Hyperkyphosis, AdolescentNCT04924556
The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis
An observational study of Hyperkyphosis, Adolescent and Scheuermann Disease, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Hyperkyphosis, Adolescent, Scheuermann Disease, Spinal Curvatures
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Mar 2021to 16 Aug 2021
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 10-18 years patients with Scheuermann's kyphosis or adolescent hyperkyphosis and treated with CAD-CAM design a rigid brace
Who may be able to join
- Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis.
- Inıtial curve magnitude between 55-75°
- Patients who followed up at least 6 months
- Patients who wearing CAD-CAM (Computer-Aided Design\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more
Who cannot join
- History of spinal surgery or trauma
- Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes
- Ankylosing spondylitis and other spondyloarthropathies.
- The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Formed Healthcare Scoliosis Treatment and Brace Center
Istanbul, İ̇stanbul, 34384
Ahsen Büyükaslan, MSc., 05336992960, ahsen.buyukaslan@gmail.com
About this study
This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.
- Keywords
- Scheuermann Disease, Adolescent Hyperkyphosis, Sagittal Balance, Spinopelvic Parameters
- Medical subject headings
- Scheuermann Disease, Spinal Curvatures
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from kyphosis angle at 6 months
Change from Baseline kyphosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure between T4-T12 vertebra.
Measured: 6 months after from beginning of study
Change from lordosis angle at 6 months
Change from Baseline lordosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure from the L1-S1 and L4-S1 levels of the vertebra.
Measured: 6 months after from beginning of study
Change from the global tilt at 6 months
Change from Baseline global tilt(degree) in standing full-length lateral digital radiographs at 6 months. The global tilt is the sum of the C7 vertical tilt and the pelvic tilt.
Measured: 6 months after from beginning of study
Change from Global Alignment and Proportion (GAP) score at 6 months
GAP score is a new pelvic incidence-based proportional method to analyze sagittal alignment and balance, developed by the European Spine Study Group (ESSG). The GAP score evaluates the disproportion, magnitude and distribution of lumbar lordosis, and the global spinopelvic alignment proportionally rather than an absolute numerical value when compared to the ideal calculated for any individual. GAP score has five domains including relative pelvic version, relative lumbar lordosis, lordosis distribution index, relative spinopelvic alignment, and age factor. Scores of each of the four domains vary between 0 to 3 and age factor domain varies between 0 to 1. The total GAP score is between 0 and 13 points and obtained by adding the scores of these five domains. If the total score was 0 to 2, alignment accepted as proportional; 3 to 6 as moderate malalignment; ≥7 was accepted as severe malalignment.
Measured: 6 months after from beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start29 Mar 2021
- Primary completion14 Jun 2021 (estimated)
- Study completion16 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperkyphosis, AdolescentStudies 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
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Medipol University, Başakşehir Çam & Sakura City Hospital
- Responsible party
- Sponsor
- Investigators
- Ahsen Büyükaslan, PhD(c), Principal investigator, Medipol UniversityKadir Abul, M.D., Study chair, Başakşehir Çam & Sakura City HospitalHürriyet Yılmaz, Prof.Dr., Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924556
- Sponsor's protocol ID
- HUEK-
- Status last verified
- Jun 2021
- First submitted
- 26 May 2021
- Last updated
- 14 Jun 2021
- 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 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Rıgıd Brace on Spinopelvic Parameters and GAP Score in Adolescents With Structural Hyperkyphosis
- ClinicalTrials.gov ID
- NCT04924556
- Acronym / sponsor ID
- HUEK-
- Keywords
- Scheuermann Disease, Adolescent Hyperkyphosis, Sagittal Balance, Spinopelvic Parameters
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Medipol University, Başakşehir Çam & Sakura City Hospital
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 14 Jun 2021 (estimated)
- Study completion
- 16 Aug 2021 (estimated)
- First posted
- 14 Jun 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.
This study aimed to investigate the effect of rıgıd brace treatment on spinopelvic parameters and GAP score in patients with adolescent hyperkyphosis. This was a retrospective analysis of prospectively collected data. Thirty-two patients who were diagnosed with structural hyperkyphosis and treated with CAD-CAM design rigid brace were included in the study in Formed Healthcare Scoliosis Treatment and Brace Center between December 2015-2020.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 10-18 years patients with Scheuermann's kyphosis or adolescent hyperkyphosis and treated with CAD-CAM design a rigid brace
Key inclusion criteria (4 listed)
- Subjects who diagnosed with Scheuermann's kyphosis or adolescent hyperkyphosis.
- Inıtial curve magnitude between 55-75°
- Patients who followed up at least 6 months
- Patients who wearing CAD-CAM (Computer-Aided Design\&Computer-Aided Manufacturing) design TLSO(Thoraco-lumbo-sacral orthosis) kyphosis brace in 16 hours/day or more
Key exclusion criteria (4 listed)
- History of spinal surgery or trauma
- Patients has kyphosis due to congenital, neuromuscular, traumatic, tumor, infection causes
- Ankylosing spondylitis and other spondyloarthropathies.
- The lack of appropriate full-length lateral radiography with acceptable quality at the baseline or final assessment.
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
Change from kyphosis angle at 6 months
Time frame: 6 months after from beginning of study
Change from Baseline kyphosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure between T4-T12 vertebra.
Change from lordosis angle at 6 months
Time frame: 6 months after from beginning of study
Change from Baseline lordosis angle(degree) in standing full-length lateral digital radiographs at 6 months. It will measure from the L1-S1 and L4-S1 levels of the vertebra.
Change from the global tilt at 6 months
Time frame: 6 months after from beginning of study
Change from Baseline global tilt(degree) in standing full-length lateral digital radiographs at 6 months. The global tilt is the sum of the C7 vertical tilt and the pelvic tilt.
Change from Global Alignment and Proportion (GAP) score at 6 months
Time frame: 6 months after from beginning
GAP score is a new pelvic incidence-based proportional method to analyze sagittal alignment and balance, developed by the European Spine Study Group (ESSG). The GAP score evaluates the disproportion, magnitude and distribution of lumbar lordosis, and the global spinopelvic alignment proportionally rather than an absolute numerical value when compared to the ideal calculated for any individual. GAP score has five domains including relative pelvic version, relative lumbar lordosis, lordosis distribution index, relative spinopelvic alignment, and age factor. Scores of each of the four domains vary between 0 to 3 and age factor domain varies between 0 to 1. The total GAP score is between 0 and 13 points and obtained by adding the scores of these five domains. If the total score was 0 to 2, alignment accepted as proportional; 3 to 6 as moderate malalignment; ≥7 was accepted as severe malalignment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- 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.
Ahsen Büyükaslan, PhD(c) principal investigator
Medipol University
Kadir Abul, M.D. study chair
Başakşehir Çam & Sakura City Hospital
Hürriyet Yılmaz, Prof.Dr. study director
Halic University
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 Hyperkyphosis, Adolescent and Scheuermann Disease, run by Halic University at 1 site in Turkey (Türkiye).
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 4 inclusion and 4 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 14 Jun 2021. 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 Turkey (Türkiye). 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?
Contact Ahsen Büyükaslan, PhD(c) (905336992960, ahsen.buyukaslan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from kyphosis angle at 6 months (time frame: 6 months after from beginning of study). The study lists 4 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 14 Jun 2021.