G.C.Anselmetti, A. Manca, G. Chiara, F. Russo, S. Cirillo, D. Regge (Turino, Italy)
Percutaneous Vertebroplasty (PV), first introduced by Galibert and Deramond in 19871, is gaining acceptance as a first choice treatment for painful osteoporotic compression vertebral fractures and malignancies in the spine when conservative medical therapies failed. Several large clinical studies showed good long-lasting pain relief, rapid rehabilitation and, consequently, improvement of the quality of life 2,3,4,5,6,7,8,9. Polymethylmethacrylate (PMMA) still now represents the most commonly used bone cement in vertebroplasty while different polymers, even with low toxicity and good mechanical properties are still difficult to inject.
The purpose of this preliminary single center study, part of a multi-centric in vivo esperimentation, is to define ease and safety of use of a new water-based Calcium Allmuninate bone cement (Xeraspine, Doxa). A further goal was to monitor pain, quality of life and any potencial adverse events during a one year follow up.
After informed consent 15 patients (12 women, mean age: 73 y.o. age range: 57-91), suffering from painful osteoporotic vertebral collapses (1 to 3) with hyperintensity at MRI fat suppressed sequences, underwent transpedicular PV with a new Calcium Alluminate bone cement called Xeraspine. Vertebral access was obtained with a standard trans-pedicular right approach by means of a 13 Gauges beveled needle inserted under fluoroscopic guidance. Bone cement liquid and powder components were mixed using an electric shaker coming with the cement prototype and 1mL syringes were filled and stored in saline iced bath to prolonge polymerization during PV. Under continuous fluoroscopic control Calcium Alluminate was slowly injected through the beveled needle. Visual Analogue Scale score of pain (VAS from 0 to 100mm) was asked before, within 24hours and at month 1, 3 6, 12 from PV. Oswestry Disability Questionnaire was obtained before PV, after three months and after one year. MRI and lab tests were requested afer one year.
RESULTS: No neurologic or pulmonary complications related to PV procedure nor toxic effects of bone cement occurred. Injectability, radioopacity and filling pattern were good in all cases. A significant backpain regression was achieved in all patients within 24 hours from the procedure. 2 patients (13.3%) had a new fracture respectively within one month and two months. In one patient a further collapse of Th11 (already treated with PV) was detected with MRI performed after one year (VAS increased from a stable 20 to 45 in the last month of the follow up). One patient died within a month for causes unrelated to PV (car accident). The remaining 12 patients had a long lasting pain relief during the first year of follow up (mean pre-PV VAS: 84±14; mean VAS post-PV: 33±20; mean VAS at 12 months: 17±12; mean pre-PV and post-PV Oswestry back pain score were 58±19 and 21±15). Two patients didn’t performed the MRI as scheduled for study termination (one for logistic issues; MRI will be available at month 15 and one, 91 y.o., refused) both patients had an excellent pain relief (VAS 0/100 and 10/100 respectively) and plain x-rays showed any new fracture. No alteration depending on bone cement, nor new fractures were seen in the remaining 10 pts at month 12 MRI. Percutaneus vertebroplasty with Calcium Alluminate was safe and feasible. Pain relief during one year follow up were substantially comparable to expected according to our experience on osteoporotic patients undergone PV with standard PMMA10. Overall new fracture rate (20%: 2 new fractures and one re-fracure) was comparable to the risk of new fracture (19.2%) found in a wide osteoporotic population not treated with PV within one year after the first fracture11.
This study was granted by Doxa
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