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NCT05616195 Clinical Trial

Application of 3D Printed Prosthesis in Limb Salvage Surgery for Bone Tumors

Malignant Tumor Clinical Trial

Official title:
Application of 3D Printed Bone Prosthesis in Limb Salvage Surgery for Bone Tumors: a Single-center, Real-world Prospective Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05616195
Other study ID # ZZUSC-18
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 28, 2024
Est. completion date December 30, 2032

Study information
Verified date August 2023
Source Henan Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date December 30, 2032
Est. primary completion date November 30, 2032
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 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. Exclusion Criteria: Not applicable.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 3D printed bone prosthesis replacement surgery
To report the postoperative complications and limb function of patients who underwent 3D-printed bone prosthesis replacement in Henan Cancer Hospital.

Locations
Country Name City State
China Department of Bone and Soft Tissue ,Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)
Lead Sponsor Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary complications Complications were collected from patients who underwent 3D-printed bone prosthesis replacement surgery. From surgery to 24 months after surgery
Primary 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
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