ScoliosisNCT04904627
Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth
An observational study of Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial summary
The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Scoliosis
- How many people
- 470 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to Dec 2024
- Phase
- Observational
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Growing subjects suffering from spinal deformity (adolescent idiopathic scoliosis and / or hyperkyphosis) undergoing brace treatment.
Who may be able to join
- Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis,
- age under 16 years at the start of observation,
- brace prescription for more than 18 hours/day,
- availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year.
- availability of compliance data
- Risser between 0 and 4 at first assessment
Who cannot join
- All secondary causes of scoliosis
- history of spinal fusion surgery
- lack of one of the radiographic examinations required by the protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
ISICO
Milan, Mi, 20141
Sabrina Donzelli, MD, 0039 02 84161700, sabrina.donzelli@isico.it
About this study
Official title: Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth: Efficacy Analysis of a Retrospective Cohort
The construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. Plastic materials have also changed. In addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. In some cases, modular constructions were introduced with respect to the customized one. All this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved.
There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations.
The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.
- Conditions
- Scoliosis
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Polyehtylene vs Poliìycarbonate | super rigid vs rigid material | |
| Free pelvis vs classic pelvis | fixed pelvis versus free pelvis, allowing adjustment in the sagittal plane. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in radiographic measurements
variation of Cobb degrees of the main curve in the frontal plane over time
Measured: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
Changes in radiographic measurements
variation of Cobb degrees of all curves in the frontal and sagittal plane over time.
Measured: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
Secondary outcomes (7)
HRQOL
measures of quality of life. The Italian Spine Youth Quality of Life questionnaire (ISYQOL) measures the health-related quality of life of adolescents with spinal deformities. ISYQOL consists of 20 items, each scored 0, 1 or 2. In accordance with the Rasch analysis technique, used to develop the questionnaire, the ordinal ISYQOL total score is converted to an interval measure (i.e., ISYQOL measure), which is expressed on a 0%-100% scale (with 100% indicating high quality of life).
Measured: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
HRQOL
measures of quality of life. The Scoliosis Research Society-22 (SRS-22) is a questionnaire developped to measure health-related quality of life in patients with idiopathic scoliosis. It has 22 questions divided into five domains: function/activity, pain, self-image/appearance, mental health and satisfaction with management. Each domain contains five questions, except the satisfaction with management domain, which contains two questions. Each item can be scored from 1 (worst possible) to 5 (best possible). The function/activity, pain, self-image and mental health domains have a total score ranging from 5 to 25. The satisfaction with management domain has a total score ranging from 2 to 10. The maximum total score is 110 and the results are expressed as a mean
Measured: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
Treatment outcome
variation of the main curve of at least 5 Cobb degrees, end treatment results: main curve </=30 Cobb degrees, main curve </=45 Cobb degrees, and main curve >50 Cobb degrees
Measured: after an average period of 4 years +/-2
Treatment compliance
Treatment compliance measures: percentage of brace wearing declared and measured by heat sensors
Measured: after a month from the start of brace wearing, after 5 ± 2 months, and after an average period of 4 years +/-2
Deformity clinical measures
score on the evaluation of the aesthetic profile of the trunk (TRACE)
Measured: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Deformity clinical measures
measurement of the hump on the Adams test in degrees
Measured: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Deformity clinical measures
measurement of the hump on the Adams test in millimeters
Measured: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jul 2021
- Primary completion1 Dec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904627
- Sponsor's protocol ID
- COB-ISICO
- Status last verified
- May 2024
- First submitted
- 12 May 2021
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constructive Variations of Classic Orthopedic Braces for Spinal Deformity During Growth: Efficacy Analysis of a Retrospective Cohort
- ClinicalTrials.gov ID
- NCT04904627
- Acronym / sponsor ID
- COB-ISICO
- Conditions
- Scoliosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 May 2021 (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 construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. The closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. Plastic materials have also changed. In addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. In some cases, modular constructions were introduced with respect to the customized one. All this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved.
There are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations.
The purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyehtylene vs Poliìycarbonate | – | –super rigid vs rigid material |
| Free pelvis vs classic pelvis | – | –fixed pelvis versus free pelvis, allowing adjustment in the sagittal plane. |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Growing subjects suffering from spinal deformity (adolescent idiopathic scoliosis and / or hyperkyphosis) undergoing brace treatment.
Key inclusion criteria (6 listed)
- Idiopathic adolescent scoliosis and/or dorsal hyperkyphosis,
- age under 16 years at the start of observation,
- brace prescription for more than 18 hours/day,
- availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year.
- availability of compliance data
Key exclusion criteria (3 listed)
- All secondary causes of scoliosis
- history of spinal fusion surgery
- lack of one of the radiographic examinations required by the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in radiographic measurements
Time frame: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
variation of Cobb degrees of the main curve in the frontal plane over time
Changes in radiographic measurements
Time frame: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.
variation of Cobb degrees of all curves in the frontal and sagittal plane over time.
7 secondary outcomes
HRQOL
Time frame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
HRQOL
Time frame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months, after an average period of 4 years +/-2 , and 1 year later
Treatment outcome
Time frame: after an average period of 4 years +/-2
Treatment compliance
Time frame: after a month from the start of brace wearing, after 5 ± 2 months, and after an average period of 4 years +/-2
Deformity clinical measures
Time frame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Deformity clinical measures
Time frame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Deformity clinical measures
Time frame: pre-treatment, after a month from the start of brace wearing, after 5 ± 2 months,after an average period of 4 years +/-2 , and 1 year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by Istituto Scientifico Italiano Colonna Vertebrale 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: status not confirmed, as of the sponsor's last update on 8 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in radiographic measurements (time frame: pre-treatment, in brace after a month from the start of wearing and without brace after 5 ± 2 months, after an average period of 4 years +/-2 , after 48 hours without brace and 1 year later.). The study lists 2 primary outcomes in all. 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 8 May 2024.