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

NCT04418583 | Unknown

• 1 other identifier: METCZ20200071
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pectus Excavatum; Funnel Chest

Outcome Measures

Primary Outcomes (1)

• Mean change in chest wall dimensions

  difference between baseline (first image) and image after application of the Crane technique

  1 hour

Study Arms (1)

Three-dimensional imaging

EXPERIMENTAL

Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.

Diagnostic Test: Three-dimensional imaging

Interventions

Three-dimensional imaging DIAGNOSTIC_TEST

Three-dimensional surface images, acquired by the Artec Leo

Three-dimensional imaging

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

RECRUITING

MeSH Terms

Conditions

Funnel Chest

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective case-control study wherein participants are their own control

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 5, 2020
• Study Start: May 13, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-05

Locations

NL (1)