3D Printed Personalized Extendable Prosthesis | NCT05794594

Studies
3D Printed Personalized Extendable Prosthesis

NCT05794594

Sponsor

Yuxi Su

Status

Completed

Last Update Posted

Apr 3, 2023Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Osteosarcoma in Children

Interventions

3D printed personalized extendable prosthesis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Jan 1, 2023Actual

Completion Date

Mar 1, 2023Actual

First Submitted Date

Mar 18, 2023

First Submission Date that Met QC Criteria

Mar 30, 2023

First Posted Date

Apr 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2023

Last Update Posted Date

Apr 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yuxi Su, Children's Hospital of Chongqing Medical University, Children's Hospital of Chongqing Medical UniversitySponsor-Investigator

Lead Sponsor

Yuxi SuOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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？

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
3D printed personalized extendable prosthesis	Device	3D printed personalized extendable prosthesis replacement for limb preservation in children	3D printed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence	Osteosarcoma recurrence rate	7years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yuxi Su	Children's Hospital of Chongqing Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	400014	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided