Aulisa Angelo Gabriele, Guzzanti V, Giordano M, Falciglia F, Fuiano M* and Aulisa L*.

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1 UOC Orthopaedic and Traumatology Childrens Hospital Bambino Gesu, Rome, Italy Is the measurement in Cobb degrees the only parameter to be considered in the conservative treatment of adolescent idiopathic scoliosis with curves over 40? Aulisa Angelo Gabriele, Guzzanti V, Giordano M, Falciglia F, Fuiano M* and Aulisa L*. *Department of Orthopaedics Università Cattolica del Sacro Cuore, Rome, Italy

2 Background References Rigo M, Reiter C, Weiss H. Pediatr Rehabil 2003 Maruyama T, Kitagawa T, et al. Pediatr Rehabil 2003 Negrini S, Minozzi S et al. Spine 2010 Aulisa AG, Guzzanti V, et al. Scoliosis 2010 Negrini S, Negrini F, et al. Spine J 2011 Aulisa AG, Guzzanti V, et al. Spine 2011 Aulisa AG, Guzzanti V, et al. Spine 2012 Weinstein SL, Dolan et al. N Engl J Med. 2013

3 Background References Recently, positive results in bracing patients with idiopathic scoliosis above 45 who refused surgery have been presented.

4 Primary aim Evaluate the effectiveness of the brace in idiopathic scoliosis with curves above 40, followed the guidelines on standard of management of idiopathic scoliosis SOSORT Secondary aim Assess if the magnitude of the curve in Cobb degrees is the only parameter for the indication to surgical or conservative treatment SOSORT guidelines: Orthopaedic and Rehabilitation treatment of idiopathic scoliosis during growth.negrini S, Aulisa AG, et al.; Scoliosis Jan 20;7(1):3.

5 Methods Inclusion Criteria Curve magnitude over 40 Risser 0-4 Patients deny any surgical treatment

6 Methods From a prospective database of 1398 patients treated for idiopathic scoliosis between 1993 and 2014 fulfill the inclusion criteria 160 patients.

7 Methods 160 patients fulfilled the inclusion criteria: Full-time (max 22 hours daily, min 18) Weaning was started at ring-apophyses fusion Minimum Follow-up of 24 months

8 Methods Clinical controls were performed every 2-3 months. X-ray a: beginning of treatment (T1) one year after the beginning of treatment(t2) intermediate time between t1 and t4 (T3) end of weaning (T4) 2-year minimum follow-up from t4 (T5) X-ray measurements of the curve magnitude (CM, Cobb's method) and torsion of the apical vertebra (TA: Perdriolle's method) were obtained by two independent observers.

9 Methods Primary Aim Three outcomes were distinguished in agreement with SRS criteria: Correction if t5-t1-5 Cobb Stabilization if -5 <t5-t1>5 Cobb Progression if t5-t1 5 Cobb Analisi statistica con Kruskal-Wallis H Test (p<0.05)

10 Methods Secondary aim We have divided the sample in subgroup according to: Risser (0-2; 3-4) Pedriolle (<20; 20) Cobb ( 45 ;>45 ) Type of Curve Analisi statistica con Kruskal-Wallis H Test (p<0.05)

11 160 Patients Results 28 in treatment 104 at follow up correction stabilization progression 9% 14% 77% 28 have abandoned treatment correction stabilization progression 4% 14% 82% 16 recommended for surgery 5 recommended for surgery

12 Analyses of 104 patients with definite outcomes: Results Mean age was 12.88±1.86 at t1 and 17.92±1.65 at t4. Mean duration of treatment was 63.12±17.44 months Follow-up 60.86±57.85 (range ) months Cobb 47.02±5.25 at t1 and 34.19±8.45 at t5. Perdriolle 20.04±5.53 at t1 and 16.76±7.04 at t Cobb Perdriolle Beginning Follow Up

