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

NCT04052321 | Unknown DMC

• 1 other identifier: METCZ20190103
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Pectus Excavatum

Keywords

Three-dimensional optical surface imaging; Chest wall changes

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Predictors of chest wall changes

  Changes in volume, mean and maximum distance from baseline to 12 months

Study Arms (1)

3D scan arm

EXPERIMENTAL

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

Interventions

3D optical surface scan OTHER

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.

3D scan arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 28094014 BACKGROUND

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Jean Daemen

CONTACT

+31884597777; j.daemen@zuyderland.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 9, 2019
• Study Start: January 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: November 4, 2020

Record last verified: 2020-07

Locations

NL (1)