An interventional study of 3D optical surface scan in Pectus Excavatum, sponsored by Zuyderland Medisch Centrum. Status unknown at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2020-11-04.
Sponsored by Zuyderland Medisch Centrum · Not applicable, Interventional, and Diagnostic
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.
79 studies on the registry are indexed under Funnel Chest; 10 are open to participants now.
This study's planned enrollment of 25 is below the median of 40 across 46 interventional studies indexed under Funnel Chest.
Browse Funnel Chest studies →Zuyderland Medisch Centrum is the lead sponsor of 64 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
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.
Mean change in distance
The mean distance of thoracic wall changes
Time frame: 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
The maximum distance of thoracic wall changes
Time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Volumetric changes
The volumetric chest wall changes
Time frame: Changes from baseline (prior to surgery) to the situation 2 weeks after surgery, as well as after 6 and 12 months
Predictors of chest wall changes
Predictors of chest wall changes, assessed by multivariate analysis.
Time frame: Changes in volume, mean and maximum distance from baseline to 12 months
This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Zuyderland Medisch Centrum