Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth

NCT04904627 | Recruiting

• 1 other identifier: COB-ISICO
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Scoliosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• HRQOL

  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

  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

  after an average period of 4 years +/-2

• Treatment compliance

  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

  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

Study Arms (2)

Polyehtylene vs Poliìycarbonate

super rigid vs rigid material

Free pelvis vs classic pelvis

fixed pelvis versus free pelvis, allowing adjustment in the sagittal plane.

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Scientifico Italiano Colonna Vertebrale: lead

Study Sites (1)

ISICO

Milan, Mi, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 27, 2021
• Study Start: July 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IT (1)