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Trials / Active Not Recruiting

Active Not RecruitingNCT07070609

Sagittal Spine Balance in Patients With Chest Wall Deformity

Assessment of Sagittal Spine Balance in Patients Operated on for Anterior Chest Wall Funnel Deformity

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
Pomeranian Medical University Szczecin · Academic / Other
Sex
All
Age
10 Years – 18 Years
Healthy volunteers
Not accepted

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. The aim of the study was to assess that sagittal balance of the spine change 6 months after surgical treatment? We assess: 1. Deviations in sagittal balance in patients before the procedure by X-ray. 2. 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. 3. 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: 1. Computed tomography of the chest. 2. 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). 3. 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: 1. Haller index 2. Asymmetry index 3. Assessment of the Cobb angle in the case of disorders in the frontal plane - before and 6 months after the procedure 4. Assessment of the sagittal balance of the spine (details in a separate document) - before and 6 months after the procedure We assess: 1. Deviations in sagittal balance in patients before the procedure by X-ray. 2. 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. 3. 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: 1. Does the funnel deformity affects the sagittal balance of the spine? 2. Does restoring the correct balance reduce the distance between the retracted sternum and the spine (AI)? 3. Does the sagittal balance of the spine change 6 months after surgical treatment?

Conditions

Timeline

Start date
2025-03-01
Primary completion
2026-01-01
Completion
2026-01-31
First posted
2025-07-17
Last updated
2025-07-17

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT07070609. Inclusion in this directory is not an endorsement.