painful compression fracture of T12 without history of trauma. Patient is chronically constipated with history of cathartic abuse. Patient lives alone, is active, and the new fracture is impeding her independence.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Variant 6: 85-year-old chronically bedridden man with a painful T10 compression fracture treated by NSAIDs for 6 weeks. Patient is chronically constipated.

Note: Abbreviations used in the tables are listed at the end of the "Major Recommendations" field.

Summary of Literature Review

Introduction

Vertebral augmentation is a term referring to percutaneous vertebroplasty and balloon-assisted kyphoplasty. They are procedures used for the palliation of pain related to vertebral compression fractures. Vertebral compression fractures can be caused by osteoporosis, direct acute trauma in otherwise healthy vertebra, and neoplasms. Neoplasms causing vertebral compression fractures include: 1) primary bone neoplasms (hemangiomas, giant cell tumors), 2) infiltrative neoplasms (multiple myeloma, lymphoma), and 3) metastatic neoplasms. Osteoporotic vertebral compression fractures are the most commonly encountered fractures requiring augmentation and will be the focus of this narrative.

Postmenopausal women represent the majority of patients at risk for developing osteoporotic fractures of any type, and vertebral compression fractures represent 25% of osteoporotic fractures. Painful vertebral compression fractures may cause a marked decline in physical activity and quality of life, leading to general physical deconditioning. This in turn may prompt further complications related to poor inspiratory effort (atelectasis and pneumonia) and venous stasis (deep venous thrombosis and pulmonary embolism). Successful management of painful vertebral compression fractures has the potential for improving quality of life, increasing expectancy of independent and/or productive life, and preventing superimposed medical complications. Some suggest that management of painful vertebral compression fractures may also have a cost benefit to society as a whole; however, assessment of any potential societal benefits is difficult due to the inexactness of methods for quantifying pain-related disability.

Management Overview

The initial and gold standard treatment of painful vertebral compression fractures is conservative management, which includes medical management with or without methods of immobility. Most pain-related symptoms from vertebral compression fractures resolve with this management. Vertebral augmentation in the form of percutaneous vertebroplasty and, more recently, balloon-aided kyphoplasty has been used for managing painful vertebral compression fractures that are refractory to conservative management. Due to its expanded use within the medical community, the rapidity of clinical response, and the relatively low procedural risk, the threshold for performing vertebral augmentation has declined. Indeed, some authors advocate "prophylactic vertebroplasty." More invasive modifications such as "open kyphoplasty" have also been described for managing complex fractures that pose a relative contraindication for traditional vertebroplasty. The increasingly widespread clinical applications and proposed indications for vertebral augmentation have fueled debate on the utility, medical cost effectiveness, and societal cost effectiveness of these procedures.

Management Options

Conservative Management

Conservative management is the first-line and gold standard treatment of painful vertebral compression fractures. It includes medical management with or without methods of immobility. Medications used include nonsteroidal anti-inflammatory drugs (NSAIDs) and narcotics. However, these medications have complications. Gastrointestinal hemorrhage, ulcerative perforations, and death occur in 1.5% of the patients annually, with 40% of chronic users having endoscopically proven ulcers. Narcotics for noncancer pain management can lead to constipation (41%), nausea (32%), somnolence (29%), and addiction in patients with all patients, exhibiting at least one adverse effect.

Most patients with osteoporotic vertebral compression fractures, even without medication, have spontaneous resolution of pain within 4 to 6 weeks from the initial onset of pain. From the inception of vertebral augmentation in the late 1980s, its minimally invasive procedures have been reserved for patients who have failed conservative therapy. Failure can be defined as pain refractory to oral medications (NSAIDs and/or narcotics) over 6-12 weeks. However, failure can also be defined as contraindications to such medications or a requirement for parenteral narcotics and hospital admission.

Percutaneous Vertebroplasty

Percutaneous vertebroplasty has been used for managing osteoporotic vertebral compression fractures since the 1980s in Europe and the early 1990s in the United States. It involves injection of low-viscosity cement directly into the vertebral body using a unipedicle or bipedicle needles. The procedure has had significant success, with 89%-93% of patients having reduced pain and pain-related morbidity and up to 40% having complete resolution of pain. This translates to improved ambulation (up to normal activity) in 56%-95% of patients. Women and patients younger than age 75 appear to benefit the most. The ideal preprocedural imaging is somewhat controversial. Focal spinous process pain on palpation correlated with radiographs of the vertebral column is a satisfactory indication for the procedure for some authors. Alternatively, others have recommended MRI prior to the procedure. MRI, especially using a short tau inversion recovery (STIR) sequence, is sensitive for detecting acute fractures and may differentiate synchronous fractures. Minimally deforming fractures overlooked by conventional radiographs and detected on MRI may be a cause of clinical failure of vertebroplasty. The benefit of MRI must be weighed against its cost. CT is usually reserved for detailed analysis of fractures extending to the posterior column of the vertebra.

