This multicenter, double-blind RCT compared vertebroplasty to a sham procedure in 78 patients with painful osteoporotic vertebral fractures confirmed on MRI. It directly tested whether PMMA injection confers benefit beyond placebo in this population. Outcomes were assessed at 1 week and 1, 3, and 6 months.
Before this paper, vertebroplasty was rapidly expanding based on observational data showing dramatic pain relief. Reimbursement approvals had nearly doubled procedure rates in U.S. Medicare patients within 5 years, despite the absence of sham-controlled trial evidence.
This RCT — published simultaneously with a second sham-controlled trial (Kallmes et al., also NEJM 2009). Established that the pain relief attributed to vertebroplasty is indistinguishable from placebo. When you see an elderly patient with an acute osteoporotic compression fracture, aggressive conservative management (analgesia, bisphosphonates, bracing) remains the evidence-based first-line approach.
This paper is why vertebroplasty is not routinely indicated for acute osteoporotic VCFs and why shared decision-making must include honest disclosure that cement injection may offer no more benefit than a well-managed sham.
A key nuance: all patients required MRI-confirmed bone marrow edema (acute fracture signal) for enrollment, so these results apply specifically to the acute-subacute fracture population. The very group most often offered the procedure.
This multicenter, double-blind RCT compared vertebroplasty to a sham procedure in 78 patients with painful osteoporotic vertebral fractures confirmed on MRI. It directly tested whether PMMA injection confers benefit beyond placebo in this population. Outcomes were assessed at 1 week and 1, 3, and 6 months.
Before this paper, vertebroplasty was rapidly expanding based on observational data showing dramatic pain relief. Reimbursement approvals had nearly doubled procedure rates in U.S. Medicare patients within 5 years, despite the absence of sham-controlled trial evidence.
This RCT — published simultaneously with a second sham-controlled trial (Kallmes et al., also NEJM 2009). Established that the pain relief attributed to vertebroplasty is indistinguishable from placebo. When you see an elderly patient with an acute osteoporotic compression fracture, aggressive conservative management (analgesia, bisphosphonates, bracing) remains the evidence-based first-line approach.
This paper is why vertebroplasty is not routinely indicated for acute osteoporotic VCFs and why shared decision-making must include honest disclosure that cement injection may offer no more benefit than a well-managed sham.
A key nuance: all patients required MRI-confirmed bone marrow edema (acute fracture signal) for enrollment, so these results apply specifically to the acute-subacute fracture population. The very group most often offered the procedure.