Long-Term Data for 884 Patients Show Vertebroplasty for Osteoporotic Spinal Fractures Provides Dramatic Pain Relief, Greatly Decreases Disability Giovanni Carlo ANSELMETTI, MD Institute for Cancer Research and Treatment Candiolo (TURIN) - Italy

Percutaneous Vertebroplasty STUDY DESIGN We prospectively evaluated back-pain improvement, new fracture rate and complications in a large series of Osteoporotic Patients underwent to Percutaneous Vertebroplasty for vertebral fracture refractory to conservative medical treatment

Patients Populations 884 Patients (750 female - 134 male mean age 73,1 years) 639 Primary Osteoporosis (72,3%) 245 Secondary to Steroidal therapy (27,7%) Treated on 3954 Vertebrae All procedures in Local anesthesia Patients discharged from the Hospital the same procedural day

Clinical Evaluation Pain was evaluated using a 11-point Visual Analogic Scale from 0 (no pain) to 10 (worst experienced pain) before and after the procedure. Disability improvement was evaluated by external Brace support and Oswestry Disability Questionnaire before and after Vertebroplasty If patients reported back-pain recurrence during follow-up clinical interview and MRI were performed to investigate new vertebral fracture

845/884 patients (95,6%) reported backpain improvement Visual Analog Scale Pre e Post VTP 884 patients Follow-up up to 52 months P<0.0001 Wilcoxon signed rank Test SD±1,5 SD±1,8 845/884 patients (95,6%) reported backpain improvement

Quality of Life after PV Brace support Follow-up up to 52 months McNemar’s Test

Quality of Life Oswestry Disability Questionnaire 884 Pts Paired t test SD ±13,5% Considering together patients treated with PVP and Osteoplasty (a total of two hundred and twenty six), the Oswestry questionnaire showed a statistical high significant difference (unpaired t test with Welch correction was used): average of sixty-eight percent before the procedure dropped to eighteen percent after the needle and cement of the interventional radiologist. SD±6,9%

New Fractures in Osteoporosis 884 Patients - Follow-up up to 52 months During follow-up all patients were invited to contact us whenever backpain occurred again after PV. MR and plain radiograms showed a new vertebral fractures in: 106 patients (12%) Occurred 15 days to 36 months (mean 9,4±8,7 months) after previous Vertebroplasty They were all successfully retreated!

Fract. on Contiguous vertebra New Fractures in Osteoporosis Fracture on Contiguous vertebra 73/106 patients (68,9%) Pts Retreated Fract. on Contiguous vertebra % Binomial exact Test 106 73 68,9 Two-tail P<0,001 Highly significant

RETREATMENTS in Osteoporosis New Fracture during 18 months Follow-up Vertebroplasty vs. Placebo & Teriparatide Osteoporotic Pts with 1 or more vertebral collapses at baseline New Fracture During 18 months % Chi-square Vertebroplasty Personal Series 547 75 13,7 Placebo Lindsay et al. Arch Intern Med 2004; 164:2024-2030. 353 67 18,9 P=0.04 Signifcant difference! 20µG Teriparatide 373 42 11,2 P=0.3 No difference! 40µG Teriparatide 345 36 10,4 P=0.18

COMPLICATIONS 18/884 patients (2%) Vertebroplasty was completed in all patients without any major complications 12 (1,4%) asymptomatic pulmonary embolism 6 (0,7%) nerve root irritation successfully treated by local steroidal injection

CONCLUSIONS Vertebroplasty is safe and effective in the treatment of back-pain due to osteoporotic vertebral collapses. After Vertebroplasty patients can increase mobility and improve their quality of life. New fracture rate seems to be similar to not PV-treated osteoporotic pts reported by literature. Our data suggest that Vertebroplasty should always be proposed to patients when conservative medical treatment fails. A low complications rate can be achieved by good technique, experienced physicians and state of the art radiological equipment. Randomized studies have to be performed in the future to assess if vertebroplasty should be considered as “conventional therapy” in the treatment of not surgical vertebral fracture. Thank you for you attention.