An Early Phase 1 interventional study of Implantation in Bone Loss and Defect Limb, sponsored by Cho Ray Hospital. Status unknown at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-03.
Sponsored by Cho Ray Hospital · Early Phase 1, Interventional, and Treatment
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.
487 studies on the registry are indexed under Bone Diseases, Metabolic; 74 are open to participants now.
This study's planned enrollment of 10 is below the median of 61 across 372 interventional studies indexed under Bone Diseases, Metabolic.
Browse Bone Diseases, Metabolic studies →Cho Ray Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion 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. The customised 3D-Printed implant is manufactured and undergoes post-processing treatment before being ready for implantation surgery.
Device: Implantation
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
Also known as: Bone defect implant
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).
Time frame: 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.
Time frame: 1 to 12 months
Radiological imaging
the bone healing process is evaluated by the change in dual energy CT-scan result
Time frame: Post-operative day 1 to 12 months
Complications
Rate of complications
Time frame: through study completion, an average of 1 year.
Plan to share: No — 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
This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Cho Ray Hospital