The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant
NCT ID: NCT04449211
Last Updated: 2024-09-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
EARLY_PHASE1
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-10-06
Study Completion Date
2024-12-30
Brief Summary
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To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults
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Detailed Description
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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.
Conditions
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Bone Loss
Defect Limb
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Prospective participants with health insurance admitted to the Orthopaedic and Traumatology Department of Cho Ray hospital who get the diagnosis of bone defect greater than 5cm due to trauma or tumour resection.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Participants with massive bone defect
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.
The customised 3D-Printed implant is manufactured and undergoes post-processing treatment before being ready for implantation surgery.
Group Type
EXPERIMENTAL
Implantation
Intervention Type
DEVICE
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
Interventions
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Implantation
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
Intervention Type
DEVICE
Other Intervention Names
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Bone defect implant
Eligibility Criteria
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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
* Participants do not agree to undergo surgery
* Participants with local infection or soft tissue defect
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Commonwealth Scientific and Industrial Research Organisation, Australia
OTHER_GOV
Sponsor Role
collaborator
3 Dimensional Tech Vision Limited Company
UNKNOWN
Sponsor Role
collaborator
Cho Ray Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Hung Do Phuoc, MD, PhD
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Cho Ray hospital
Ho Chi Minh City, , Vietnam
Site Status
RECRUITING
Countries
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Vietnam
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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ChoRayH
Identifier Type: -
Identifier Source: org_study_id
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