Clinical trial NCT04449211: The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant
Official title: The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Bone Loss
Defect Limb
Keywords: bone defect
3D-printed Titanium alloy implant
Electron Beam Melting
customised implant
patient-specific implant
Lead sponsor: Cho Ray Hospital
Sponsor class: OTHER
Collaborators: name: Commonwealth Scientific and Industrial Research Organisation, Australia
name: 3 Dimensional Tech Vision Limited Company
First posted: 2020-06-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome of the upper limb
timeFrame: 1 to 12 months
measure: Functional outcome of the lower limb
timeFrame: 1 to 12 months
measure: Radiological imaging
timeFrame: Post-operative day 1 to 12 months
Secondary outcomes:
measure: Complications
timeFrame: through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Cho Ray hospital
Study officials:
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