In an analysis of several studies, prevertebroplasty mean pain estimates based on a visual analogue scale (VAS scale range: 0-10) ranged from 8.1-8.4 and were reduced to 2.6-3.0 postvertebroplasty. In a similar analysis by the authors of this meta-analysis of five studies published in the last year with a sum of over 1,400 patients, the mean VAS range was reduced from 5.4-9.1 to 1.5-4.9. All studies individually had a statistically significant (P<0.05) improvement in the VAS pain scale. Although reported complications ranged from only 1% to 3.9%, they varied depending on: 1) specific definitions of complications, 2) degree of clinical and imaging follow-up, and 3) collective definitions (amalgamation) of complications. Frequently mentioned complications included: cement leak (asymptomatic or symptomatic), cement pulmonary embolism (asymptomatic or symptomatic), bleeding/hematoma, infection, and neurological deficit (transient or permanent). Delayed complications included occurrence of fractures involving other vertebral levels in 2.5%-17.3% of cases (subject to length and degree of follow-up and definitions and imaging quality) with 43%-49% and 51%-57% of these fractures occurring in distant or adjacent vertebral bodies, respectively.

Whether or not additional fractures is truly a long-term complication of the procedure (in part contributed by the procedure) or natural history and/or progression of osteoporosis is unknown and is difficult to assess without prospective randomized trials involving large numbers of subjects. Addressing the issue of additional fractures in vertebroplasty patients, one group of investigators devised a randomized controlled prospective study in a small sample size. In this study, patients were randomized to a percutaneous vertebroplasty group and a sham/placebo group. Within a 6-month follow-up, 8.6% (n=3/35) of the vertebroplasty group and 11.1% (n=4/36) of the placebo group had secondary vertebral fractures.

Recently, the results of two independent prospective randomized control studies were published comparing percutaneous vertebroplasty with a placebo control group. The total number of patients with adequate follow-up in both studies was 202 (103 in the vertebroplasty group and 99 in the control group). Both limbs in both studies had reduced pain, with a trend towards better pain control in the vertebroplasty group. However, both studies concluded that the percutaneous vertebroplasty group did not show a statistical clinical advantage over the placebo group. The Investigational Vertebroplasty Safety and Efficacy Trial (INVEST) used lidocaine injection through the transpedicular needle as its control. One of the studies did not instill any medication in the control group.

These results have stirred a debate between critics and supporters of the two studies. Criticism has focused on the scientific validity of the trials. These authors mostly criticize the relatively small sample size, the use of lidocaine in the INVEST trial, and the high cross-over from the placebo control group to the vertebroplasty group in addition to a possible superimposed placebo effect. This high cross-over may indicate a dissatisfaction of patients in the control group beyond the placebo effect, and it may be compounded by the relatively small sample sizes. An additional caveat predicted by prior authors is that patients with significant pain, and those who are most likely to respond significantly to vertebroplasty, may also be reluctant to participate in a trial with a 50% chance of undergoing a sham procedure. Supporters of the findings of these two trials mention that these are the highest-level trials investigating percutaneous vertebroplasty to date. Some authors consider using an invasive procedure (vertebroplasty) for managing pain from osteoporotic fractures with no apparent merit beyond the placebo effect as "unethical and immoral."

Balloon Kyphoplasty

Balloon kyphoplasty is a more recent variant of vertebral augmentation involving inflation of one or two intravertebral body balloons to create a void for the injection of high-viscosity bone cement. As with traditional percutaneous vertebroplasty, it can be achieved via a unipedicle (single balloon) or classically bipedicle (double balloon) approach. There is less clinical experience with balloon kyphoplasty than with conventional vertebroplasty. Three recent studies that directly compared vertebroplasty proper with balloon kyphoplasty showed no significant difference in outcome (based on results and complications), with the same type of complications occurring in both. Furthermore, a cost analysis demonstrated no difference in the hospital charge between the two cases. However, balloon kyphoplasty may have some merit for certain conditions such as vertebral burst fractures with or without neurological symptoms where it may offer a more controlled angular and fracture correction with cement deposition compared to vertebroplasty alone. In addition, some authors believe that balloon kyphoplasty is superior to conventional vertebroplasty height restoration.

