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

NCT ID: NCT04052321

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2022-01-31

Brief Summary

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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

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Conditions

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Pectus Excavatum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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3D scan arm

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.

Group Type EXPERIMENTAL

3D optical surface scan

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zuyderland Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zuyderland Medical Centre

Heerlen, Limburg, Netherlands

Site Status

Countries

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Netherlands

Central Contacts

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Jean Daemen

Role: CONTACT

[email protected]
+31884597777

Facility Contacts

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Jean Daemen

Role: primary

[email protected]
+31884597777

References

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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.

Reference Type BACKGROUND
PMID: 28094014 (View on PubMed)

Other Identifiers

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METCZ20190103

Identifier Type: -

Identifier Source: org_study_id