Commentary

Consternation and questions about two vertebroplasty trials

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Confronted with the unexpected results of two trials of vertebroplasty, 1,2 physicians are feeling some consternation, We had thought that percutaneous vertebroplasty helps patients with osteoporosis who sustain a painful vertebral insufficiency fracture. However, the trials found it to be no better than a sham procedure in terms of relieving pain.

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How will these findings affect our practice? Should we abandon this popular procedure? Or are there other considerations that may mitigate these negative findings? And what should we tell our patients?

700,000 FRACTURES PER YEAR

Vertebral insufficiency fractures are the most common type of fracture in patients with osteoporosis. Every year in the United States, about 700,000 of them occur.

Nearly two-thirds are asymptomatic. The other one-third typically present with the acute onset of localized pain.

Vertebral insufficiency fractures often lead to chronic pain, impair the ability to walk and to perform daily activities, and accentuate thoracic kyphosis, which in turn can lead to pulmonary restrictive disease, and they raise the risk of death. Also, a patient who has a vertebral insufficiency fracture has a 20% risk of sustaining a new one within 1 year. 3

Whether symptomatic or asymptomatic, finding a vertebral insufficiency fracture should prompt one to consider drug therapy for osteoporosis. In addition, until now, a patient who presented with the acute onset of back pain and whose evaluation revealed a vertebral insufficiency fracture would also be considered for a vertebral augmentation procedure, either vertebroplasty or kyphoplasty, to relieve the pain.

Vertebroplasty involves injecting polymethylmethacrylate cement percutaneously into the affected vertebral body. Kyphoplasty, a similar procedure, uses a balloon to create a cavity in the fractured vertebral body. After the balloon is withdrawn, the cavity is filled with cement.

TWO RANDOMIZED TRIALS OF SHAM VS REAL VERTEBROPLASTY

Two teams, Kallmes et al 2 and Buchbinder et al, 1 independently performed randomized controlled trials to see if vertebroplasty really relieves pain as well as has been reported in open studies, case series, and nonrandomized trials. 4–7

In both trials, patients were randomized to undergo either sham vertebroplasty or real vertebroplasty. The sham procedure closely approximated the real procedure, including inserting a needle, infiltrating a local anesthetic, bupivacaine (Marcaine), into the periosteum of the posterior lamina 1 or the pedicle of the target vertebrae, 2 and opening a vial of polymethylmethacrylate so that the patient would smell the product.

Inclusion criteria

Patients in both trials had to have evidence of a recent (acute) or nonhealed vertebral insufficiency fracture.

Pain was the primary outcome measured

In both trials, the investigators assessed the patients’ pain at baseline and again at several specified intervals, using validated tools.

Kallmes et al assessed pain intensity and functional measures at 1 month (the primary outcome measured), and also at 3, 14, and 90 days and at 1 year.

Buchbinder et al assessed pain at 1 week and at 1, 3, and 6 months. The primary outcome measured was pain at 3 months. Secondary outcomes included quality-of-life measures, pain at rest, and pain at night.

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