Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07070609

Sagittal Spine Balance in Patients With Chest Wall 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?

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatric Ortopedics Pomeranian Medical University,

Szczecin, 71-252, Poland

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. initial sagittal balance

    Time frame: 6 months

    Deviations in sagittal balance in patients before the procedure

Secondary outcomes

  1. initial distance

    Time frame: 1 day

    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.

Other outcomes

  1. final sagittal balance

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Pomeranian Medical University Szczecin

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.