1. 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

2. 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

3. 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

4. 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

5. 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

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

7. 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%

8. 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!

9. 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

10. 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:
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

11. 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

12. 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.