Optical Surface Imaging Versus Conventional Photography as a Tool to Document the Surface Geometry of Pectus Excavatum

NCT04185870 | Completed

• 1 other identifier: METCZ20190151
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Pectus excavatum is the most common congenital anterior chest wall deformity, known to occur in 1:400 of new-borns. Complaints may be of cosmetic nature or as a consequence of (cardio)pulmonary impairment. Part of the current work-up of pectus excavatum patients in Zuyderland Medical Centre (Heerlen, the Netherlands) is visual documentation of the deformity. Visual documentation is performed utilising a single-reflex camera and consists of 5 standard photographs (acquired from different angles) and two specialised recordings. These specialised recordings encompass a recording to measure the pectus excavatum's depth and a raster stereography recording to create a three-dimensional perspective. However, this form of visual documentation is not efficient, as it is time- and labor-intensive for the photographer and patient. Recently, another study started that aims to investigate whether three-dimensional (3D) optical surface scans can be used to determine pectus severity, as compared to chest radiographs and computed tomography scans (3DPECTUS study; METCZ20190048; NCT03926078). Building on this study it was determined whether 3D optical surface scans can be used as a tool to document the surface geometry of pectus excavatum. To determine whether the current standard photographs and specialised recordings can be replaced by a 3D scan, both methods are compared. To make this comparison, the pectus excavatum depth was chosen as an objective measure of agreement. If there is good agreement, it is assumed that the standard photos can be replaced by a 3D photo in the current work-up. This will subsequently result in a time saving as well as a reduced burden for the patient while acquisition of 3D scans takes only 10 seconds.

Conditions

Pectus Excavatum; Funnel Chest

Outcome Measures

Primary Outcomes (3)

• Standard photography based pectus excavatum depth

  The pectus excavatum depth is derived from one of the specialized recordings. The depth is obtained by placing a rigid bar with rule over the most excavated part in the transversal plane.

  2 months

• 3D scan based pectus excavatum depth

  The pectus excavatum depth is calculated by slicing the 3D scan in the longitudinal direction. The pectus depth is subsequently calculated from the transversal slice with the most severe excavation.

  2 months

• Absolute agreement between the 3D scan and photography based pectus excavatum depth.

  The absolute agreement was assessed by calculation of the intraclass correlation coefficient.

  2 months

Study Arms (1)

3D scan and standard photography arm

EXPERIMENTAL

All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum. In addition, all participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

Diagnostic Test: 3D scan; Diagnostic Test: Standard photography

Interventions

3D scan DIAGNOSTIC_TEST

All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.

3D scan and standard photography arm

Standard photography DIAGNOSTIC_TEST

All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.

3D scan and standard photography arm

Eligibility Criteria

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

You may qualify if:

• All participants of the 3D PECTUS study (METCZ20190048; NCT03926078) that received a 3D scan and standard photographies.

You may not qualify if:

• Participants in which the photography based pectus excavatum depth was measured in the transversal plane.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

Study Sites (1)

Zuyderland Medical Centre

Heerlen, Limburg, 6419PC, Netherlands

Location

Related Publications (1)

• Daemen JHT, Loonen TGJ, Coorens NA, Maessen JG, Maal TJJ, Hulsewe KWE, Vissers YLJ, de Loos ER. Photographic documentation and severity quantification of pectus excavatum through three-dimensional optical surface imaging. J Vis Commun Med. 2020 Oct;43(4):190-197. doi: 10.1080/17453054.2020.1784711. Epub 2020 Aug 14.

  PMID: 32791868 DERIVED

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

Study Design

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

Model Details: All participants will receive standard photographs and a 3D scan

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: December 20, 2019
• Primary Completion: January 2, 2020
• Study Completion: January 2, 2020
• Last Updated: January 13, 2020

Record last verified: 2019-12

Locations

NL (1)