Adolescent Idiopathic ScoliosisNCT04282408
Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
A study testing Scoliosis back brace in people with Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta). The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis, Osteogenesis Imperfecta
- What is being tested?
- Scoliosis back brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 9 Jul 2019to 31 May 2021
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ages 6 to 17 years;
- lumbar or thoracolumbar scoliosis;
- measured rib hump greater than 5 degrees with scoliometer;
- Cobb angle, measured on frontal X-ray images, within 15 and 30 degrees.
- ages 3 to 17 years;
- vertebral pain and/or vertebral deformity with typical double-concave lenses shape and/or deformity in frontal or sagittal planes assessed with clinical traction, deflection or derotational tests.
Who cannot join
- skin allergies;
- behavioural and psychiatric problems (e.g., emotional problems, anxiety, panic);
- chest dimensions beyond printing limits (i.e., maximum diameter 35 cm and maximum height 60 cm).
Trial locations and contacts
1 site in 1 country.
About this study
The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta).
The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
- Being tested
- Scoliosis back brace
- Keywords
- scoliosis, spinal deformity
- Medical subject headings
- Osteogenesis Imperfecta, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoliosis back braceDevice
The patients will use the traditional brace, if not already in use, for 2 weeks and then they will wear a 3D printed back brace for the following 2 weeks. Both the braces will be worn for the amount of hours per day prescribed by the physician.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Group treated with 3D printed brace Receives: Device: Scoliosis back brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comfort and safety evaluation by using surveys
The patients have to fill in ad hoc surveys with open and closed questions about their personal experience with the traditional brace only and after the use of the 3D printed brace. In the closed questions they will have to mark a score from 1 to 7, where higher values correspond to better outcome.
Measured: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.
Secondary outcomes (4)
Production process time evaluation
The innovative process will be analysed by recording the time for each phase, from the geometry acquisition with 3D scanning to the delivery of the final 3D printed brace.
Measured: The design and manufacturing will take place in the first 2 weeks between the first and the second visit.
Material amount evaluation
The production process will be also analyzed in term of amount of material used: both for the final product and for the part wasted in building supports.
Measured: The meaasurements will take place immediately after the brace is removed from the printer and right before delivering the brace to the patient in its final layout.
Stability assessment with and without braces measured by sway area
Data are collected with an inertial sensor while performing the following task: maintaining a static standing position for 1 minute (3 repetitions), both with and without the braces.
Measured: After 2 weeks of treatment with the 3D printed brace.
Gait symmetry metric with and without braces
Data are collected with an inertial sensor while performing the following task: Timed Up and Go (TUG) test (3 repetitions).
Measured: After 2 weeks of treatment with the 3D printed brace.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start9 Jul 2019
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Italy - IPCB, Orthopedic Center "Biomedica Su Misura" (Brescia, Italy), Orthopedic Center "Labsan" (Lecco, Italy), Politecnico di Milano - DIG Department
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282408
- Sponsor's protocol ID
- GIP673
- Status last verified
- Mar 2022
- First submitted
- 11 Feb 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Costantini S, Redaelli DF, Fraschini P, Biffi E, Storm FA. On mobility and gait in scoliosis patients: a comparison of conventional and 3D-printed braces during an instrumented timed-up and go test. BMC Musculoskelet Disord. 2025 Jan 27;26(1):86. doi: 10.1186/s12891-025-08311-w.
PubMed 39871223
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Evaluation of Back Braces for the Treatment of Spinal Deformity Produced With 3D Printing Technology
- ClinicalTrials.gov ID
- NCT04282408
- Acronym / sponsor ID
- GIP673
- Keywords
- scoliosis, spinal deformity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- National Research Council of Italy - IPCB, Orthopedic Center "Biomedica Su Misura" (Brescia, Italy), Orthopedic Center "Labsan" (Lecco, Italy), Politecnico di Milano - DIG Department
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 24 Feb 2020 (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.
The proposed investigation is a pilot study that involves pediatric patients affected by spinal deformity (Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta).
The main goal is to evaluate the acceptability, the safety and the overall satisfaction of the patients wearing the back braces produced with an innovative methodology using 3D printers, compared to the current braces manufactured with a production model based on thermoforming, that has well-established clinical efficacy.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Scoliosis back braceGroup treated with 3D printed brace |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- ages 6 to 17 years;
- lumbar or thoracolumbar scoliosis;
- measured rib hump greater than 5 degrees with scoliometer;
- Cobb angle, measured on frontal X-ray images, within 15 and 30 degrees.
- ages 3 to 17 years;
Key exclusion criteria (3 listed)
- skin allergies;
- behavioural and psychiatric problems (e.g., emotional problems, anxiety, panic);
- chest dimensions beyond printing limits (i.e., maximum diameter 35 cm and maximum height 60 cm).
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 |
|---|---|---|
| Scoliosis back braceThe patients will use the traditional brace, if not already in use, for 2 weeks and then they will wear a 3D printed back brace for the following 2 weeks. Both the braces will be worn for the amount of hours per day prescribed by the physician. | Device | Treatment |
Primary outcome
Comfort and safety evaluation by using surveys
Time frame: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.
The patients have to fill in ad hoc surveys with open and closed questions about their personal experience with the traditional brace only and after the use of the 3D printed brace. In the closed questions they will have to mark a score from 1 to 7, where higher values correspond to better outcome.
4 secondary outcomes
Production process time evaluation
Time frame: The design and manufacturing will take place in the first 2 weeks between the first and the second visit.
Material amount evaluation
Time frame: The meaasurements will take place immediately after the brace is removed from the printer and right before delivering the brace to the patient in its final layout.
Stability assessment with and without braces measured by sway area
Time frame: After 2 weeks of treatment with the 3D printed brace.
Gait symmetry metric with and without braces
Time frame: After 2 weeks of treatment with the 3D printed brace.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Derived from this study: PubMed 39871223Costantini S, Redaelli DF, Fraschini P, Biffi E, Storm FA. On mobility and gait in scoliosis patients: a comparison of conventional and 3D-printed braces during an instrumented timed-up and go test. BMC Musculoskelet Disord. 2025 Jan 27;26(1):86. doi: 10.1186/s12891-025-08311-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scoliosis back brace in people with Adolescent Idiopathic Scoliosis and Osteogenesis Imperfecta, run by IRCCS Eugenio Medea at 1 site in Italy.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 31 Mar 2022. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comfort and safety evaluation by using surveys (time frame: Comparison between traditional and 3D printed brace after 2 weeks of usage of each.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282408, which also lists 1 linked publication.
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 31 Mar 2022.