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

Pectus Excavatum Clinical Trial

— CHEST  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04052321
• Other study ID #: METCZ20190103
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: January 2022

Study information

• Verified date: July 2020
• Source: Zuyderland Medisch Centrum
• Contact: Jean Daemen
• Phone: +31884597777
• Email: j.daemen[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Funnel Chest
• Pectus Excavatum

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Zuyderland Medical Centre	Heerlen	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Gomes-Fonseca J, Vilaça JL, Henriques-Coelho T, Direito-Santos B, Pinho ACM, Fonseca JC, Correia-Pinto J. A new methodology for assessment of pectus excavatum correction after bar removal in Nuss procedure: Preliminary study. J Pediatr Surg. 2017 Jul;52(7):1089-1097. doi: 10.1016/j.jpedsurg.2016.12.029. Epub 2017 Jan 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in distance	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
Primary	Maximum change in distance	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
Primary	Volumetric changes	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	Predictors of chest wall changes	Predictors of chest wall changes, assessed by multivariate analysis.	Changes in volume, mean and maximum distance from baseline to 12 months