Adolescent Idiopathic ScoliosisNCT03365804
A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
A study testing 3D Printed Brace in people with Adolescent Idiopathic Scoliosis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- 3D Printed Brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- no surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- 3D Printed Brace
- Keywords
- Ultrasound, Scoliosis, Orthoses, 3D Printing
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Printed BraceDevice
All subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing.
| Study group | Role | What they receive |
|---|---|---|
| 3D Printed Brace | Experimental | This group will receive 3D printed brace Receives: Device: 3D Printed Brace |
| Traditional Brace | No intervention | This group will receive the traditional brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be completed 2 months after the last participant is recruited.
Secondary outcomes (1)
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.
Measured: The result can be reported within 6 months after the last participant is recruited.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: COVID-19 Pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Responsible party
- Sponsor
- Investigators
- Edmond Lou, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365804
- Sponsor's protocol ID
- Pro00054113
- Status last verified
- Jun 2024
- First submitted
- 2 Dec 2017
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Spinal Brace Design Concept for the Treatment of Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT03365804
- Acronym / sponsor ID
- Pro00054113
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- Ultrasound, Scoliosis, Orthoses, 3D Printing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 Pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Women and Children's Health Research Institute, Canada
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Printed Brace | Experimental | Device: 3D Printed BraceThis group will receive 3D printed brace |
| Traditional Brace | No intervention | –This group will receive the traditional brace |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- no surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Printed BraceAll subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing. | Device | 3D Printed Brace |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edmond Lou, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D Printed Brace in people with Adolescent Idiopathic Scoliosis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 Pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the in-brace Cobb angle on radiograph (time frame: It will be completed 2 months after the last participant is recruited.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.