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

Plain Language Summary

Simplified for easier understanding

This study uses custom 3D-printed implants to reconstruct the chest wall after tumors are removed from the ribs, sternum (breastbone), or surrounding tissue. The goal is to evaluate whether these personalized implants can safely restore chest wall structure after surgery. **You may be eligible if...** - You have a tumor in or around the chest wall (ribs, sternum, or collarbone) — benign or malignant - Your tumor has not spread to distant parts of the body - You are able to consent and willing to participate **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have distant metastases (except in very limited specific circumstances) - Your tumor cannot be surgically removed - You have another active cancer - You have a severe active infection (bacterial, viral, or fungal) - You have very poor overall health (ECOG score of 4) - You have uncontrolled kidney or liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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