Vertebroplasty for Spinal Fractures — the Cement Fix Two Sham Trials Killed in 2009

In 1987 the French neuroradiologist Hervé Galibert reported injecting acrylic bone cement into a single cervical vertebra eaten away by a hemangioma, and by the mid-1990s that salvage technique had been repurposed into a booming outpatient business — percutaneous vertebroplasty for the painful spinal fractures of ordinary osteoporosis — on the strength of nothing but uncontrolled case series in which patients reported feeling better; the gap between that universal operator conviction that the procedure plainly worked and what a blinded comparison actually showed is the entire case. When the procedure was finally tested against a credible fake in 2009, the cement turned out to do nothing the placebo did not do.

The clinical claim was seductive and mechanically intuitive: drive a needle through the back under imaging, inject polymethyl methacrylate (PMMA) into the collapsed vertebral body, stabilize the fracture, and abolish pain — often, operators said, on the table. By the mid-2000s the operation and its cousin kyphoplasty were a multibillion-dollar global market; U.S. Medicare alone was paying for vertebral augmentation in roughly a fifth to a quarter of compression-fracture patients, on the order of tens of thousands of procedures a year. The evidence underneath was almost entirely uncontrolled. Pain from an acute vertebral fracture improves substantially on its own over weeks, and a needle in the back is a powerful theatrical placebo — two facts the case series could not separate from any true effect of the cement.

On 6 August 2009 the New England Journal of Medicine published, in a single issue, two independent randomized double-blind sham-controlled trials. David Kallmes’s multicenter INVEST trial (131 patients) and Rachelle Buchbinder’s Australian trial (78 patients) both gave control patients the full ritual — the same positioning, the same local anesthetic, the same room, the smell of mixed cement — but no PMMA. Both found no meaningful difference. Pain and disability fell sharply in both arms, by roughly the same amount, at every follow-up point.

No agency banned vertebroplasty and no court enjoined it. It was discredited by its own pivotal trials and then slowly throttled by guidelines, payers, and a 2018 Cochrane review, surviving today only as a restricted, narrow-indication option rather than the routine fracture treatment it had been. It stands as the textbook modern lesson that a procedure can feel like it works to every operator and every patient and still be a placebo — and that the only way to know is the sham control almost nobody wanted to run.