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Sagittal Spine Balance in Patients With Chest Wall Deformity

P

Pomeranian Medical University Szczecin

Status

Active, not recruiting

Conditions

Chest Deformities
Scoliosis Idiopathic Adolescent

Study type

Observational

Funder types

Other

Identifiers

NCT07070609
KB.006.134.2025

Details and patient eligibility

About

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.

Full 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?

Enrollment

60 estimated patients

Sex

All

Ages

10 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

sagittal balance disturbed

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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