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.
Treatment/Procedure |
Rating |
Comments |
Home health or skilled nursing facility with conservative (no NSAIDs) management |
7 |
|
Vertebroplasty |
6 |
After failed trial of conservative measures or if unable to tolerate conservative management. |
Kyphoplasty |
6 |
After failed trial of conservative measures or if unable to tolerate conservative management. |
Conservative management including NSAIDs |
3 |
|
Open kyphoplasty |
2 |
|
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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.
Treatment/Procedure |
Rating |
Comments |
Evaluate the cause of the fracture including MRI |
9 |
Significant information such as etiology of the fracture can be obtained from cross-sectional imaging. |
Conservative management including NSAIDs |
8 |
|
Vertebroplasty |
5 |
Underlying pathology, such as malignancy, should be ruled out. |
Kyphoplasty |
5 |
Underlying pathology, such as malignancy, should be ruled out. |
Open kyphoplasty |
1 |
|
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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.
Treatment/Procedure |
Rating |
Comments |
Evaluate the cause of the fracture including MRI |
8 |
|
Conservative management including NSAIDs |
5 |
Given neurologic complications, urgent surgical evaluation should be considered. Cross sectional imaging should be performed. |
Open kyphoplasty |
5 |
Open surgery may be appropriate. |
Vertebroplasty |
2 |
Depends on the fracture, cause of neurologic compromise, and results of the imaging workup. |
Kyphoplasty |
2 |
Depends on the fracture, cause of neurologic compromise, and results of the imaging workup. |
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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.
Treatment/Procedure |
Rating |
Comments |
Vertebroplasty |
8 |
|
Kyphoplasty |
8 |
|
Home health or skilled nursing facility with conservative (no NSAIDs) management |
3 |
Patient has already failed conservative management. |
Continue conservative management including NSAIDs |
3 |
Patient has already failed conservative management. |
Open kyphoplasty |
2 |
|
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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.
Treatment/Procedure |
Rating |
Comments |
Vertebroplasty |
8 |
Vertebroplasty worked in the past. |
Kyphoplasty |
7 |
|
Home health or skilled nursing facility with conservative management (including NSAIDs) |
5 |
|
Conservative management including opioids |
3 |
|
Open kyphoplasty |
1 |
|
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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.
Treatment/Procedure |
Rating |
Comments |
Vertebroplasty |
7 |
Patient has already failed conservative management. |
Kyphoplasty |
7 |
Patient has already failed conservative management. |
Home health or skilled nursing facility with conservative management (including NSAIDs) |
5 |
|
Conservative management including opioids |
3 |
|
Open kyphoplasty |
1 |
|
Rating Scale: 1,2,3 Usually not appropriate; 4,5,6 May be appropriate; 7,8,9 Usually appropriate |
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