Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans (CHEST)

November 2, 2020 updated by: Zuyderland Medisch Centrum
Pectus excavatum is the most common anterior chest wall deformity that affects up to 1:400 of newborns. If an operative correction is indicated, patients are often operated via the Ravitsch or Nuss bar procedure. The latter (i.e. the Nuss bar procedure) is the most commonly performed procedure. During this procedure one or more metal bars are inserted behind the sternum to push the sternum back into its normal position. These bars remain in situ for two-to-three years before being removed. Despite the fact that the Nuss bar procedure is regarded as an effective procedure, retraction may occur after removal. A recent study has investigated this phenomenon, utilizing three-dimensional (3D) optical surface scans acquired before and after Nuss bar removal. The authors found statistically significant changes to occur in chest wall dimensions directly after, as well as between 2 and 8 weeks after Nuss bar explantation, in comparison to the situation just prior to bar removal. They, moreover, found the time the bar was in situ to be predictive for retraction. However, the authors also stressed that further studies are needed to reinforce their preliminary findings and perform long-term assessments. Subsequently, a similar study with long-term assessments will be conducted.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Heerlen, Limburg, Netherlands, 6419PC
        • Zuyderland Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients that received 1 or more Nuss bar(s) to treat pectus excavatum and is/are scheduled to be removed due to the end of treatment.

Exclusion Criteria:

  • Patients in which the Nuss bar(s) or its stabilizers are or have been dislocated.
  • Patients that received a second operation to treat any complications regarding the initial Nuss bar implantation.
  • Patients with proven connective tissue diseases (e.g. Marfan's syndrome).
  • Patients with a diagnosis of epilepsy (as the 3D scanner utilizes flashing light to acquire the torso topography)
  • Patients that are not fit to remain in a standing position with their arms above shoulder level for a maximum of 60 seconds.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 3D scan arm
This is a single arm study. Patients in this arm will receive a 3D scan just prior to, 2 weeks after, as well as 6 and 12 months after Nuss bar removal.
Other: 3D optical surface scan
A 3D optical surface scan is acquired utilizing a handheld 3D scanner. Such a scanner is comparable to an ordinary photo camera, however, it also records depth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in distance
Time Frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The mean distance of thoracic wall changes
Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Maximum change in distance
Time Frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The maximum distance of thoracic wall changes
Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Volumetric changes
Time Frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
The volumetric chest wall changes
Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictors of chest wall changes
Time Frame: Changes in volume, mean and maximum distance from baseline to 12 months
Predictors of chest wall changes, assessed by multivariate analysis.
Changes in volume, mean and maximum distance from baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zuyderland Medisch Centrum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

November 4, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METCZ20190103

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe