Systematic literature review.
To evaluate the safety and efficacy of vertebroplasty and kyphoplasty using the data presented in published clinical studies, with respect to patient pain relief, restoration of mobility and vertebral body height, complication rate, and incidence of new adjacent vertebral fractures.
Vertebroplasty and kyphoplasty have been gaining popularity for treating vertebral fractures. Current reviews provide an overview of the procedures but are not comprehensive and tend to rely heavily on personal experience. This article aimed to compile all available data and evaluate the clinical outcome of the 2 procedures.
This is a systematic review of all the available data presented in peer-reviewed published clinical trials. The methodological quality of included studies was evaluated, and data were collected targeting specific standard measurements. Where possible, a quantitative aggregation of the data was performed.
A large proportion of subjects had some pain relief, including 87% with vertebroplasty and 92% with kyphoplasty. Vertebral height restoration was possible using kyphoplasty (average 6.6°) and for a subset of patients using vertebroplasty (average 6.6°). Cement leaks occurred for 41% and 9% of treated vertebrae for vertebroplasty and kyphoplasty, respectively. New fractures of adjacent vertebrae occurred for both procedures at rates that are higher than the general osteoporotic population but approximately equivalent to the general osteoporotic population that had a previous vertebral fracture.
The problem with stating definitely that vertebroplasty and kyphoplasty are safe and effective procedures is the lack of comparative, blinded, randomized clinical trials. Standardized evaluative methods should be adopted.
The safety and efficacy of vertebroplasty and kyphoplasty were evaluated through a systematic review of the literature. Although pain relief appears to be almost universal, other measurements and complications are still controversial. Target research areas have been specified and a need for standardized evaluative methods identified.
From the *M.E. Müller Institute for Surgical Technology and Biomechanics, Bern, and †Spine Center, Thun, Switzerland.
Acknowledgment date: February 16, 2005. First revision date: July 15, 2005. Second revision date: October 14, 2005. Acceptance date: October 19, 2005.
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
Foundation funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript.
Address correspondence and reprint requests to Paul A. Hulme, MSc, Research Center for Orthopaedic Surgery, Institute for Surgical Technology and Biomechanics, University of Bern, Stauffacherstr. 78, 3014 Bern, Switzerland; E-mail: Paul.Hulme@MEMcenter.unibe.ch