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

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Implant Site Reaction; Sarcoma of Bone; Chest Wall Tumor; Tumor of Bone; Chest Wall Sarcoma
• Intervention / Treatment: Device: Implants; Device: Plates

Detailed Description

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 the patient's anthropometric data.

Manufacturing takes place by 3D printing on a titanium alloy powder certified for the manufacture of medical implants. The technology used is a type of SLS (Selective Laser Sintering) -technology, layer-by-layer laser melting of metal-powder compositions. The printing process begins with dividing the digital 3D model of the product into layers with a thickness of 20 to 100 microns in order to create a 2D image of each layer of the product (section). The industry standard format is STL (Stereolithography) file. This file enters a special machine software, where the information is analyzed and compared with the technical capabilities of the machine. Based on the data obtained, a production cycle of construction is launched, consisting of many cycles of building individual layers of the product.

The cycle for constructing a layer (section) consists of typical operations:

• applying a layer of powder of a given thickness to the construction plate;
• scanning by a laser beam of the section of the product layer. The laser beam is a source of heat, under the influence of which the particles of the material are sintered along the profile of the section of the model;
• lowering the platform into the depth of the construction well by an amount corresponding to the thickness of the construction layer.

The process of building products takes place in the SLM (Selective Laser Melting) chamber of the machine, filled with an inert gas argon. After construction, the product is removed from the printer chamber and sent for heat treatment, annealing, to relieve internal stresses and improve mechanical properties. After annealing, the product is separated from the platform and undergoes finishing, which combines various types of machining. The final stages of the technological process are product cleaning and technical quality control.

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 all cases, the titanium framework is separated from the pleural cavity by a synthetic polyester (Dacron) plate in order to seal and prevent the development of pulmonary hernias. The advantages of titanium individual implants 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Salkov; Phone Number: +79629346738; Email: salkov1994@icloud.com

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 115478
    • Recruiting
    • Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation
    • Contact: Alexander Salkov; Phone Number: +79629346738; Email: salkov1994@icloud.com
    • Principal Investigator: Pavel Kononets, PhD
    • Sub-Investigator: Teimuraz Charatishvili, PhD
    • Sub-Investigator: Nikolay Petrochenko, PhD
    • Sub-Investigator: Alexander Salkov
    • Principal Investigator: Aslan Valiev, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Implants; 3D printed implants
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.	Device: Plates; Titanium plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease-free survival	Time after treatment during which no sign of cancer is found	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of hospitalization rate	Time after surgery till the end of hospitalization	30 days
Comparison of safety assessment	Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0	24 months
Comparison of performance status according Karnofsky scale	Improvement on the Karnofsky scale by 10-30 points	24 months
Comparison of pain relief according Visual Analogue Scale	Improvement on the Visual Analogue Scale by 3-5 points	24 months
Comparison of pain relief according Whatkins scale	Improvement on the Whatkins scale by 1-2 points	24 months

Collaborators and Investigators

• Sponsor: Blokhin's Russian Cancer Research Center
• Investigators: Principal Investigator: Aslan Valiev, PhD, N.N. Blokhin NMRCO; Principal Investigator: Pavel Kononets, PhD, N.N. Blokhin NMRCO

Publications and helpful links

Helpful Links

• official site
• russian surcoma group site

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 15, 2021
• First Posted (Actual): September 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Chest Wall Tumor
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms; Sarcoma; Bone Neoplasms
• Other Study ID Numbers: CWP-2021-7-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No