ORIGINAL ARTICLE Percutaneous Cement Injection into a Created Cavity for the Treatment of Vertebral Body Fracture Preliminary Results of a New Vertebroplasty Technique Ricardo Vallejo, MD, PhD, FIPP, Ramsin Benyamin, MD, DABPM, FIPP, Bonnie Floyd, PhD, Joseph M. Casto, PhD, Ninos J. Joseph, BS, and Nagi Mekhail, MD, PhD, FIPP Objectives: Vertebral body fractures (VBFs) are the most common complication of osteoporosis. Minimally invasive placement of ce- ment to stabilize VBFs results in significant pain reduction and im- proved performance of daily activities. The authors describe a modi- fied percutaneous vertebroplasty (PV) procedure during which a cavity is created manually in the VBF, allowing the cement to be in- jected with less resistance. Methods: Data were gathered from a retrospective chart review from 15 consecutive patients with acute compression VBFs who un- derwent 33 PV procedures with the Cavity Creation System. Mean follow-up was 30 weeks. Oral opiate intake, quality of life improve- ment, and visual analog pain scores (VAS) were measured before and 1 month after the procedure. Results: All 15 patients exhibited a reduction in pain VAS (mean reduction 5.9 6 2.5). Improvement in quality of life was demon- strated by lower (improved) FACIT scores in the General Activity, Enjoyment of Life, Mood, Normal Work Routine, and Sleep subscales. In addition, opioid use decreased in 10 of the 12 (83%) patients who were taking opioids before surgery. In eight (67%) patients, opioid use decreased by over 50%. Complications included extrusion of cement in two patients (an incidence of 5.7% of the levels operated) and two patients with intraoperative rib fractures. No postoperative neurologic deficits were noted. Conclusions: The Cavity Creation System is a safe, cost-effective treatment of VBF resulting in good/excellent pain relief and an improved quality of life. Key Words: percutaneous vertebroplasty, osteoporosis, pain relief, FACIT (Clin J Pain 2006;22:182–189) V ertebral body fractures (VBFs) are the most common com- plication of osteoporosis, with 700,000 cases annually. 1 Minimally invasive placement of cement to stabilize these fractures results in significant pain reduction and improved performance of daily activities. Procedures to deliver cement into fractured vertebrae include both percutaneous vertebro- plasty (PV) and kyphoplasty (Kyphon, Inc, Sunnyvale, CA). PV involves the injection of polymethylmethacrylate cement into an injured vertebral body via a needle that is placed per- cutaneously either using a transpedicular or extrapedicular approach. Pain relief is thought to be achieved via stabilization and reinforcement of the fractured vertebral body. 1 Because the cement must be forced into the cancellous bone matrix and because of the low viscosity of the injectate, incidences of cement extrusion range from 9.2% to 73%. 2–4 Recently, Tomita et al 5 have cast doubt on these assumptions by finding minimal pressure increases (9.4 6 8.5 mm Hg) during direct injection of cement into ex vivo cadaveric osteoporotic ver- tebral bodies during PV. We describe a modified PV procedure that employs the Cavity Creation System (CCS; Synthes-Stratec, Inc., Oberdorf, Switzerland) to manually create a cavity in frac- tured vertebral bodies under fluoroscopic guidance. This sys- tem consists of a disposable approach kit and a reusable hinged-tip curet set comprising varying lengths and sizes (Fig. 1). This modified procedure allows a more viscous cement to be injected with low resistance. Like conventional PV, this pro- cedure is performed under monitored anesthesia care and local anesthesia and requires no hospital admission. We present our experience to date with the CCS to treat 33 VBFs in 15 patients. METHODS Data were gathered from a retrospective chart review of synchronized protocols from 15 consecutive patients (14 women, 1 man) with acute compression VBFs treated with the CCS. The patients ranged in age from 50 and 83 years (Table 1). A total of 33 VBFs were treated in these 15 patients. The number of VBFs treated per patient varied between one and five levels (Table 2). Patient Selection Criteria Patients considered for treatment using the CCS met all of the following inclusion criteria: acute or subacute diagnosis Received for publication September 29, 2004; revised February 27, 2005; accepted March 25, 2005. From the Millennium Pain Center, the Central Illinois Neuroscience Foundation, Bloomington, IL; and the Department of Pain Management, Cleveland Clinic Foundation, Cleveland, OH. Presented at the 20th Annual Meeting of the American Academy of Pain Medicine, Orlando, FL, March 4–7, 2004. Reprints: Ricardo Vallejo, MD, PhD, Millennium Pain Center, 1015 South Mercer Avenue, Bloomington, IL 61701 (e-mail: vallejo1019@yahoo. com). Copyright Ó 2006 by Lippincott Williams & Wilkins 182 Clin J Pain  Volume 22, Number 2, February 2006 Copyright ' Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.