NCT07070609

Brief 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. 1.Deviations in sagittal balance in patients before the procedure by X-ray.
  2. 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 8, 2025

Last Update Submit

July 16, 2025

Conditions

Scoliosis Idiopathic AdolescentChest Deformities

Keywords

scoliosissagittal balanceanterior chest wall deformity

Outcome Measures

Primary Outcomes (1)

  • initial sagittal balance

    Deviations in sagittal balance in patients before the procedure

    6 months

Secondary Outcomes (1)

  • initial distance

    1 day

Other Outcomes (1)

  • final sagittal balance

    6 months

Study Arms (1)

sagittal balance disturbed

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric patients operated on for anterior chest wall deformity.

You may qualify if:

  • idiopathic funnel chest
  • Haller index above 3.2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric Ortopedics Pomeranian Medical University,

Szczecin, 71-252, Poland

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

March 1, 2025

Primary Completion

January 1, 2026

Study Completion

January 31, 2026

Last Updated

July 17, 2025

Record last verified: 2025-07

Locations

PL(1)