NCT05001568

Brief Summary

Adolescent Idiopathic Scoliosis affects 3-4% of the Canadian population, of which about 10% will need a brace treatment during pubertal growth spurt. Our team has developed an innovative conception method for brace design by optimizing for the immediate in-brace correction. The model is customized to each patient. In this project, the investigators will evaluate the effectiveness of this platform's customized treatment and validate its clinical application.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

July 27, 2021

Last Update Submit

January 19, 2024

Conditions

ScoliosisIdiopathic Scoliosis

Keywords

ScoliosisSpine deformityNighttime braceOptimization

Outcome Measures

Primary Outcomes (1)

  • Change in Cobb angle

    Radiographics will be gathered and analyzed to observe changes between time points. All out-of-brace radiographs will be taken with an low-dose biplane radiographic system (EOS) to allow 3D reconstructions.

    Baseline, 1 year, 2 years

Secondary Outcomes (4)

  • Treatment failure rate

    Baseline, 1 year, 2 years

  • Quality of Life (QoL) - SRS-22r

    Baseline, 1 year, 2 years

  • Quality of Life (QoL) - MOBI

    1 year, 2 years

  • Immediate in-brace Cobb angle

    5 minutes after brace fitting

Study Arms (2)

Optimized Providence brace

EXPERIMENTAL

The braces will be designed using optimization and finite element analysis.

Device: Immediate in-brace correction: Conventional BraceDevice: Immediate in-brace correction: Optimized BraceDevice: Long-term bracing: Optimized Brace

Conventional Providence brace

ACTIVE COMPARATOR

The braces will be designed by an orthotist using the conventional design method.

Device: Immediate in-brace correction: Conventional BraceDevice: Immediate in-brace correction: Optimized BraceDevice: Long-term bracing: Conventional Brace

Interventions

Immediate in-brace correction: Conventional BraceDEVICE

The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.

Conventional Providence braceOptimized Providence brace
Immediate in-brace correction: Optimized BraceDEVICE

The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.

Conventional Providence braceOptimized Providence brace
Long-term bracing: Conventional BraceDEVICE

After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.

Conventional Providence brace
Long-term bracing: Optimized BraceDEVICE

After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.

Optimized Providence brace

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • AIS diagnosis
  • Risser 0-2
  • Primary curve angles 20 degrees - 40 degrees
  • If female, either premenarchal or less than 18 months postmenarchal.

You may not qualify if:

  • Patients with a pre-existing cardiovascular condition
  • Patients with a symptom of a neurological disorder
  • Patients with any other disorder of the musculoskeletal system affecting the lower limbs
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

  • Coulombe M, Guy A, Barchi S, Labelle H, Aubin CE. Optimized braces for the treatment of adolescent idiopathic scoliosis: A study protocol of a prospective randomised controlled trial. PLoS One. 2024 Feb 7;19(2):e0292069. doi: 10.1371/journal.pone.0292069. eCollection 2024.

    PMID: 38324512DERIVED

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will be separated into two stages. Each patient will initially try a control brace and a test brace in a crossover study model to evaluate the immediate correction. Each patient will then use one brace from either the control arm or test arm to evaluate the long-term correction of the brace.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedist, researcher

Study Record Dates

First Submitted

July 27, 2021

First Posted

August 12, 2021

Study Start

November 15, 2021

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations

CA(1)