Bone Loss, Defect Limb
Conditions
Keywords
bone defect, 3D-printed Titanium alloy implant, Electron Beam Melting, customised implant, patient-specific implant
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.
Interventions
DEVICEImplantation
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
Sponsors
Commonwealth Scientific and Industrial Research Organisation, Australia
3 Dimensional Tech Vision Limited Company
Cho Ray Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome of the upper limb | 1 to 12 months | 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). |
| Functional outcome of the lower limb | 1 to 12 months | 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. |
| Radiological imaging | Post-operative day 1 to 12 months | the bone healing process is evaluated by the change in dual energy CT-scan result |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | through study completion, an average of 1 year. | Rate of complications |
Countries
Vietnam
Contacts
Primary ContactHung Do Phuoc, MD, PhD
Backup ContactPhu Nguyen Hoang, MD, MSc
Outcome results
None listed