Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging (CRANE)

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.

Study Overview

• Status: Unknown
• Conditions: Funnel Chest; Pectus Excavatum
• Intervention / Treatment: Diagnostic test: Three-dimensional imaging

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Limburg
    • Heerlen, Limburg, Netherlands, 6419PC
      • Recruiting
      • Zuyderland Medical Centre
      • Contact: Jean Daemen; Phone Number: +314597777; Email: j.daemen@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Three-dimensional imaging; Participants receive a three-dimensional image of their chest, just prior to and after application of the Crane technique.	Diagnostic test: Three-dimensional imaging; Three-dimensional surface images, acquired by the Artec Leo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in chest wall dimensions	difference between baseline (first image) and image after application of the Crane technique	1 hour

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: June 2, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: METCZ20200071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No