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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Federal State Budgetary Institution N.N. Blokhin National Medical Research Center of Oncology оf the Ministry of Health of the Russian Federation
RECRUITING
Moscow
Contact Information
Primary
Alexander Salkov
salkov1994@icloud.com
+79629346738
Time Frame
Start Date: 2022-01-10
Estimated Completion Date: 2025-12
Participants
Target number of participants: 30
Treatments
Experimental: Replacement of a defect in the chest wall with an individual implant
A patient with a tumor lesion of the chest wall undergoes СT 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 the patient's anthropometric data.
Active_comparator: Replacement of a defect in the chest wall with titanium plates
The use of standard titanium plates to replace the chest defect. These plates must be modeled and modified using special equipment intraoperatively, based on the characteristics of the defect after resection.
Related Therapeutic Areas
Sponsors
Leads: Blokhin's Russian Cancer Research Center

This content was sourced from clinicaltrials.gov