Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth

Istituto Scientifico Italiano Colonna Vertebrale

Status

Enrolling

Conditions

Scoliosis

Study type

Observational

Funder types

Other

Identifiers

NCT04904627

COB-ISICO

Details and patient eligibility

About

The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. Plastic materials have also changed. In addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. In some cases, modular constructions were introduced with respect to the customized one. All this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved.

There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations.

The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.

Enrollment

470 estimated patients

Sex

All

Ages

Under 16 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis,
age under 16 years at the start of observation,
brace prescription for more than 18 hours/day,
availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year.
availability of compliance data
Risser between 0 and 4 at first assessment

Exclusion criteria