Research objectives
1. Customized resection and reconstruction of bone tumors with 3D printing technology
2. Set up a surgical design protocol that takes into account MRI (tumor diagnosis) and CT (bone modeling) comprehensively
3. Production of a surgical guide of a spoke-type for bone tumor resection

Background
Malignant bone tumors in children are typically osteosarcoma and Ewing sarcoma, and the prevalence is in the order of distal femur, proximal tibia, and proximal humerus, and it is a rare disease that is diagnosed by 45 and 15 children under the age of 15 each year.
For the treatment of pediatric bone tumors, chemotherapy and reoperation for bone defects and soft tissue defects after extensive resection are mainly performed. When the tumor is removed with extensive reconstruction, giant bone defects are inevitable, and reconstruction of defects includes autologous bone transplantation, sinus bone transplantation, use of giant tumor artificial joint replacement, allogeneic or a mixture of autologous and artificial joint replacement, and recently, a customized bone tumor implant method based on 3D printing technology has been in the spotlight. This study aims to evaluate the utility of accurate tumor resection and functional reconstruction by creating a patient-specific resection guide and tumor replacement using 3D printing.
4. A study on the design of linked-type metal prosthesis that can be linked to existing artificial joints

 Supportive Care

A prospective study to apply whether accurate resection and complex reconstruction are possible using 3D printing in patients who plan extensive osteotomy due to malignant bone tumors in children.

[Detailed how to guide the resection]
1. Based on the patient's imaging data (3D CT and MRI, etc.), the resection location is selected and a 3D model (STL) is generated.
2. Design a guide that displays the ablation position using the digitally generated STL.

[Detailed location/method of making prosthesis]
1. Metal prosthesis using a 3D printer is produced together for bone defects that cannot be reconstructed even using existing tumor substitutes.
2. The patient's defect area is modeled digitally using image data (3DCT and MRI, etc.), referring to the normal bone shape or using mirror inversion.
3. EBM 3D printers and medical titanium alloy materials that meet the standards equivalent to ISO10993-1

Arm Label

Target Number of Participant

Arm Type

Arm Description

A prospective study to apply whether accurate resection and complex reconstruction are possible using 3D printing in patients who plan extensive osteotomy due to malignant bone tumors in children.

[Detailed how to guide the resection]
1. Based on the patient's imaging data (3D CT and MRI, etc.), the resection location is selected and a 3D model (STL) is generated.
2. Design a guide that displays the ablation position using the digitally generated STL.

[Detailed location/method of making prosthesis]
1. Metal prosthesis using a 3D printer is produced together for bone defects that cannot be reconstructed even using existing tumor substitutes.
2. The patient's defect area is modeled digitally using image data (3DCT and MRI, etc.), referring to the normal bone shape or using mirror inversion.
3. EBM 3D printers and medical titanium alloy materials that meet the standards equivalent to ISO10993-1

Gender

Age

Description

1) Pediatric and adolescent patients between 7 and 18 years of age with extensive resection due to malignant bone tumor.

1) Insufficient suturing of soft tissue
2) If there are signs of infection at the time of surgery
3) If life expectancy is less than 3 months
4) Except for studies using metal printing when conventional artificial joint substitutes can be sufficiently treated.
6) If you have an immune disease including acquired immunodeficiency disease

After checking the error with the planned resection margin in the resection using 3D printing, comparing the size of the resection margin set from the surgical tumor with the size of the resection margin confirmed in the pathological biopsy after resection, the resection status after surgery was evaluated through CT. The extent of resection is compared with the resection margin planned through image reconstruction.

  within the study period

 Primary cancer-related: Primary cancer type, treatment type, period

  within the study period

Stage-related: presence of metastasis to other organs and treatment history

  within the study period

Functional results: Confirmed through resection margin evaluation, MRI, CT combined evaluation, type of resection guide, functional results and joint range of motion evaluation on outpatient observation after surgical treatment, and check for complications related to treatment.

  within the study period