3D Printed Personalized Extendable Prosthesis

Osteosarcoma in Children Clinical Trial

Official title:

3D Printed Personalized Extendable Prosthesis Replacement for Limb Preservation in Children With Osteosarcoma: a Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05794594
• Other study ID #: CHChongqingMU-2
• Status: Completed
• Start date: October 1, 2015
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2023
• Source: Children's Hospital of Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this type of observational study is to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma. The main question it aims to answer is: Is 3D printed personalized extendable prosthesis replacement has a good outcome in limb salvage pediatric osteosarcoma？

Description:

Osteosarcoma is one of the most common primary malignant bone tumors in children and adolescents. In this study, the investigators try to investigate the preliminary effect of 3D printed personalized extendable prosthesis replacement on limb salvage in children with osteosarcoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• tumors of the extremities, with moderate soft-tissue invasion
• the neurovascular bundle is not invaded, and the tumor can be excised totally
• no metastatic lesions or metastases can be cured

Exclusion Criteria:

• recurrent tumors
• poorly differentiated tumors
• poor soft-tissue conditions
• neurovascular invasion around tumors
• ineffective chemotherapy with metastasis

Related Conditions & MeSH terms

• Osteosarcoma
• Osteosarcoma in Children

Intervention

Device:
• 3D printed personalized extendable prosthesis
3D printed personalized extendable prosthesis replacement for limb preservation in children

Locations

Country	Name	City	State
China	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Yuxi Su

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Osteosarcoma recurrence rate	7years