NCT03087734

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

October 24, 2016

Last Update Submit

October 9, 2021

Conditions

Funnel Chest

Keywords

Prostheses and Implants

Outcome Measures

Primary Outcomes (1)

  • Grade of metallic bar dislodgment measured through Rx images

    The grade of metallic bar dislodgment will be measured through the comparison of the Rx taken in patient follow up in terms of: a) bar flipping; b) lateral sliding and c) hinge-point disruption

    One year

Study Arms (2)

Perpendicular stabilizer

ACTIVE COMPARATOR

Implantation of regular bar with perpendicular stabilizers

Device: Implantation of regular bar with perpendicular stabilizers

Oblique stabilizer

EXPERIMENTAL

Implantation of new model of bar with oblique stabilizers

Device: Implantation of new model of bar with oblique stabilizers

Interventions

Implantation of new model of bar with oblique stabilizersDEVICE

Implantation of new model of bar with oblique stabilizers

Oblique stabilizer
Implantation of regular bar with perpendicular stabilizersDEVICE

Implantation of regular bar with perpendicular stabilizers

Perpendicular stabilizer

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pectus excavatum patients

You may not qualify if:

  • Presence of complex congenital anomalies;
  • Retardation neurodevelopment;
  • Congenital heart disease;
  • Chronic Immunosuppression.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute (InCor) Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Tedde ML, De Carvalho RLC, De Campos JRM, Da Silva DAG, Okumura EM, Guilherme GF, Marchesi AC, Petrizzo P, Souto Maior BS, Pego-Fernandes PM. Randomized comparison of oblique and perpendicular stabilizers for minimally invasive repair of pectus excavatum. Interdiscip Cardiovasc Thorac Surg. 2024 Mar 5;38(3):ivae040. doi: 10.1093/icvts/ivae040.

    PMID: 38492558DERIVED

MeSH Terms

Conditions

Funnel Chest

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Paulo M Pego-Fernandes

    Heart Institute (InCor), Hospital das Clinicas, University of Sao Paulo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 24, 2016

First Posted

March 22, 2017

Study Start

October 3, 2017

Primary Completion

September 25, 2018

Study Completion

March 1, 2019

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)