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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04052321
Recruitment Status : Not yet recruiting
First Posted : August 9, 2019
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pectus Excavatum Other: 3D optical surface scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantification of Chest Wall Changes After Nuss Bar Removal Utilizing Three-dimensional Optical Surface Scans
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arm Intervention/treatment
Experimental: 3D scan arm
This is a single arm study. Patients in this arm will receive a 3D scan just prior to, directly after, as well as 3 and 6 months after Nuss bar removal.
Other: 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.




Primary Outcome Measures :
  1. Mean change in distance [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]
    The mean distance of thoracic wall changes

  2. Maximum change in distance [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]
    The maximum distance of thoracic wall changes

  3. Volumetric changes [ Time Frame: Changes from baseline (prior to surgery) to the situation directly after surgery, as well as after 3 and 6 months ]
    The volumetric chest wall changes


Secondary Outcome Measures :
  1. Predictors of chest wall changes [ Time Frame: Changes in volume, mean and maximum distance from baseline to 6 months ]
    Predictors of chest wall changes, assessed by multivariate analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04052321


Contacts
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Contact: Jean Daemen +31884597777 j.daemen@zuyderland.nl

Locations
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Netherlands
Zuyderland Medical Centre
Heerlen, Limburg, Netherlands, 6419PC
Contact: Jean Daemen    +31884597777    j.daemen@zuyderland.nl   
Sponsors and Collaborators
Zuyderland Medisch Centrum
Publications:
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Responsible Party: Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier: NCT04052321    
Other Study ID Numbers: METCZ20190103
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zuyderland Medisch Centrum:
Three-dimensional optical surface imaging
Chest wall changes
Additional relevant MeSH terms:
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Funnel Chest
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Musculoskeletal Abnormalities
Congenital Abnormalities