Etude Free 2 ans B.Cortet

11h00-11h20 Etude Free 2 ans B.Cortet

Transcript

1. FREE: Fracture REduction Evaluation study A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Care for Patients with B. Cortet, D. Wardlaw, L. Bastian, J. Van Meirhaeghe and S. Boonen for the FREE Study Investigators
2. Inclusion/Exclusion Criteria Major Inclusion Criteria  Up to 3 VCF due to osteoporosis, multiple myeloma or osteolytic metastatic tumors  At least one with edema on MRI  At least one with ≥ 15% height loss  Numerical pain scale VAS (0-10) ≥ 4 Major Exclusion Criteria  Previous vertebroplasty  Old fractures (> 3 months)  Spinal cord compression  History of disabling back pain, not caused by the VCF  Dementia  Unable to walk prior to fracture
3. Study Design Balloon Kyphoplasty (BKP) Pictures: courtesy of Dr E. Trumees Non Surgical Management (NSM) Treatment according to hospital protocol - Pain medication - Bracing - Physiotherapy - Bed rest Start treatment 5-10 days 1 month 3 month 6 month 12 month 18 month 24 month Randomization Fracture MRI Screening Baseline ≤ 3 months 151 128 111 115 117 138 124 131 134 149 300 patients
4. » Primary Endpoint  PCS-Summary (Physical Component Summary) of the SF-36 Quality of Life Questionnaire at one month » Secondary Endpoints (1, 3, 6 and 12 months)  SF-36 subscales  Back pain: (0-10) numerical pain score (VAS)  Back function: Roland Morris Disability Questionnaire  Global health outcome (EQ-5D)  Days of limited activity  Device and procedure related safety Endpoints
5. Demographics 149 115 (77%) 72.2 (± 9.3) 49 (33%) 12 (8%) 63% 27% 145 (97%) 2 (1.3%) 2 (1.3%) 151 115 (77%) 74.1 (± 9.4) 143 (95%) 6 (4.0%) 2 (1.3%) 77% 31% 49 (32%) 17 (11%)
6. Baseline Fractures per Patient
7. Baseline Fractures per Patient
8. Primary Endpoint – PCS SF-36 @ 1 Month Change from baseline BKP versus NSM at 1 Month : p<0,0001 25.54 25.97 27.42 33.43
9. SF-36 Physical Component Score : 1 year FU
10. Swedisch aged-matched normative values for women > 74 years (Sullivan et al. 2002) SF-36 Physical Component Score : 1 year FU
11. SF-36 Physical Component Score: 2 year FU
12. SF-36 Physical Component Score: 2 year FU Swedisch aged-matched normative values for women > 74 years (Sullivan et al. 2002)
13. Global Health Outcome
14. Global Health Outcome Post-fracture and post-fracture12 months scores for vertebral osteoporotic fractures treated conservatively (Borgström et al. ,OI, 2006)
15. Back Pain
16. Back Function The RMDQ-Minimal Clinical Important Difference (MCID) is 2.5 points Balloon Kyphoplasty reaches this difference at each measured time point
17. Disability: 1 year FU Assessment of limited activity days (within 2 weeks)
18. Disability: 2 year FU Assessment of limited activity days (within 2 weeks)
19. Safety » Serious Adverse Events, procedure related (1.3%)  1 subcutaneous haematoma  1 urinary tract infection » No cement related adverse events » Adverse Events  No statistical difference between groups  No difference in subsequent fractures
20. Conclusions » Significant better improvement in quality of life in the BKP group than in the NSM group » Significant more pain reduction in the BKP group than in the NSM group » Significant less need for narcotics in the BKP group than in the NSM group » Low complication rate 2/149 (1.3%) » No statistical difference in subsequent fractures between BKP and NSM