13 Degrees C t1 Total Sample Cobb Degrees C t2 C t3 C t4 C t5 Results Bonferroni's Multiple Comparison Test Mean Diff t P < 0,05? Summary 95% CI of diff C t1 vs C t2 16,23 14,54 Yes *** 13,08 to 19,38 C t1 vs C t3 19,44 17,42 Yes *** 16,30 to 22,59 C t1 vs C t4 18,46 16,42 Yes *** 15,29 to 21,63 C t1 vs C t5 12,83 11,23 Yes *** 9,609 to 16,05 C t2 vs C t3 3,212 2,878 Yes * 0,06477 to 6,358 C t2 vs C t4 2,234 1,987 No ns 0,9360 to 5,404 C t2 vs C t5 3,401 2,978 Yes * 6,621 to 0,1806 C t3 vs C t4 0,9775 0,8694 No ns 4,148 to 2,193 C t3 vs C t5 6,613 5,789 Yes *** 9,833 to 3,392 C t4 vs C t5 5,635 4,899 Yes *** 8,878 to 2,392 Degrees P t1 Perdriolle Degrees P t2 P t3 P t4 P t5 Bonferroni's Multiple Comparison Test Mean Diff t P < 0,05? Summary 95% CI of diff P t1 vs P t2 2,767 1,406 No ns 4,526 to 10,06 P t1 vs P t3 3,907 1,986 No ns 3,385 to 11,20 P t1 vs P t4 4,910 2,457 No ns 2,495 to 12,31 P t1 vs P t5 3,278 1,636 No ns 4,147 to 10,70 P t2 vs P t3 1,141 0,5783 No ns 6,169 to 8,451 P t2 vs P t4 2,143 1,070 No ns 5,279 to 9,565 P t2 vs P t5 0,5114 0,2547 No ns 6,930 to 7,953 P t3 vs P t4 1,002 0,5004 No ns 6,420 to 8,424 P t3 vs P t5 0,6293 0,3134 No ns 8,071 to 6,812 P t4 vs P t5 1,632 0,8006 No ns 9,184 to 5,921 Significant differences were determined for the Cobb angle across t 1, t 2, t 3, t 4, t 5 (P<0.0001)

14 Risser Results Risser 0 2 Mean diff t p<0,05 95% CI of diff Time vs Risser 67,33 28,71 Yes *** 58,69 to 75,98 Risser vs Ct5 t1 16,07 6,774 Yes *** 7,329 to 24,82 Risser vs Rot5 1 4,855 2,012 No ns 4,038 to 13,75 Risser vs follow up 59,5 24,87 Yes *** 68,32 to 50,68 Risser vs Cobb fol up 30,33 12,73 Yes *** 39,11 to 21,55 Risser 3 5 Mean diff t p<0,05 95% CI of diff Time vs Risser 49,67 13,47 Yes *** 36,04 to 63,29 Risser vs Ct5 t1 9,83 2,587 No ns 4,213 to 23,87 Risser vs Rot5 1 4,37 1,097 No ns 10,35 to 19,09 Risser vs follow up 57,79 15,08 Yes *** 71,95 to 43,63 Risser vs Cobb fol up 37,79 9,861 Yes *** 51,95 to 23,63 Significant differences were determined for Risser 0 2 to Cobb t5 t1(p<0.0001)

15 Cobb (<45 ; 45 ) Results 19% 4% Cobb <45 9% 12% Cobb 45 77% 79% correction stabilization progression correction stabilization progression surgery cases surgery cases

16 Cobb (<45 ; 45 ) Results Cobb <45 Cobb 45 Bonferroni's Mean Diff Multiple Comparison Test t P < 0,05? 95% CI of diff Cobb t1 vs Cobb t5 11,46 3,950 Yes * 0,7542 to 22,16 Cobb t5 t1 vs Perd t5 t1 8,099 2,711 No ns 19,12 to 2,923 Age at t1 vs Ct5 t1 23,37 8,103 Yes *** 12,73 to 34,02 Risser vs Ct5 t1 12,50 4,334 Yes ** 1,858 to 23,15 P t1 vs P t5 2,287 0,7928 No ns 8,357 to 12,93 Age at t1 vs Perd t5 t1 15,28 5,140 Yes *** 4,308 to 26,24 Risser vs Perd t5 t1 4,403 1,481 No ns 6,564 to 15,37 Bonferroni's Mean Diff Multiple Comparison Test t P < 0,05? 95% CI of diff Cobb t1 vs Cobb t5 13,74 4,796 Yes *** 3,174 to 24,30 Cobb t5 t1 vs Perd t5 t1 10,31 3,414 No ns 21,45 to 0,8281 Age at t1 vs Ct5 t1 26,38 9,210 Yes *** 15,82 to 36,95 Risser vs Ct5 t1 15,40 5,376 Yes *** 4,838 to 25,97 P t1 vs P t5 4,073 1,422 No ns 6,492 to 14,64 Age at t1 vs Perd t5 t1 20,86 7,119 Yes *** 10,06 to 31,67 Risser vs Perd t5 t1 5,091 1,737 No ns 5,716 to 15,90