Open Balloon Kyphoplasty

Open balloon kyphoplasty is the most invasive variant of vertebral augmentation. It involves using balloon kyphoplasty with a surgical component that may include laminectomy, decompression, short-segment vertebral osteosynthesis, and/or short posterior internal fixation. One group of researchers disclosed a limited experience in 16 patients with neurological symptoms where all had improved symptoms and 88% had resolution of their symptoms. Another study of 21 patients showed that pain improved up to 3 months after the procedure and then reached a plateau. This trend was also reflected by the percentage of patients who had residual disability where the percentages at 1, 3, and 12 months were 88%, 35%, and 36%, respectively. The experience with this procedure is limited and appears to be specific to trauma-related burst fractures, possibly in younger nonosteoporotic populations with neurological symptoms. However, the use of hardware is difficult in the osteoporotic population due the poor anchorage of hardware in weak osteoporotic vertebral bodies.

Summary

• Conservative management is the first-line and gold standard management.
• Recently two independent level 1 trials demonstrated no clinical validity for vertebroplasty beyond the placebo effect.
• There is an ongoing debate about the validity of vertebroplasty for managing painful osteoporotic vertebral fractures, with some vertebroplasty critics considering its use for this purpose as "unethical and immoral."
• If vertebroplasty is recommended, it probably should be used as a second-line procedure for patients who have failed or cannot tolerate conservative management.
• From the initial data, balloon kyphoplasty has similar results to the traditional variant of vertebral augmentation (percutaneous vertebroplasty proper) in uncomplicated vertebral compression fractures.
• Balloon kyphoplasty may have an advantage over traditional percutaneous vertebroplasty in complex cases (e.g., burst fractures with neurological compromise).
• A level 1 study is required for medical and societal cost analysis of the palliative effect on pain-related morbidity associated with osteoporotic vertebral compression fractures.

Abbreviations

• MRI, magnetic resonance imaging
• NSAIDs, nonsteroidal anti-inflammatory drugs

Algorithms were not developed from criteria guidelines.

The recommendations are based on analysis of the current literature and expert panel consensus.

Selection of appropriate treatment procedures for the management of vertebral compression fractures

The American College of Radiology (ACR) Committee on Appropriateness Criteria and its expert panels have developed criteria for determining appropriate imaging examinations for diagnosis and treatment of specified medical condition(s). These criteria are intended to guide radiologists, radiation oncologists, and referring physicians in making decisions regarding radiologic imaging and treatment. Generally, the complexity and severity of a patient's clinical condition should dictate the selection of appropriate imaging procedures or treatments. Only those examinations generally used for evaluation of the patient's condition are ranked. Other imaging studies necessary to evaluate other co-existent diseases or other medical consequences of this condition are not considered in this document. The availability of equipment or personnel may influence the selection of appropriate imaging procedures or treatments. Imaging techniques classified as investigational by the U.S. Food and Drug Administration (FDA) have not been considered in developing these criteria; however, study of new equipment and applications should be encouraged. The ultimate decision regarding the appropriateness of any specific radiologic examination or treatment must be made by the referring physician and radiologist in light of all the circumstances presented in an individual examination.

An implementation strategy was not provided.

Not applicable: The guideline was not adapted from another source.

The American College of Radiology (ACR) provided the funding and the resources for these ACR Appropriateness Criteria®.

Committee on Appropriateness Criteria, Expert Panel on Interventional Radiology

Panel Members: Wael E. A. Saad, MB, BCh (Principal Author); Brian S. Funaki, MD (Panel Chair); Charles E. Ray, Jr, MD (Panel Vice-Chair); Peter D. Angevine, MD, MPH; Charles T. Burke, MD; Nicholas Fidelman, MD; Ian Blair Fries, MD; Roger Hartl, MD; Langston Holly, MD; Thomas B. Kinney, MD; Jon K. Kostelic, MD; Brian E. Kouri, MD; Jonathan M. Lorenz, MD; Ajit V. Nair, MD; Albert A. Nemcek Jr, MD; Charles A. Owens, MD; George Vatakencherry, MD; Richard H. Daffner, MD; Franz J. Wippold II, MD

Not stated

This is the current release of the guideline.

The appropriateness criteria are reviewed biennially and updated by the panels as needed, depending on introduction of new and highly significant scientific evidence.

Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.

Print copies: Available from the American College of Radiology, 1891 Preston White Drive, Reston, VA 20191. Telephone: (703) 648-8900.

The following are available:

• ACR Appropriateness Criteria®. Overview. Reston (VA): American College of Radiology; 2 p. Electronic copies: Available in Portable Document Format (PDF) from the American College of Radiology (ACR) Web site.
• ACR Appropriateness Criteria®. Literature search process. Reston (VA): American College of Radiology; 1 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.
• ACR Appropriateness Criteria®. Evidence table development. Reston (VA): American College of Radiology; 4 p. Electronic copies: Available in Portable Document Format (PDF) from the ACR Web site.

None available

This NGC summary was completed by ECRI Institute on September 19, 2011.

Instructions for downloading, use, and reproduction of the American College of Radiology (ACR) Appropriateness Criteria® may be found on the ACR Web site .