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NCT Number: NCT04449211

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation

Device

Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant

Other names: Bone defect implant

Primary outcomes

  1. Functional outcome of the upper limb

    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).

  2. Functional outcome of the lower limb

    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.

  3. Radiological imaging

    Time frame: Post-operative day 1 to 12 months

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

Secondary outcomes

  1. Complications

    Time frame: through study completion, an average of 1 year.

    Rate of complications

Study contacts

Contact information is provided by the study sponsor or research team.

Hung Do Phuoc, MD, PhD

CONTACT

[email protected]

+84903775579

Phu Nguyen Hoang, MD, MSc

CONTACT

[email protected]

+84938689292

Sponsors and collaborators

Lead sponsor

Cho Ray Hospital

Other

Collaborators

  • 3 Dimensional Tech Vision Limited Company
  • Commonwealth Scientific and Industrial Research Organisation, Australia

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 26, 2020
Registry last updated
Sep 3, 2024

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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