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The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant

Bone Loss Clinical Trial

Official title:
The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant

Clinical Trial Summary

To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults

Clinical Trial Description

The participant with long bone defect or bone tumor of the extremity is referred to the Radiology Department to have a full CT-scan of both limbs to facilitate the later reconstruction. With the contralateral limb CT-scan data, the implant is designed with appropriate geometry and structures through online meetings with the scientists of CSIRO, Australia. Through this discussion, the supporting guides for the precise osteotomy will also be designed and would be 3D-printed later by 3 Dimensional Tech Vision Limited Company (Vietnam) with Poly Lactic Acid material. The 3D-printed metal parts will be manufactured using Titanium - 6 Aluminum - 4 Vanadium ELI (Extra Low Interstitial) material with Electron Beam Melting technology in CSIRO (Australia). Subsequently, the 3D-printed part will undergo mechanical tests using the Instron 5500R system (Australia) to validate its required mechanical properties. If this metal part cannot fulfill the mechanical requirements, the problematic geometry will be revised and re-designed. Another prototype will be 3D-printed with the same protocol and be tested until it qualified for the mechanical requirement. When the 3D-printed model passes the mechanical test, another 3D-printed metal part with a similar design will be manufactured before transferring to 3-Dimensional Tech Vision Limited Company (Vietnam) for post-processing, surface finishing, sterilising, packaging, labeling. Eventually, the implant will be sent to Cho Ray hospital. The amount of intraoperative blood loss and operative time will be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04449211
Study type Interventional
Source Cho Ray Hospital
Contact Hung Do Phuoc, MD, PhD
Phone +84903775579
Email dphungcr@ump.edu.vn
Status Recruiting
Phase Early Phase 1
Start date June 1, 2023
Completion date December 30, 2023
View Details
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