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

NCT04052321 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2020-11-04

No results posted yet for this study

Summary

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.

Conditions

  • Pectus Excavatum

Interventions

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.

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-31
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04052321 on ClinicalTrials.gov