NCT05616195

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
80mo left

Started Dec 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress17%
Dec 2024Dec 2032

First Submitted

Initial submission to the registry

October 31, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
2.1 years until next milestone

Study Start

First participant enrolled

December 28, 2024

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2032

Last Updated

January 18, 2024

Status Verified

August 1, 2023

Enrollment Period

7.9 years

First QC Date

October 31, 2022

Last Update Submit

January 16, 2024

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (2)

  • complications

    Complications were collected from patients who underwent 3D-printed bone prosthesis replacement surgery.

    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.

    Patients were enrolled until 24 months after surgery

Study Arms (1)

3D printed bone prosthesis replacement surgery

Patients undergoing 3D-printed bone prosthesis replacement surgery

Other: 3D printed bone prosthesis replacement surgery

Interventions

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.

3D printed bone prosthesis replacement surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing 3D-printed bone prosthesis replacement surgery

You may qualify if:

  • 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.

You may not qualify if:

  • Not applicable.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Bone and Soft Tissue ,Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate chief physician

Study Record Dates

First Submitted

October 31, 2022

First Posted

November 15, 2022

Study Start

December 28, 2024

Primary Completion (Estimated)

November 30, 2032

Study Completion (Estimated)

December 30, 2032

Last Updated

January 18, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)