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临床试验/NCT04449211
NCT04449211招募中早期 1 期

The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant

Cho Ray Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
入组人数
10
试验地点
2
主要终点
Functional outcome of the upper limb

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Participants with contraindication to surgery
  • Participants do not agree to undergo surgery
  • Participants with local infection or soft tissue defect

结局指标

主要结局

Functional outcome of the upper limb

时间窗: 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

时间窗: 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

时间窗: Post-operative day 1 to 12 months

the bone healing process is evaluated by the change in dual energy CT-scan result

次要结局

  • Complications(through study completion, an average of 1 year.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hung Do Phuoc, MD, PhD

Associate Professor

Cho Ray Hospital

研究点 (2)

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