NCT03087734

Evaluation of a New Model of Metallic Bar and Stabilizer for Use in MIRPE

Completed NA Last updated 12 October 2021

What this trial tests

NA trial testing Implantation of new model of bar with oblique stabilizers in Funnel Chest in 30 participants. Completed in 1 March 2019.

Timeline

3 October 2017

Primary endpoint
25 September 2018

1 March 2019

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	3 October 2017
Primary completion	25 September 2018
Estimated completion	1 March 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Implantation of new model of bar with oblique stabilizers
• Implantation of regular bar with perpendicular stabilizers

Conditions studied

• Funnel Chest — all drugs for Funnel Chest →

Sponsor

University of Sao Paulo

Who can join

10 and older, any sex, with Funnel Chest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Pectus excavatum (PE) is the most common deformity of the chest wall, occurring in approximately 1/1000 people. Currently, surgical treatment by minimally invasive technique is consolidating as preferred technique for the treatment of this condition. In this technique a metal bar is inserted in retrosternal position, pushing the sternum without the necessity of resecting the condral cartilages. Despite the advantages obtained with this technique, it is not without complications and the displacement of the bar is one of the most important. In order to minimize this problem we developed a new model of stabilizers, as well as all necessary instruments for performing minimally invasive surgery. The aim of this study is to compare two surgical groups, one making use of the new oblique stabilizer compared to the conventional perpendicular stabilizer to determine which one has less displacement. Furthermore, this study also aims to assess the full range of instruments developed by a national company, to carry out this type of surgery, which has cost compatible with our economic reality, and that can be accessible to our Public Health patients.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Randomized comparison of oblique and perpendicular stabilizers for minimally invasive repair of pectus excavatum.
   Tedde ML, De Carvalho RLC, De Campos JRM, Da Silva DAG, et al · · 2024 · cited 2× · PMID 38492558 · DOI 10.1093/icvts/ivae040