Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth

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

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.

Study Overview

• Status: Recruiting
• Conditions: Scoliosis

• Study Type: Observational
• Enrollment (Anticipated): 470

Contacts and Locations

Study Locations

• Italy
  • Mi
    • Milan, Mi, Italy, 20141
      • Recruiting
      • ISICO
      • Contact: Sabrina Donzelli, MD; Phone Number: 0039 02 84161700; Email: sabrina.donzelli@isico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Growing subjects suffering from spinal deformity (adolescent idiopathic scoliosis and / or hyperkyphosis) undergoing brace treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Polyehtylene vs Poliìycarbonate; super rigid vs rigid material
Free pelvis vs classic pelvis; fixed pelvis versus free pelvis, allowing adjustment in the sagittal plane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Treatment outcome	variation of the main curve of at least 5 Cobb degrees, end treatment results: main curve </=30 Cobb degrees, main curve </=45 Cobb degrees, and main curve >50 Cobb degrees	after an average period of 4 years +/-2
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 24, 2021
• First Posted (Actual): May 27, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: COB-ISICO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No