Cho Ray hospital
Ho Chi Minh City, 700000, Vietnam
Location status: Recruiting
Location contact
Hung Do Phuoc, MD, PhD
CONTACT
Phu Nguyen Hoang, MD, MSc
CONTACT
NCT Number: NCT04449211
To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long bone defect in adults
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Early Phase 1
Ho Chi Minh City, 700000, Vietnam
Location status: Recruiting
Hung Do Phuoc, MD, PhD
CONTACT
Phu Nguyen Hoang, MD, MSc
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
Other names: Bone defect implant
Time frame: 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).
Time frame: 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.
Time frame: Post-operative day 1 to 12 months
the bone healing process is evaluated by the change in dual energy CT-scan result
Time frame: through study completion, an average of 1 year.
Rate of complications
Contact information is provided by the study sponsor or research team.
Hung Do Phuoc, MD, PhD
CONTACT
Phu Nguyen Hoang, MD, MSc
CONTACT
Cho Ray Hospital
Other
The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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