NCT05794594

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？

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

7.3 years

First QC Date

March 18, 2023

Last Update Submit

March 30, 2023

Conditions

Osteosarcoma in Children

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Osteosarcoma recurrence rate

    7years

Study Arms (2)

3D printed

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

Device: 3D printed personalized extendable prosthesis

amputation

patients had undergone amputation of the limbs

Interventions

3D printed personalized extendable prosthesisDEVICE

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

3D printed

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400014, China

Location

Study Officials

  • Yuxi Su

    Children's Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Children's Hospital of Chongqing Medical University

Study Record Dates

First Submitted

March 18, 2023

First Posted

April 3, 2023

Study Start

October 1, 2015

Primary Completion

January 1, 2023

Study Completion

March 1, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Locations

CN(1)