A Randomized Trial of Vertebroplasty for Osteoporotic Spinal Fractures

N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563.

Abstract

Background: Vertebroplasty is commonly used to treat painful, osteoporotic vertebral compression fractures.

Methods: In this multicenter trial, we randomly assigned 131 patients who had one to three painful osteoporotic vertebral compression fractures to undergo either vertebroplasty or a simulated procedure without cement (control group). The primary outcomes were scores on the modified Roland-Morris Disability Questionnaire (RDQ) (on a scale of 0 to 23, with higher scores indicating greater disability) and patients' ratings of average pain intensity during the preceding 24 hours at 1 month (on a scale of 0 to 10, with higher scores indicating more severe pain). Patients were allowed to cross over to the other study group after 1 month.

Results: All patients underwent the assigned intervention (68 vertebroplasties and 63 simulated procedures). The baseline characteristics were similar in the two groups. At 1 month, there was no significant difference between the vertebroplasty group and the control group in either the RDQ score (difference, 0.7; 95% confidence interval [CI], -1.3 to 2.8; P=0.49) or the pain rating (difference, 0.7; 95% CI, -0.3 to 1.7; P=0.19). Both groups had immediate improvement in disability and pain scores after the intervention. Although the two groups did not differ significantly on any secondary outcome measure at 1 month, there was a trend toward a higher rate of clinically meaningful improvement in pain (a 30% decrease from baseline) in the vertebroplasty group (64% vs. 48%, P=0.06). At 3 months, there was a higher crossover rate in the control group than in the vertebroplasty group (51% vs. 13%, P<0.001) [corrected]. There was one serious adverse event in each group.

Conclusions: Improvements in pain and pain-related disability associated with osteoporotic compression fractures in patients treated with vertebroplasty were similar to the improvements in a control group. (ClinicalTrials.gov number, NCT00068822.)

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Aged
  • Back Pain / etiology
  • Back Pain / therapy
  • Bone Cements
  • Cross-Over Studies
  • Disability Evaluation
  • Double-Blind Method
  • Female
  • Fractures, Compression / complications
  • Fractures, Compression / therapy*
  • Humans
  • Injections, Spinal
  • Male
  • Osteoporosis / complications*
  • Outcome Assessment, Health Care
  • Pain Measurement
  • Placebo Effect
  • Polymethacrylic Acids
  • Spinal Fractures / etiology
  • Spinal Fractures / therapy*
  • Treatment Failure
  • Vertebroplasty* / adverse effects
  • Vertebroplasty* / methods

Substances

  • Bone Cements
  • Polymethacrylic Acids
  • polymethacrylic acid

Associated data

  • ClinicalTrials.gov/NCT00068822