Determining Best Indications for Bracing for Adolescent Idiopathic Scoliosis

NCT04117334 | Recruiting

• 1 other identifier: PB version 1.0
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective study for Investigating the cost-effectiveness of current bracing protocols for adolescent idiopathic scoliosis (AIS). It is hypothesized that aggressive management of adolescent idiopathic scoliosis (AIS) including early bracing at mild curve magnitudes and surgery at 40 degrees is more cost-effective while maintaining similar health quality of life. Scoliosis Research Society 22-item and EuroQol- 5 dimension questionnaires and direct/indirect medical costs will be utilized for the cost-effectiveness analysis and health related quality of life assessment. The findings of this study have the potential to improve decision-making and revolutionize care of AIS patients in Hong Kong and globally. Clinicians will be able to utilize our results to provide the best and most cost-effective timing for initiating brace treatment.

Conditions

Adolescent Idiopathic Scoliosis

Keywords

Bracing; Cost-effectiveness; Adolescent idiopathic scoliosis

Outcome Measures

Primary Outcomes (8)

• Change in Cobb angle

  Cobb angle changes from final visit as compared to baseline

  up to 3 years

• Cost-effectiveness of bracing - direct and indirect costs

  Costs involve number of clinic follow-up, any form of outpatient and inpatient treatment (including physiotherapy, scoliosis specific exercises, bracing) and complications. Unit cost of investigation, treatment and follow-up. These will be analyzed against the benefits of bracing on clinical parameters, that is, any deterioration of Cobb angle

  up to 3 years

• Change in C7-CSVL

  Changes in C7-central sacral vertical line with brace follow-up

  up to 3 years

• Change in truncal shift

  Changes in truncal shift with brace follow-up

  up to 3 years

• Change in sagittal vertical axis

  Change sagittal vertical axis with brace follow-up

  up to 3 years

• Change in thoracic kyphosis

  Change in thoracic kyphosis with brace follow-up

  up to 3 years

• Change in lumbar lordosis

  Change in lumbar lordosis with brace follow-up

  up to 3 years

• Change in rotational profile

  Change in 3D parameters/apical rotation with brace follow-up

  up to 3 years

Secondary Outcomes (3)

• Patient's quality of life - SRS-22r

  up to 3 years

• Patient's quality of life - EQ5DY

  up to 3 years

• Brace compliance

  up to 3 years

Study Arms (1)

Bracing AIS patients

These are patients undergoing brace treatment for AIS

Other: Bracing

Interventions

Bracing OTHER

Bracing AIS patients

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective cohort of AIS patients who are newly prescribed with bracing treatment

You may qualify if:

• Patients who are diagnosed with adolescent idiopathic scoliosis and are seen in the first setting with remaining growth potential (Risser 0-2), and are prescribed with either underarm (Boston) or Milwaukee bracing

You may not qualify if:

• Patients whose diagnosis is not adolescent idiopathic scoliosis, unable to comply with study follow-up and refused consent for study

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Duchess of Kent Children's Hospital

Hong Kong, Hong Kong

RECRUITING

Jason Pui Yin Cheung

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

Braces

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Jason Cheung, MBBS, MS

  HKU/HA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Cheung, MBBS, MS

CONTACT

(852)22554581; cheungjp@hku.hk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 7, 2019
• Study Start: December 1, 2016
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 6, 2024

Record last verified: 2024-11

Locations

HK (2)