Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression

Idiopathic Scoliosis Clinical Trial

— PRISCOPRO  

Official title:

3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04805437
• Other study ID #: ED-PG-AA-2021-Brace
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: April 2037

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: Elias Diarbakerli, PT, PhD
• Phone: +460851770000
• Email: elias.diarbakerli[@]sll.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.

Description:

Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.

In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.

For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: April 2037
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Cobb 25-40 degrees

• Skeletally immature, Sanders score of 6 or less and Risser 2 or less.

• Menarche status maximum one year in females

• Aged 9-17 years

• No previous brace treatment or surgery for scoliosis

• Apex of the primary curve at T7 or caudal

Exclusion Criteria:

• Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)

• Previous spine surgery

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Device:
• 3D TLSO
Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
• Standard TLSO
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.

Locations

Country	Name	City	State
Sweden	Linköping university hospital	Linköping
Sweden	Karolinska university hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Linkoeping University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Curve progression	Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline	Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.
Secondary	Clinical outcomes	Angle of trunk rotation in forward bending, assessed with scoliometer	At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	Scoliosis Research Society-22r questionnaire	At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	EQ5D questionnaire	At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	Spinal Appearance Questionnaire (SAQ)	At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Secondary	Patient-reported outcome measures	International Physical Activity Questionnaire (IPAQ)	At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Secondary	Surgical rates	Number needing surgical intervention	At each six-months follow-up and 2, 5, 10 years after skeletal maturity