Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth

Scoliosis Clinical Trial

Official title:

Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth: Efficacy Analysis of a Retrospective Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904627
• Other study ID #: COB-ISICO
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Istituto Scientifico Italiano Colonna Vertebrale
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 470
• Est. completion date: December 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Scoliosis

Locations

Country	Name	City	State
Italy	ISICO	Milan	Mi

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Italiano Colonna Vertebrale

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in radiographic measurements	variation of Cobb degrees of the main curve in the frontal plane over time	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.
Primary	Changes in radiographic measurements	variation of Cobb degrees of all curves in the frontal and sagittal plane over time.	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	HRQOL	measures of quality of life. The Italian Spine Youth Quality of Life questionnaire (ISYQOL) measures the health-related quality of life of adolescents with spinal deformities. ISYQOL consists of 20 items, each scored 0, 1 or 2. In accordance with the Rasch analysis technique, used to develop the questionnaire, the ordinal ISYQOL total score is converted to an interval measure (i.e., ISYQOL measure), which is expressed on a 0%-100% scale (with 100% indicating high quality of life).	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
Secondary	HRQOL	measures of quality of life. The Scoliosis Research Society-22 (SRS-22) is a questionnaire developped to measure health-related quality of life in patients with idiopathic scoliosis. It has 22 questions divided into five domains: function/activity, pain, self-image/appearance, mental health and satisfaction with management. Each domain contains five questions, except the satisfaction with management domain, which contains two questions. Each item can be scored from 1 (worst possible) to 5 (best possible). The function/activity, pain, self-image and mental health domains have a total score ranging from 5 to 25. The satisfaction with management domain has a total score ranging from 2 to 10. The maximum total score is 110 and the results are expressed as a mean	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
Secondary	Treatment outcome	variation of the main curve of at least 5 Cobb degrees, end treatment results: main curve	after an average period of 4 years +/-2
Secondary	Treatment compliance	Treatment compliance measures: percentage of brace wearing declared and measured by heat sensors	after a month from the start of brace wearing, after 5 ± 2 months, and after an average period of 4 years +/-2
Secondary	Deformity clinical measures	score on the evaluation of the aesthetic profile of the trunk (TRACE)	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
Secondary	Deformity clinical measures	measurement of the hump on the Adams test in degrees	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
Secondary	Deformity clinical measures	measurement of the hump on the Adams test in millimeters	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