17 Pedriolle (<20 ; 20 ) Results 2% 2% Pedriolle <20 Pedriolle 20 16% 96% 27% 57% correction stabilization progression correction stabilization progression surgery cases surgery cases

18 Pedriolle (<20 ; 20 ) Results Pedriolle <20 Pedriolle 20 Bonferroni's Bonferroni's Mean Diff t P < 0,05? 95% CI of diff Mean Diff Multiple Comparison Test Multiple Comparison Test t P < 0,05? 95% CI of diff Cobb t1 vs Cobb t5 16,02 5,630 Yes *** 5,526 to 26,52 Cobb t1 vs Cobb t5 8,400 2,964 No ns 2,057 to 18,86 Cobb t5 t1 vs Perd t5 t1 10,78 3,714 Yes * 21,49 to 0,07732 Cobb t5 t1 vs Perd t5 t1 7,202 2,372 No ns 18,41 to 4,000 Age at t1 vs Ct5 t1 27,96 9,871 Yes *** 17,52 to 38,41 Age at t1 vs Ct5 t1 20,88 7,367 Yes *** 10,42 to 31,33 Risser vs Ct5 t1 16,89 5,963 Yes *** 6,444 to 27,34 Risser vs Ct5 t1 10,10 3,565 No ns 0,3543 to 20,56 P t1 vs P t5 4,094 1,439 No ns 6,401 to 14,59 P t1 vs P t5 1,558 0,5533 No ns 8,831 to 11,95 Age at t1 vs Perd t5 t1 17,18 5,919 Yes *** 6,477 to 27,89 Age at t1 vs Perd t5 t1 13,68 4,690 Yes *** 2,916 to 24,44 Risser vs Perd t5 t1 6,109 2,105 No ns 4,595 to 16,81 Risser vs Perd t5 t1 2,900 0,9945 No ns 7,860 to 13,66

19 Results Subgroups Cobb 50 Degrees T<19 t>20 C>45 10 C<45 15 C M t 5 -t 1 0 t1 t2 t3 t4 t5 30 Perdriolle 10 5 Degrees T<19 t>20 C>45 0 T<19 t>20 C<45 C>45 0 t1 t2 t3 t4 t5 C<45

20 Results Analyses of 28 patients who abandoned the treatment: Cobb was 47,18 a t1 and at t3 with mean correction of Mean age was at t1 and at age of abandon Correction: Stabilization: 23 patients (82%) 4 patients (14%) correction stabilization progression Progression: 1 patients (4%) Only 5 patients have indication to surgery at the time of abandon

21 Discussion Subgroups> surgery cases 82% concluded treatment below 45 13,42 ± 7,415 cobb correction

22 Conclusion The primary aim: The brace treatment confirm its efficacy also in the treatment of scoliotic curves above 40 degree in a prospective study with stabilization (14%) and correction (77%) Surgery indication 15,3% 160 Patients Results 28 in treatment 104 at follow up correc on stabiliza on progression 14% 9% 28 have abandoned treatment correc on stabiliza on progression 14% 4% 77% 82% 16 recommended for surgery 5 recommended for surgery

23 The secondary aim: Conclusion Rotation lower 20 (Perdriolle) Risser between 0-2 2% 2% 96% correction stabilization progression Cobb Degrees t1 t2 t3 t4 t5 T<19

24 Conclusion Results allow to say that an adequate brace treatment must be absolutely considered in the treatment of scoliotic curves above 40 degrees in patients who refuse surgery. Brace treatment should be considered as the first choice to try avoiding fusion if the rotation is lower than 20 and Risser is between 0-2. This approach can reduce the high sanitary and social costs of surgery.

25

26 Conclusion

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