Osteosarcoma in ChildrenNCT05794594
3D Printed Personalized Extendable Prosthesis
An observational study of Osteosarcoma in Children, run by Yuxi Su at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteosarcoma in Children
- What is being tested?
- 3D printed personalized extendable prosthesis
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2015to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children with osteosarcoma undergoing prosthesis replacement or limb amputation were admitted to our hospital
Who may be able to join
- 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
Who cannot join
- recurrent tumors
- poorly differentiated tumors
- poor soft-tissue conditions
- neurovascular invasion around tumors
- ineffective chemotherapy with metastasis
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014
About this study
Official title: 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？
Read the 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.
- Conditions
- Osteosarcoma in Children
- Being tested
- 3D printed personalized extendable prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed personalized extendable prosthesisDevice
3D printed personalized extendable prosthesis replacement for limb preservation in children
| Study group | Role | What they receive |
|---|---|---|
| 3D printed | 3D printed personalized extendable prosthesis replacement for limb preservation in children with osteosarcoma Receives: Device: 3D printed personalized extendable prosthesis | |
| amputation | patients had undergone amputation of the limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Osteosarcoma recurrence rate
Measured: 7years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Oct 2015
- Primary completion1 Jan 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteosarcoma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuxi Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuxi Su, Children's Hospital of Chongqing Medical University
- Investigators
- Yuxi Su, Principal investigator, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794594
- Sponsor's protocol ID
- CHChongqingMU-2
- Status last verified
- Mar 2023
- First submitted
- 18 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Personalized Extendable Prosthesis Replacement for Limb Preservation in Children With Osteosarcoma: a Preliminary Study
- ClinicalTrials.gov ID
- NCT05794594
- Acronym / sponsor ID
- CHChongqingMU-2
- Conditions
- Osteosarcoma in Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Yuxi SuUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D printed | – | Device: 3D printed personalized extendable prosthesis3D printed personalized extendable prosthesis replacement for limb preservation in children with osteosarcoma |
| amputation | – | –patients had undergone amputation of the limbs |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children with osteosarcoma undergoing prosthesis replacement or limb amputation were admitted to our hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- recurrent tumors
- poorly differentiated tumors
- poor soft-tissue conditions
- neurovascular invasion around tumors
- ineffective chemotherapy with metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D printed personalized extendable prosthesis3D printed personalized extendable prosthesis replacement for limb preservation in children | Device | 3D printed |
Primary outcome
Recurrence
Time frame: 7years
Osteosarcoma recurrence rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Osteosarcoma in Children
RecruitingPhase 3
Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse
Osteosarcoma, Pediatric Osteosarcoma
RecruitingPhase 1
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Osteosarcoma Recurrent, Osteosarcoma in Children
Active, not recruitingPhase 2
Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Recurrent Childhood Ependymoma
RecruitingPhase 2
The CATSINDO Trial - Clinical and Translational Study in Newly Diagnosed Osteosarcoma
Osteosarcoma in Children, Osteosarcoma in Adolescents and Young Adults
RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuxi Su principal investigator
Children's Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma in Children, run by Yuxi Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 7years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.