Clinical trial NCT04904627: Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
Official title: Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth: Efficacy Analysis of a Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scoliosis
Lead sponsor: Istituto Scientifico Italiano Colonna Vertebrale
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 470
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Growing subjects suffering from spinal deformity (adolescent idiopathic scoliosis and / or hyperkyphosis) undergoing brace treatment.

Brief summary: 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.


Eligibility criteria: 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:

* All secondary causes of scoliosis
* history of spinal fusion surgery
* lack of one of the radiographic examinations required by the protocol

Primary outcomes:
measure: Changes in radiographic measurements
timeFrame: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
measure: Changes in radiographic measurements
timeFrame: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
Secondary outcomes:
measure: HRQOL
timeFrame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
measure: HRQOL
timeFrame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
measure: Treatment outcome
timeFrame: after an average period of 4 years +/-2
measure: Treatment compliance
timeFrame: after a month from the start of brace wearing, after 5 ± 2 months, and after an average period of 4 years +/-2
measure: Deformity clinical measures
timeFrame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
measure: Deformity clinical measures
timeFrame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
measure: Deformity clinical measures
timeFrame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ISICO
state: Mi
Study officials:
References: