A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
Primary Purpose
Adolescent Idiopathic Scoliosis
Status
Suspended
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
3D Printed Brace
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Idiopathic Scoliosis focused on measuring Ultrasound, Scoliosis, Orthoses, 3D Printing
Eligibility Criteria
Inclusion Criteria:
It is based on the standard SRS brace studies criteria: a) diagnosed with AIS and new to rigid spinal brace treatment, b) prescribed full-time brace wear (23 hours per day), c) primary Cobb angles 20°- 40°, d) age between 10 -16 years, e) Risser 0-2 (skeletally immature), f) if female either premenarchal or less than 1 year postmenarchal.
Exclusion Criteria:
- no surgery
Sites / Locations
- Stollery Children hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
3D Printed Brace
Traditional Brace
Arm Description
This group will receive 3D printed brace
This group will receive the traditional brace
Outcomes
Primary Outcome Measures
Evaluate the in-brace Cobb angle on radiograph
The in-brace Cobb angle will be measured from the radiograph at the first follow-up clinic.
Secondary Outcome Measures
Evaluate participants' compliance on how they use their braces
The data inside the brace monitors will be downloaded at each clinic visit to understand how well the participants use their brace. The time and wear tightness are the 2 parameters to be evaluated.
Full Information
NCT ID
NCT03365804
First Posted
December 2, 2017
Last Updated
May 23, 2023
Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
1. Study Identification
Unique Protocol Identification Number
NCT03365804
Brief Title
A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
Official Title
A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Suspended
Why Stopped
COVID-19 Pandemic
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Women and Children's Health Research Institute, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine due to an unknown cause. Bracing is a proven non-surgical treatment for scoliosis. Our group developed an ultrasound assisted method which can improve brace design. However, it is still quite time consuming to construct a brace. Although 3D printing technology has been proposed to construct a scoliosis brace, its effectiveness has not been validated. The goals of this study was to investigate if an effective and comfortable brace can be designed and fabricated by using ultrasound and computer-aided design and computer-aided manufacturing (CAD/CAM) technology, and be printed directly from a 3D printer with faster production, lower cost, and improved comfort to patients. Also, to investigate the effectiveness of new designed brace. The final outcomes may reduce the total number of spinal surgeries for scoliosis. The benefits not only reduce the health care cost, but also increase the quality of life of these adolescent patients.
Detailed Description
A randomized clinical trial with a total of 50 new brace candidates diagnosed with AIS from the Stollery Children's Hospital Scoliosis Clinic will be conducted in the next 2 years. Ethics approval (Pro00054113) has been granted. Inclusion is based on the standard Scoliosis Research Society (SRS) brace studies criteria: a) diagnosed with AIS and new to rigid spinal brace treatment, b) prescribed full-time brace wear (23 hours per day), c) primary Cobb angles 20°- 40°, d) age between 10 -16 years, e) Risser 0-2 (skeletally immature), f) either premenarchal or less than 1 year postmenarchal. The 50 subjects will be randomly assigned to 2 equally sized groups (n=25 in each group): group A conventional designed and manual fabricated braces and group B ultrasound and CAD/CAM scanner designed brace with printing by a 3D printer.
Both groups: A brace monitor (2.5cm x 4.0cm x 1.5 cm and 8g) developed from our group will be installed into all braces for both study groups. It will monitor patients' compliance which includes how much time they use their braces and how much time they wear their braces at the prescribed tightness level (quantity and quality). The battery power and memory capacities of the monitor last for 9 months with the sample rate at 1 sample/minute. The brace monitor will be embedded into the brace). No extra attention is needed from the patients. The brace wear pattern data will be downloaded at the routinely scheduled follow up clinics (post brace prescription of 2 months, 6 months, 1 year and every 6 months periods).
For the compliance assessment, we will get 80% power in this sample size if the average compliance from the control group is 60±4% (from our previous study), but in the intervention group the compliance is increased to 70±4%. The compliance is the number of brace wear hours relative to the prescribed hours per day wear time.
Outcomes: When subjects return to their regular follow up scoliosis clinics, the standard standing in-brace radiographs will be taken. The in-brace Cobb angle will be measured by the clinic staff and saved into the clinical database. The Cobb angle correction (in percent) of the treated curve as measured at the immediate follow-up clinic (in-brace radiographic clinic) [(Pre-Out of brace Cobb angle - In-brace Cobb angle)/Pre-brace Cobb angle]*100 will be used to evaluate the immediate effectiveness. An unpaired 2-tailed Student's t-test using an alpha of 0.05 will be used to compare the correction observed in the intervention group to that of the control group. The total numbers of in-brace radiographs will be tailed; it will be counted up to the last radiograph that shows an in-brace correction which is deemed acceptable by the attending orthopedic surgeon. The number of radiographs will be compared between the two study groups. The p-value of the chi-squared test for independence will be used to determine whether a statistically significant difference exists between the 2 groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis
Keywords
Ultrasound, Scoliosis, Orthoses, 3D Printing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D Printed Brace
Arm Type
Experimental
Arm Description
This group will receive 3D printed brace
Arm Title
Traditional Brace
Arm Type
No Intervention
Arm Description
This group will receive the traditional brace
Intervention Type
Device
Intervention Name(s)
3D Printed Brace
Intervention Description
All subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing.
Primary Outcome Measure Information:
Title
Evaluate the in-brace Cobb angle on radiograph
Description
The in-brace Cobb angle will be measured from the radiograph at the first follow-up clinic.
Time Frame
It will be completed 2 months after the last participant is recruited.
Secondary Outcome Measure Information:
Title
Evaluate participants' compliance on how they use their braces
Description
The data inside the brace monitors will be downloaded at each clinic visit to understand how well the participants use their brace. The time and wear tightness are the 2 parameters to be evaluated.
Time Frame
The result can be reported within 6 months after the last participant is recruited.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
It is based on the standard SRS brace studies criteria: a) diagnosed with AIS and new to rigid spinal brace treatment, b) prescribed full-time brace wear (23 hours per day), c) primary Cobb angles 20°- 40°, d) age between 10 -16 years, e) Risser 0-2 (skeletally immature), f) if female either premenarchal or less than 1 year postmenarchal.
Exclusion Criteria:
no surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmond Lou, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stollery Children hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2B7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
We'll reach out to this number within 24 hrs