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

NCT05057143 | Recruiting

• 1 other identifier: CWP-2021-7-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tumor of Bone; Chest Wall Tumor; Chest Wall Sarcoma; Sarcoma of Bone; Surgery; Implant Site Reaction

Keywords

Chest Wall Tumor; Surgery

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  Time after treatment during which no sign of cancer is found

  24 months

Secondary Outcomes (5)

• Comparison of hospitalization rate

  30 days

• Comparison of safety assessment

  24 months

• Comparison of performance status according Karnofsky scale

  24 months

• Comparison of pain relief according Visual Analogue Scale

  24 months

• Comparison of pain relief according Whatkins scale

  24 months

Study Arms (2)

Replacement of a defect in the chest wall with an individual implant

EXPERIMENTAL

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

Replacement of a defect in the chest wall with titanium plates

ACTIVE COMPARATOR

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

Interventions

Implants DEVICE

3D printed implants

Replacement of a defect in the chest wall with an individual implant

Plates DEVICE

Titanium plates

Replacement of a defect in the chest wall with titanium plates

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blokhin's Russian Cancer Research Center: lead

Study Sites (1)

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

Moscow, 115478, Russia

RECRUITING

Related Links

• official site
• russian surcoma group site

MeSH Terms

Conditions

Bone Neoplasms; Osteosarcoma

Interventions

Bone Plates

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma

Intervention Hierarchy (Ancestors)

Internal Fixators; Prostheses and Implants; Equipment and Supplies; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Surgical Fixation Devices

Study Officials

• Aslan Valiev, PhD

  N.N. Blokhin NMRCO

  PRINCIPAL INVESTIGATOR

• Pavel Kononets, PhD

  N.N. Blokhin NMRCO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Salkov

CONTACT

+79629346738; salkov1994@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 27, 2021
• Study Start: January 10, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)