Institute for Cancer Research and Institute for Cancer Research and Treatment Candiolo (TURIN) - Treatment Candiolo (TURIN) -

ItalyItaly

Long-Term Data for 884 Patients Show Long-Term Data for 884 Patients Show Vertebroplasty for Osteoporotic Spinal Vertebroplasty for Osteoporotic Spinal

Fractures Provides Dramatic Pain Fractures Provides Dramatic Pain Relief, Greatly Decreases DisabilityRelief, Greatly Decreases Disability

Giovanni Carlo ANSELMETTI, MDGiovanni Carlo ANSELMETTI, MD

Percutaneous VertebroplastyPercutaneous VertebroplastySTUDY DESIGNSTUDY DESIGN

We prospectively evaluated We prospectively evaluated back-pain back-pain improvementimprovement, , new fracturenew fracture rate and rate and

complicationscomplications in a large series of in a large series of OsteoporoticOsteoporotic Patients underwent to Patients underwent to

Percutaneous VertebroplastyPercutaneous Vertebroplasty for for vertebral fracture refractory to vertebral fracture refractory to conservative medical treatmentconservative medical treatment

Patients PopulationsPatients Populations884 Patients884 Patients

(750 female - 134 male mean age 73,1 years(750 female - 134 male mean age 73,1 years))

639639 Primary Osteoporosis Primary Osteoporosis (72,3%)(72,3%)

245245 Secondary to Steroidal therapy Secondary to Steroidal therapy (27,7%) (27,7%)

Treated on Treated on 39543954 VertebraeVertebrae

All procedures in All procedures in Local anesthesiaLocal anesthesia

Patients discharged from the Hospital the Patients discharged from the Hospital the same same

procedural dayprocedural day

Clinical EvaluationClinical EvaluationPain 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

Visual Analog Scale Pre e Post VTPVisual Analog Scale Pre e Post VTP884 patients884 patients

Follow-up up to 52 monthsFollow-up up to 52 months

7,9

1,3

0,0

1,0

2,0

3,0

4,0

5,0

6,0

7,0

8,0

VAS Score

mean VAS

Before After

P<0.0001P<0.0001Wilcoxon signed rank TestWilcoxon signed rank TestSD±1,5SD±1,5

SD±1,8SD±1,8

845/884 845/884 patientspatients (95,6%)(95,6%) reported backpain reported backpain improvementimprovement

Quality of Life after PVQuality of Life after PVBrace supportBrace support

Follow-up up to 52 monthsFollow-up up to 52 months

694

1020

100

200300

400

500

600

700

Brace before PV Brace after PV

P<0.0001P<0.0001McNemar’s TestMcNemar’s Test

Quality of Life Quality of Life Oswestry Disability QuestionnaireOswestry Disability Questionnaire

884 Pts884 Pts

69,3%

18,8%

0,0%

10,0%

20,0%

30,0%

40,0%

50,0%

60,0%

70,0%

80,0%

90,0%

100,0%

Before Post

P<0.0001P<0.0001Paired t testPaired t test

SD SD ±±13,5%13,5%

SDSD±±6,9%6,9%

New Fractures in OsteoporosisNew Fractures in Osteoporosis884 Patients - Follow-up up to 52 months884 Patients - Follow-up up to 52 months

During follow-up all patients were invited to contact us whenever During follow-up all patients were invited to contact us whenever backpain occurred again after PV.backpain occurred again after PV.

MR and plain radiograms showed a new vertebral fractures in:MR and plain radiograms showed a new vertebral fractures in:

106106 patients patients ((12%12%))OccurredOccurred 15 days to 36 months 15 days to 36 months (mean 9,4±8,7 months)(mean 9,4±8,7 months) after previous after previous

VertebroplastyVertebroplasty

They were all successfully retreated!They were all successfully retreated!

New Fractures in OsteoporosisNew Fractures in OsteoporosisFracture on Contiguous vertebraFracture on Contiguous vertebra

73/106 patients (68,9%)73/106 patients (68,9%)

Pts Retreated Fract. on Contiguous vertebra % Binomial exact Test

106 73 68,9Two-tail

P<0,001Highly significant

RETREATMENTS in OsteoporosisRETREATMENTS in OsteoporosisNew Fracture during 18 months Follow-upNew Fracture during 18 months Follow-upVertebroplasty vs. Placebo & TeriparatideVertebroplasty vs. Placebo & Teriparatide

Osteoporotic Pts with 1 or more vertebral collapses at baseline

New Fracture

During 18 months %Chi-square

VertebroplastyPersonal Series

547 75 13,7

PlaceboLindsay et al. Arch Intern Med 2004; 164:2024-

2030. 353 67 18,9

P=0.04Signifcant difference!

20µG TeriparatideLindsay et al. Arch Intern Med 2004; 164:2024-

2030.

373 42 11,2 P=0.3No difference!

40µG TeriparatideLindsay et al. Arch Intern Med 2004; 164:2024-

2030.

345 36 10,4 P=0.18No difference!

COMPLICATIONSCOMPLICATIONS18/884 patients (2%)18/884 patients (2%)

12 (1,4%)12 (1,4%) asymptomatic pulmonary embolism asymptomatic pulmonary embolism

6 (0,7%)6 (0,7%) nerve root irritation successfully treated nerve root irritation successfully treated

by local steroidal injectionby local steroidal injection

Vertebroplasty was completed in all patients Vertebroplasty was completed in all patients without any major complicationswithout any major complications

CONCLUSIONSCONCLUSIONSVertebroplastyVertebroplasty is is safe and effectivesafe and effective in the in the

treatment of back-pain due to osteoporotic treatment of back-pain due to osteoporotic vertebral collapses.vertebral collapses.

After VertebroplastyAfter Vertebroplasty patients can patients can increase increase mobilitymobility and and improveimprove their their quality of lifequality of life. .

New fractureNew fracture rate seems to be rate seems to be similar to not PV-similar to not PV-treated osteoporotic ptstreated osteoporotic pts reported by literature. reported by literature.

Our data suggest that Our data suggest that VertebroplastyVertebroplasty should should always be proposedalways be proposed to patients to patients when when conservative medical treatment failsconservative medical treatment fails..