RecruitingNot ApplicableNCT05057143

3D Printed Implants for the Defect Reconstruction in Patients With Chest Wall Tumors

The Use of Individual 3D-implants in the Reconstruction of the Chest Wall in Patients With the Tumor Lesions of the Chest Wall for the Treatment, Restoration, and Improved Quality of Life Compared to Reconstruction With Titanium Plates


Sponsor

Blokhin's Russian Cancer Research Center

Enrollment

30 participants

Start Date

Jan 10, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

A patient with a tumor lesion of the chest wall undergoes CT scan with a step width of less than 1 mm, then engineers design an individual model to replace the defect. Using a 3D printer, a model is made based on titanium alloy powder. Preoperative preparation takes an average of 14-21 days. The next stage is surgical treatment in the amount of resection of the chest wall with plastic defect with an individual titanium implant. In some cases, the titanium framework is separated from the pleural cavity by a polytetrafluoroethylene plate in order to seal and prevent the development of pulmonary hernias. The advantages of titanium individual prostheses include accurate matching of the implant to the size and characteristics of the defect, individual modeling allows you to repeat the anatomical features of the patient. This method helps to recreate the original shape of the chest, and most importantly, symmetrical, relatively healthy half. With the help of titanium, individualized prostheses are made based on 3D modeling, which will reduce the incidence of complications, accelerate rehabilitation and improve the quality of life of patients with tumor lesions of the chest wall. The postoperative period takes 15-30 days.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Malignant neoplasm of ribs, sternum and clavicle
  • Malignant neoplasm of the connective and soft tissues of the chest
  • Neoplasm of uncertain or unknown nature of ribs, sternum and collarbone
  • Benign neoplasm of ribs, sternum and collarbone
  • Tumor lesions of the chest wall of any localization, malignant and benign, as well as of an uncertain or unknown nature
  • For malignant tumors: Grade 1-3
  • Lack of distant metastases
  • Signed informed consent

Exclusion Criteria11

  • Children, women during pregnancy, childbirth, women during breastfeeding.
  • Military personnel, with the exception of contract military personnel.
  • Persons with mental disorders.
  • Persons detained, taken into custody, serving a sentence in the form of restriction of freedom, arrest, imprisonment or administrative arrest.
  • Patients with distant metastases (except for a solitary focus in the chest wall without other manifestations of the disease)
  • Inoperable tumor
  • The presence of another malignant tumor at the time of examination
  • ECOG 4
  • Having an active or chronic fungal / bacterial / viral infection
  • Uncontrolled chronic diseases of the liver, kidneys in the acute stage
  • Presence of metastases

Interventions

DEVICEPlates

Titanium plates

DEVICEImplants

3D printed implants


Locations(1)

Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation

Moscow, Russia

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NCT05057143


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