Malignant TumorNCT05616195
Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors
An observational study of Malignant Tumor, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- 3D printed bone prosthesis replacement surgery
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 28 Dec 2024to 30 Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing 3D-printed bone prosthesis replacement surgery
Who may be able to join
- Men and women of all ages are welcome.
- Pathologically confirmed in our hospital as a subtype of malignant tumor.
- He received 3D printed bone prosthesis replacement in our hospital.
Who cannot join
- Not applicable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, Henan
Tian Zhichao, Dr., +8618737187831, tianzhichhaoyy@163.com
About this study
Official title: Application of 3D Printed Bone Prosthesis in Limb Salvage Surgery for Bone Tumors: a Single-center, Real-world Prospective Observational Study
To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients.
Read the detailed description
To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. The basic data, treatment methods, postoperative complications and limb function of these patients were collected.
- Conditions
- Malignant Tumor
- Being tested
- 3D printed bone prosthesis replacement surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D printed bone prosthesis replacement surgeryOther
To report the postoperative complications and limb function of patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital.
| Study group | Role | What they receive |
|---|---|---|
| 3D printed bone prosthesis replacement surgery | Patients undergoing 3D-printed bone prosthesis replacement surgery Receives: Other: 3D printed bone prosthesis replacement surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications
Complications were collected from patients who underwent 3D-printed bone prosthesis replacement surgery.
Measured: From surgery to 24 months after surgery
Limb function
Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.
Measured: Patients were enrolled until 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start28 Dec 2024 (estimated)
- Primary completion30 Nov 2032 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wang Jiaqiang, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616195
- Sponsor's protocol ID
- ZZUSC-18
- Status last verified
- Aug 2023
- First submitted
- 31 Oct 2022
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of 3D Printed Bone Prosthesis in Limb Salvage Surgery for Bone Tumors: a Single-center, Real-world Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05616195
- Acronym / sponsor ID
- ZZUSC-18
- Conditions
- Malignant Tumor
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 28 Dec 2024 (estimated)
- Primary completion
- 30 Nov 2032 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 15 Nov 2022 (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.
To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years, and collect the postoperative complications and limb function of these patients.
Detailed description
To report the patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital in the next 10 years. The basic data, treatment methods, postoperative complications and limb function of these patients were collected.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D printed bone prosthesis replacement surgery | – | Other: 3D printed bone prosthesis replacement surgeryPatients undergoing 3D-printed bone prosthesis replacement surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing 3D-printed bone prosthesis replacement surgery
Key inclusion criteria (3 listed)
- Men and women of all ages are welcome.
- Pathologically confirmed in our hospital as a subtype of malignant tumor.
- He received 3D printed bone prosthesis replacement in our hospital.
Key exclusion criteria (1 listed)
- Not applicable.
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 bone prosthesis replacement surgeryTo report the postoperative complications and limb function of patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital. | Other | 3D printed bone prosthesis replacement surgery |
Primary outcome
complications
Time frame: From surgery to 24 months after surgery
Complications were collected from patients who underwent 3D-printed bone prosthesis replacement surgery.
Limb function
Time frame: Patients were enrolled until 24 months after surgery
Limb function was assessed using the Musculoskeletal Oncology Society (MSTS) scoring scale for seven items, namely movement, pain, stability, deformity, strength, functional activity, and emotional receptiveness. The highest possible score is 35, with 5 points allocated to each project.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Department of Bone and Soft Tissue ,Henan Cancer Hospital
Zhengzhou, China
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 Malignant Tumor, run by Henan Cancer Hospital 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 1 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: opening soon, as of the sponsor's last update on 18 Jan 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications (time frame: From surgery to 24 months after surgery). The study lists 2 primary outcomes in all. 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 18 Jan 2024.