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 Details — Status: Recruiting

Administrative data

• NCT number: NCT04449211
• Other study ID #: ChoRayH
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2023
• Source: Cho Ray Hospital
• Contact: Hung Do Phuoc, MD, PhD
• Phone: +84903775579
• Email: dphungcr[@]ump.edu.vn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 30, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult participants with health insurance regardless of sex having bone defect greater than 5cm due to trauma or tumour resection agree to participate the research

Exclusion Criteria:

• Participants with contraindication to surgery

• Participants do not agree to undergo surgery

• Participants with local infection or soft tissue defect

Related Conditions & MeSH terms

• Bone Loss
• Defect Limb

Intervention

Device:
• Implantation
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant

Locations

Country	Name	City	State
Vietnam	Cho Ray hospital	Ho Chi Minh

Sponsors (3)

Lead Sponsor	Collaborator
Cho Ray Hospital	3 Dimensional Tech Vision Limited Company, Commonwealth Scientific and Industrial Research Organisation, Australia

Country where clinical trial is conducted

Vietnam, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome of the upper limb	For the participant with bone defect of the upper limb, the Disabilities of the Arm, Shoulder, and Hand (DASH) score will be used to evaluate for the limb functional outcome. The scale is ranging from 0 (no disability) to 100 (most severe disability).	1 to 12 months
Primary	Functional outcome of the lower limb	For the participant with bone defect of the lower limb, the Karlstrom & Olerud score will be used to evaluate for the limb functional outcome. The scale is graded as: bad, fair, good, excellent functional outcome.	1 to 12 months
Primary	Radiological imaging	the bone healing process is evaluated by the change in dual energy CT-scan result	Post-operative day 1 to 12 months
Secondary	Complications	Rate of complications	through study completion, an average of 1 year.