3D Printed Personalized Extendable Prosthesis

Sponsor

Yuxi Su (Other)

Overall Status

Completed

CT.gov ID

NCT05794594

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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？

Condition or Disease	Intervention/Treatment	Phase
Osteosarcoma in Children	Device: 3D printed personalized extendable prosthesis

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2015

Actual Primary Completion Date :

Jan 1, 2023

Actual Study Completion Date :

Mar 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
3D printed 3D printed personalized extendable prosthesis replacement for limb preservation in children with osteosarcoma	Device: 3D printed personalized extendable prosthesis 3D printed personalized extendable prosthesis replacement for limb preservation in children
amputation patients had undergone amputation of the limbs

Arm

Intervention/Treatment

3D printed

3D printed personalized extendable prosthesis replacement for limb preservation in children with osteosarcoma

Device: 3D printed personalized extendable prosthesis

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

amputation

patients had undergone amputation of the limbs

Outcome Measures

Primary Outcome Measures

Recurrence [7years]
Osteosarcoma recurrence rate

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Chongqing Medical University	Chongqing	Chongqing	China	400014

Sponsors and Collaborators

Yuxi Su

Investigators

Principal Investigator: Yuxi Su, Children's Hospital of Chongqing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yuxi Su, Children's Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT05794594

Other Study ID Numbers:

CHChongqingMU-2

First Posted:

Apr 3, 2023

Last Update Posted:

Apr 3, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Osteosarcoma

Study Results

No Results Posted as of Apr 3, 2023