Scoliosis Idiopathic AdolescentNCT07070609
Sagittal Spine Balance in Patients With Chest Wall Deformity
An observational study of Scoliosis Idiopathic Adolescent and Chest Deformities, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Does the funnel deformity affects the sagittal balance of the spine? This question is a result of a Principal Investigator's novel observation, that in some cases restoring the correct balance reduce the distance between the retracted sternum and the spine. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent, Chest Deformities
- How many people
- 60 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pediatric patients operated on for anterior chest wall deformity.
Who may be able to join
- idiopathic funnel chest
- Haller index above 3.2
Who cannot join
- Previous surgery within the chest and spine regions
- Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
- Haller index below 3.2
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Ortopedics Pomeranian Medical University,
Szczecin, 71-252
About this study
Official title: Assessment of Sagittal Spine Balance in Patients Operated on for Anterior Chest Wall Funnel Deformity
Does the funnel deformity affects the sagittal balance of the spine? This question is a result of a Principal Investigator's novel observation, that in some cases restoring the correct balance reduce the distance between the retracted sternum and the spine.
The aim of the study was to assess that sagittal balance of the spine change 6 months after surgical treatment?
Read more
We assess:
- Deviations in sagittal balance in patients before the procedure by X-ray.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body 6 months after the Nuss procedure by X-ray.
Read the detailed description
Assessment of sagittal spine balance in patients operated on for anterior chest wall funnel deformity.
Inclusion criteria:
age 10-18 idiopathic funnel chest Haller index above 3.2
Exclusion criteria:
Previous surgery within the chest and spine regions Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome) Haller index below 3.2
Study protocol:
- Computed tomography of the chest.
- Before the procedure, x-ray of the entire spine in a standing position, including the entire chest, pelvis and hip joints in the anterior and lateral projections (technical parameters will be provided separately).
- Six months after the procedure, x-ray of the entire spine in a standing position, including the entire chest, pelvis and hip joints in the anterior and lateral projections (technical parameters will be provided separately).
The following are measured:
- Haller index
- Asymmetry index
- Assessment of the Cobb angle in the case of disorders in the frontal plane - before and 6 months after the procedure
- Assessment of the sagittal balance of the spine (details in a separate document) - before and 6 months after the procedure
We assess:
- Deviations in sagittal balance in patients before the procedure by X-ray.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body 6 months after the Nuss procedure by X-ray.
Objective:
- Does the funnel deformity affects the sagittal balance of the spine?
- Does restoring the correct balance reduce the distance between the retracted sternum and the spine (AI)?
- Does the sagittal balance of the spine change 6 months after surgical treatment?
- Conditions
- Scoliosis Idiopathic Adolescent, Chest Deformities
- Keywords
- scoliosis, sagittal balance, anterior chest wall deformity
- 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 |
|---|---|---|
| sagittal balance disturbed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial sagittal balance
Deviations in sagittal balance in patients before the procedure
Measured: 6 months
Secondary outcomes (1)
initial distance
Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Mar 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070609
- Sponsor's protocol ID
- KB.006.134.2025
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After asking of principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Sagittal Spine Balance in Patients Operated on for Anterior Chest Wall Funnel Deformity
- ClinicalTrials.gov ID
- NCT07070609
- Acronym / sponsor ID
- KB.006.134.2025
- Conditions
- Scoliosis Idiopathic Adolescent, Chest Deformities
- Keywords
- scoliosis, sagittal balance, anterior chest wall deformity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 17 Jul 2025 (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.
Does the funnel deformity affects the sagittal balance of the spine? This question is a result of a Principal Investigator's novel observation, that in some cases restoring the correct balance reduce the distance between the retracted sternum and the spine.
The aim of the study was to assess that sagittal balance of the spine change 6 months after surgical treatment?
We assess:
- Deviations in sagittal balance in patients before the procedure by X-ray.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body 6 months after the Nuss procedure by X-ray.
Detailed description
Assessment of sagittal spine balance in patients operated on for anterior chest wall funnel deformity.
Inclusion criteria:
age 10-18 idiopathic funnel chest Haller index above 3.2
Exclusion criteria:
Previous surgery within the chest and spine regions Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome) Haller index below 3.2
Study protocol:
- Computed tomography of the chest.
- Before the procedure, x-ray of the entire spine in a standing position, including the entire chest, pelvis and hip joints in the anterior and lateral projections (technical parameters will be provided separately).
- Six months after the procedure, x-ray of the entire spine in a standing position, including the entire chest, pelvis and hip joints in the anterior and lateral projections (technical parameters will be provided separately).
The following are measured:
- Haller index
- Asymmetry index
- Assessment of the Cobb angle in the case of disorders in the frontal plane - before and 6 months after the procedure
- Assessment of the sagittal balance of the spine (details in a separate document) - before and 6 months after the procedure
We assess:
- Deviations in sagittal balance in patients before the procedure by X-ray.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body after virtual reproduction of the correct sagittal balance by AI.
- Change in the distance between the sternum and the anterior part of the nearest vertebral body 6 months after the Nuss procedure by X-ray.
Objective:
- Does the funnel deformity affects the sagittal balance of the spine?
- Does restoring the correct balance reduce the distance between the retracted sternum and the spine (AI)?
- Does the sagittal balance of the spine change 6 months after surgical treatment?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sagittal balance disturbed | – | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients operated on for anterior chest wall deformity.
Key inclusion criteria (2 listed)
- idiopathic funnel chest
- Haller index above 3.2
Key exclusion criteria (3 listed)
- Previous surgery within the chest and spine regions
- Anterior chest wall deformities caused by other disease syndromes (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
- Haller index below 3.2
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
initial sagittal balance
Time frame: 6 months
Deviations in sagittal balance in patients before the procedure
1 secondary outcome
initial distance
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Individual participant dataSharing planned: Undecided. After asking of principal investigator
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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?
An observational study of Scoliosis Idiopathic Adolescent and Chest Deformities, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
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?
initial sagittal balance (time frame: 6 months). 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 17 Jul 2025.