A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
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|ClinicalTrials.gov Identifier: NCT03365804|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2017
Last Update Posted : December 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Device: 3D Printed Brace||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis|
|Estimated Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 3D Printed Brace
This group will receive 3D printed brace
Device: 3D Printed Brace
All subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing.
No Intervention: Traditional Brace
This group will receive the traditional brace
- Evaluate the in-brace Cobb angle on radiograph [ Time Frame: It will be completed 2 months after the last participant is recruited. ]The in-brace Cobb angle will be measured from the radiograph at the first follow-up clinic.
- Evaluate participants' compliance on how they use their braces [ Time Frame: The result can be reported within 6 months after the last participant is recruited. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365804
|Contact: Edmond Lou, PhDfirstname.lastname@example.org|
|Contact: Doug Hill, MBAemail@example.com|
|Principal Investigator:||Edmond Lou, PhD||University of Alberta|