3D Printed Personalized Extendable Prosthesis

March 30, 2023 updated by: Yuxi Su

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

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？

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

children with osteosarcoma undergoing prosthesis replacement or limb amputation were admitted to our hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 7years
Osteosarcoma recurrence rate
7years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuxi Su

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

March 1, 2023

Study Registration Dates

First Submitted

March 18, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 3, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHChongqingMU-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteosarcoma in Children

Clinical Trials on 3D printed personalized extendable prosthesis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe