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

Not Applicable

• Conditions: Pectus Excavatum
• Interventions: Other: 3D optical surface scan

• Registration Number: NCT04052321
• Lead Sponsor: Zuyderland Medisch Centrum

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-08
• Study First Posted: 2019-08-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-04
• Study Start: 2021-01
• Primary Completion: 2022-01
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
3D scan arm	3D optical surface scan	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.

Primary Outcome Measures

Name	Time	Method
Volumetric changes	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
Mean change in distance	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
Maximum change in distance	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

Secondary Outcome Measures

Name	Time	Method
Predictors of chest wall changes	Changes in volume, mean and maximum distance from baseline to 12 months	Predictors of chest wall changes, assessed by multivariate analysis.

Trial Locations

Locations (1)

Zuyderland Medical Centre; 🇳🇱 Heerlen, Limburg, Netherlands