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J Am Coll Surg. 2014 Sep;219(3):525-33.e1. doi: 10.1016/j.jamcollsurg.2014.03.047. Epub 2014 Apr 29.

Impact of negative clinical trial results for vertebroplasty on vertebral augmentation procedure rates.

Author information

1
Department of Health Studies, University of Chicago, Chicago, IL. Electronic address: fsmiel@uchicago.edu.
2
Department of Neurosurgery, Baylor College of Medicine, Texas Children's Hospital, Houston, TX.
3
Department of Health Policy and Management, Emory University, Atlanta, GA.

Abstract

BACKGROUND:

Vertebroplasty and kyphoplasty are procedures for treating vertebral compression fractures (VCFs). In August 2009, 2 randomized trials in the New England Journal of Medicine found that vertebroplasty did not reduce pain or disability relative to a sham procedure among patients with osteoporotic VCFs.

STUDY DESIGN:

We evaluated quarterly trends in per capita rates of vertebroplasties and kyphoplasties using the Florida hospital inpatient discharge and ambulatory surgery center databases from 2005 to 2012, supplemented with physician specialty and population data. We reported trends by procedure type, patient diagnosis, and physician specialty. We modeled the procedures as interrupted time series with a break when the clinical trials were published, and estimated changes in procedure rates and health expenditures resulting from the trials.

RESULTS:

The trials led to a 51.5% decline in the per capita vertebroplasty rate and a 40.0% decline in the kyphoplasty rate (both results p < 0.010) compared with what procedure rates would have been without the trials. Vertebroplasty rates for interventional radiologists displayed no significant change; rates for surgeons and other specialists declined by 73.1% (p < 0.010). Overall, these changes imply nationwide health expenditure savings of just over $1 billion per year.

CONCLUSIONS:

Publication of negative clinical trial results led to moderate reductions in vertebroplasties and kyphoplasties for osteoporotic VCFs. However, vertebroplasty and kyphoplasty continue to be widely used to treat patients with osteoarthritis. Substantial differences in response across physicians suggest an important role for specialty society clinical guidelines in modulating how clinical evidence is incorporated into routine practice.

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