Monia Lusini1, Sabrina Donzelli1, Salvatore Minnella1, Fabio Zaina1, Stefano Negrini2. 1. ISICO (Italian Scientific Spine Institute), ia Roberto Bellarmino 13/1, 20148, Milan, Italy. 2. Physical and Rehabilitation Medicine, Department of Clinical and Experimental Sciences, University of Brescia, Viale Europa 11, 25123, Brescia, Italy; Department of Clinical and Experimental Sciences, University of Brescia, Viale Europa 11, 25123, Brescia, Italy; IRCCS Don Gnocchi Foundation, Piazzale Morandi 6, 20121, Milan, Italy. Electronic address: stefano.negrini@med.unibs.it.
Abstract
BACKGROUND CONTEXT: Recently, positive results in bracing patients with idiopathic scoliosis (IS) above 45° who refused surgery have been presented in a retrospective study. Obviously, this can give only an efficacy (EA) analysis, as there is neither a control group, nor it is possible to know failures because of dropouts. PURPOSE: To present the prospective results of bracing patients affected by IS above 45° and still growing. STUDY DESIGN: Prospective study including all IS patients with 45° or more, Risser stage 0 to 4, who had their first evaluation in our institute, an outpatient clinic specialized in scoliosis evaluation and conservative treatment, from March 1, 2003 to December 21, 2010 and utterly denied any surgical intervention. PATIENT SAMPLE: Of 59 patients, we excluded 2 patients still in treatment and 57 (11 males) patients were included. At the beginning of the study, they were 15 years 3±22 months of age, had 52.5° Cobb (range, 45°-93°), and Risser 2 (0-4). Thirty-nine accepted a full-time brace treatment (BG) to try avoiding surgery, 18 refused any treatment and served as controls (CG). OUTCOME MEASURES: Physiological measures: radiographic and clinical data. METHODS: Treatment: A year of full-time Sforzesco brace (23 hours/day) or Risser cast (8-12 months) and gradual weaning after Risser 3; all patients performed exercises; and International Society on Scoliosis Orthopaedic and Rehabilitation TREATMENT management criteria were respected. Analyses: EA in patients who completed treatment/observation (34 in BG and 10 in CG) and intent-to-treat (ITT) with worst case analysis in the whole population. Relative risk (RR) and 95% confidence interval (CI) have been computed. RESULTS: Efficacy: failures were 23.5% in BG and 100% in CG. Intent-to-treat: failures were 20.5% in BG and 55.6% in CG. Relative risks of failure in CG were 4.3 (95% CI, 3.6-4.9) in EA and 2.7 (95% CI, 2.0-3.5) in ITT (p<.05). Percentage of patients (53.8%) improved: RRs of improvement in BG were 1.6 (95% CI, 1.46-1.9) in EA and 1.9 (95% CI, 1.6-2.2) in ITT (p<.05). Patients who joined the treatment achieved a 10.4°±10.7° Cobb improvement, an ATR reduction of 4.2°±4.3°, and an esthetic improvement of 2.8±1.9 of 12 points (TRACE). At the end, in BG, 24 patients were below 45° and 6 patients below 35°. CONCLUSIONS: Through this study we can conclude that the conservative brace plus exercises treatment (if correctly performed and managed) is a suitable alternative for those patients who reject any surgical intervention for IS above 45°. But we could also conclude that a good brace treatment should be considered as the first choice to try avoiding fusion because of the high sanitary and social costs of surgery.
BACKGROUND CONTEXT: Recently, positive results in bracing patients with idiopathic scoliosis (IS) above 45° who refused surgery have been presented in a retrospective study. Obviously, this can give only an efficacy (EA) analysis, as there is neither a control group, nor it is possible to know failures because of dropouts. PURPOSE: To present the prospective results of bracing patients affected by IS above 45° and still growing. STUDY DESIGN: Prospective study including all IS patients with 45° or more, Risser stage 0 to 4, who had their first evaluation in our institute, an outpatient clinic specialized in scoliosis evaluation and conservative treatment, from March 1, 2003 to December 21, 2010 and utterly denied any surgical intervention. PATIENT SAMPLE: Of 59 patients, we excluded 2 patients still in treatment and 57 (11 males) patients were included. At the beginning of the study, they were 15 years 3±22 months of age, had 52.5° Cobb (range, 45°-93°), and Risser 2 (0-4). Thirty-nine accepted a full-time brace treatment (BG) to try avoiding surgery, 18 refused any treatment and served as controls (CG). OUTCOME MEASURES: Physiological measures: radiographic and clinical data. METHODS: Treatment: A year of full-time Sforzesco brace (23 hours/day) or Risser cast (8-12 months) and gradual weaning after Risser 3; all patients performed exercises; and International Society on Scoliosis Orthopaedic and Rehabilitation TREATMENT management criteria were respected. Analyses: EA in patients who completed treatment/observation (34 in BG and 10 in CG) and intent-to-treat (ITT) with worst case analysis in the whole population. Relative risk (RR) and 95% confidence interval (CI) have been computed. RESULTS: Efficacy: failures were 23.5% in BG and 100% in CG. Intent-to-treat: failures were 20.5% in BG and 55.6% in CG. Relative risks of failure in CG were 4.3 (95% CI, 3.6-4.9) in EA and 2.7 (95% CI, 2.0-3.5) in ITT (p<.05). Percentage of patients (53.8%) improved: RRs of improvement in BG were 1.6 (95% CI, 1.46-1.9) in EA and 1.9 (95% CI, 1.6-2.2) in ITT (p<.05). Patients who joined the treatment achieved a 10.4°±10.7° Cobb improvement, an ATR reduction of 4.2°±4.3°, and an esthetic improvement of 2.8±1.9 of 12 points (TRACE). At the end, in BG, 24 patients were below 45° and 6 patients below 35°. CONCLUSIONS: Through this study we can conclude that the conservative brace plus exercises treatment (if correctly performed and managed) is a suitable alternative for those patients who reject any surgical intervention for IS above 45°. But we could also conclude that a good brace treatment should be considered as the first choice to try avoiding fusion because of the high sanitary and social costs of surgery.
Authors: Stefano Negrini; Angelo Gabriele Aulisa; Pavel Cerny; Jean Claude de Mauroy; Jeb McAviney; Andrew Mills; Sabrina Donzelli; Theodoros B Grivas; M Timothy Hresko; Tomasz Kotwicki; Hubert Labelle; Louise Marcotte; Martin Matthews; Joe O'Brien; Eric C Parent; Nigel Price; Rigo Manuel; Luke Stikeleather; Michael G Vitale; Man Sang Wong; Grant Wood; James Wynne; Fabio Zaina; Marco Brayda Bruno; Suncica Bulat Würsching; Caglar Yilgor; Patrick Cahill; Eugenio Dema; Patrick Knott; Andrea Lebel; Grigorii Lein; Peter O Newton; Brian G Smith Journal: Eur Spine J Date: 2022-02-21 Impact factor: 3.134
Authors: Stefano Negrini; Fabrizio Tessadri; Francesco Negrini; Marta Tavernaro; Andrea Zonta; Fabio Zaina; Sabrina Donzelli Journal: Children (Basel) Date: 2022-06-11
Authors: Fabio Zaina; Michele Romano; Patrick Knott; Jean Claude de Mauroy; Theodoros B Grivas; Tomasz Kotwicki; Toru Maruyama; Joseph O'Brien; Manuel Rigo; Stefano Negrini Journal: Scoliosis Date: 2015-07-11