Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans (CHEST)
Primary Purpose
Pectus Excavatum
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
3D optical surface scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Pectus Excavatum focused on measuring Three-dimensional optical surface imaging, Chest wall changes
Eligibility Criteria
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.
Sites / Locations
- Zuyderland Medical Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3D scan arm
Arm Description
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.
Outcomes
Primary Outcome Measures
Mean change in distance
The mean distance of thoracic wall changes
Maximum change in distance
The maximum distance of thoracic wall changes
Volumetric changes
The volumetric chest wall changes
Secondary Outcome Measures
Predictors of chest wall changes
Predictors of chest wall changes, assessed by multivariate analysis.
Full Information
NCT ID
NCT04052321
First Posted
August 2, 2019
Last Updated
November 2, 2020
Sponsor
Zuyderland Medisch Centrum
1. Study Identification
Unique Protocol Identification Number
NCT04052321
Brief Title
Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
Acronym
CHEST
Official Title
Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zuyderland Medisch Centrum
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pectus Excavatum
Keywords
Three-dimensional optical surface imaging, Chest wall changes
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D scan arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
3D optical surface scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean change in distance
Description
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
Title
Maximum change in distance
Description
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
Title
Volumetric changes
Description
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
Secondary Outcome Measure Information:
Title
Predictors of chest wall changes
Description
Predictors of chest wall changes, assessed by multivariate analysis.
Time Frame
Changes in volume, mean and maximum distance from baseline to 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean Daemen
Phone
+31884597777
Email
j.daemen@zuyderland.nl
Facility Information:
Facility Name
Zuyderland Medical Centre
City
Heerlen
State/Province
Limburg
ZIP/Postal Code
6419PC
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Daemen
Phone
+31884597777
Email
j.daemen@zuyderland.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
28094014
Citation
Gomes-Fonseca J, Vilaca 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.
Results Reference
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Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
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