Vertebroplasty for osteoporotic vertebral fracture
Authors: Robert G W Lambert, Kamran Golmohammadi
Journal: BMJ (2008)

The first percutaneous injection of bone cement into the spine was performed in 1984 to treat a 54 year old woman with extreme pain caused by a haemangioma in the second cervical vertebra. Surprisingly, pain relief was complete.1 After the case was published, indications for percutaneous vertebroplasty quickly expanded to include treatment of chronic back pain caused by metastases and osteoporotic fracture.

Since then, many case series have indicated that vertebroplasty is an effective way to control the pain of vertebral compression fracture caused by osteoporosis. The immediate relief of pain is often dramatic and, especially for the chronically debilitated patient, it may seem miraculous. The results are fairly consistent, and in one large case series of 552 patients, improvement in pain and disability persisted throughout two years of follow-up.2 Unfortunately, in the only published randomised controlled trial of vertebroplasty, almost all patients in the control group—who received conservative care—crossed over to the intervention group two weeks after randomisation, so the results were difficult to interpret.3

At present, guidelines for selecting which patients to treat with vertebroplasty are vague. The National Institute for Health and Clinical Excellence (NICE) interventional procedure guidance 12 states that “the procedure should be limited to patients whose pain is refractory to more conservative treatment.” With respect to efficacy, “the opinions of the specialist advisors were divided.”

Standards of care for debilitated patients vary greatly between jurisdictions as a result of differences in home support, insurance coverage, or access to private care. Rigorous supervision of non-hospital care before vertebroplasty may be difficult for the specialist physician trying to ensure that all patients undergo “adequate trial of optimised conservative treatment.” The problem is exaggerated if patients have difficulty in travelling to and from appointments—in Canada and the United States home visits by doctors are rare.

In some centres in North America, patients with “failure of conservative treatment” can be directly referred for vertebroplasty by emergency departments. In this setting, the effects of the procedure may be exaggerated for several reasons—patients are very appreciative of rapid pain relief; doctors’ perceptions of results are positively reinforced by the immediacy of the effect and early discharge from hospital; and the hospital administration may benefit financially. The problem is compounded in health systems that reward action rather than observation and in clinical services that compete to provide “better care.” In this context, failure of conservative treatment could become a euphemism for inadequate care.

So what constitutes failure of conservative management? No definition of a standard approach for initial conservative treatment can be found in the literature. No agreed guidelines exist for the minimum duration of conservative management or whether this should vary according to age or condition. Options for conservative care are seldom described in any meaningful way. For example, high dose calcitonin for controlling pain of bony origin is rarely considered, even though it is a highly effective analgesic for osteoporotic vertebral fracture.4 5 Only occasionally is advice given about bed rest.6 Furthermore, few publications stress the palliative nature of vertebroplasty, especially in osteoporosis, and that the procedure does have risks. Serious complications of vertebroplasty include paraplegia, pulmonary cement embolism, and death.7

A recently published position statement on percutaneous vertebral augmentation with vertebroplasty or kyphoplasty (balloon vertebroplasty) discussed the evidence for the poor prognosis of chronic pain and disability in elderly people. This evidence is used as a justification for vertebroplasty, and the statement concludes that this procedure is “established therapy and should be reimbursed by payors as a safe and effective treatment for painful compression fractures.”8 However, although early follow-up results of two non-randomised controlled studies showed significant improvement in pain in the vertebroplasty group, three or six months later the differences between groups were not sustained.9 10 There is no good evidence that vertebroplasty has a better long term outcome, and it may even accelerate the rate of new fractures.11 12 Also, because vertebroplasty does not treat the underlying condition, if immediate pain relief detracts attention away from the seriousness of the osteoporosis, might this constitute an adverse effect?

Although evidence is currently lacking, immediate access to vertebroplasty could be more effective than conservative treatment. Conservative measures such as narcotic analgesia and bed rest have side effects that are often magnified in elderly debilitated people. Hospital care is expensive and faster rehabilitation may be preferable. However, without high quality evidence, selection criteria for the procedure may become less clear over time as new devices and instruments are developed to expand the application of the technique. Competition between manufacturers is more likely to cloud rather than to clarify these matters.

With good training and equipment, vertebroplasty is a relatively simple interventional procedure; its immediate effects are well documented; and its use is perhaps justified as a treatment for severe chronic debilitating pain caused by osteoporotic vertebral fracture. Of course these decisions should be made by a multidisciplinary team of clinicians experienced in osteoporosis, pain and rehabilitation, and vertebroplasty, who would be responsible for management and follow-up. Randomised controlled trials are essential to define the minimum conservative treatment that patients should receive before vertebroplasty, and to develop clear guidelines on the use of vertebroplasty that would help to prevent its indiscriminate use.