Quantifying Changes in the Thoracic Wall After Nuss Bar Removal in Pectus Excavatum Patients Using 3D Imaging

NCT07498699 | Completed

• 1 other identifier: Z2019101
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Pectus excavatum (funnel chest) is the most common congenital anterior thoracic wall deformity. It can be associated not only with cosmetic concerns but also with psychosocial and limiting somatic complaints. Patients with this condition are often treated surgically using the Nuss bar procedure, in which a metal bar is placed behind the sternum to effectively "pop out" the funnel chest. This bar typically remains in place for 2-3 years. To analyze how the thoracic wall changes after removal of the Nuss bar, we aim to capture three-dimensional (3D) images at four different time points: just before removal, immediately after, and at 6 and 12 months post-removal. When significant changes over time are detected, we aim to identify factors that may predict retraction or recurrence. Based on these predictive factors, individualized decision-making regarding the timing of Nuss bar removal can be optimized to minimize the risk of retraction or recurrence.

Conditions

Pectus Excavatum

Outcome Measures

Primary Outcomes (1)

• External Haller index

  just before removal, immediately after, and at 6 and 12 months post-removal.

Study Arms (1)

Postoperative 3D scans

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with pectus excavatum who are visit our outpatient clinic and are scheduled for the removal of their Nuss bar.

You may qualify if:

• Patients of all ages and genders with a Nuss bar eligible for removal.

You may not qualify if:

• Patients in whom the bar or stabilizing components were dislocated
• Patients who underwent a second surgery for their pectus excavatum following the initial placement of the Nuss bar
• Patients in whom retrosternal metal bars have been placed for any indication other than the treatment of pectus excavatum
• Patients with connective tissue disorders such as Marfan syndrome
• Patients diagnosed with epilepsy
• Patients who are unable to maintain a stationary standing position for approximately 60 seconds

Sponsors & Collaborators

• Erik de Loos: lead

Study Sites (1)

Zuyderland Medical Center

Heerlen, Netherlands

Location

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Thoracic surgeon

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: September 16, 2020
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)