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| Name | Class |
|---|---|
| Commonwealth Scientific and Industrial Research Organisation, Australia | OTHER_GOV |
| 3 Dimensional Tech Vision Limited Company | UNKNOWN |
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To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with massive bone defect | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation | Device | Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Radiological imaging | the bone healing process is evaluated by the change in dual energy CT-scan result | Post-operative day 1 to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Rate of complications | through study completion, an average of 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hung Do Phuoc, MD, PhD | Contact | +84903775579 | dphungcr@ump.edu.vn | |
| Phu Nguyen Hoang, MD, MSc | Contact | +84938689292 | nguyenhoangphu@ump.edu.vn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cho Ray hospital | Recruiting | Ho Chi Minh City | 700000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21738065 | Background | Nauth A, McKee MD, Einhorn TA, Watson JT, Li R, Schemitsch EH. Managing bone defects. J Orthop Trauma. 2011 Aug;25(8):462-6. doi: 10.1097/BOT.0b013e318224caf0. | |
| 15736731 | Background | Keating JF, Simpson AH, Robinson CM. The management of fractures with bone loss. J Bone Joint Surg Br. 2005 Feb;87(2):142-50. doi: 10.1302/0301-620x.87b2.15874. No abstract available. |
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Limited data are available only to research providing high quality (of sufficient details as to be useful for research purposes) and accessible (able to be acquired and used) data for research. Those data also include the deidentified data such as X-Ray, CT-scan, MRI, etc. and do not include any identified information
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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.
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