Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

Pectus Excavatum Clinical Trial

— CRANE  

Official title:

Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04418583
• Other study ID #: METCZ20200071
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: March 2021

Study information

• Verified date: May 2020
• Source: Zuyderland Medisch Centrum
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

Diagnostic Test:
• Three-dimensional imaging
Three-dimensional surface images, acquired by the Artec Leo

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in chest wall dimensions	difference between baseline (first image) and image after application of the Crane technique	1 hour