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

Sponsor
Cho Ray Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04449211
Collaborator
Commonwealth Scientific and Industrial Research Organisation, Australia (Other), 3 Dimensional Tech Vision Limited Company (Other)
10
Enrollment
1
Location
1
Arm
15.9
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Implantation
 Early Phase 1

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Participants with massive bone defect

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
Other Names:
  • Bone defect implant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Functional outcome of the upper limb [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 [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 [Post-operative day 1 to 12 months]

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

    Secondary Outcome Measures

    1. Complications [through study completion, an average of 1 year.]

      Rate of complications

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cho Ray hospital Ho Chi Minh Vietnam 700000

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Hung Do Phuoc, MD, PhD, Associate Professor, Cho Ray Hospital
    ClinicalTrials.gov Identifier:
    NCT04449211
    Other Study ID Numbers:
    • ChoRayH
    First Posted:
    Jun 26, 2020
    Last Update Posted:
    Jul 26, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hung Do Phuoc, MD, PhD, Associate Professor, Cho Ray Hospital
    bone defect
    3D-printed Titanium alloy implant
    Electron Beam Melting
    customised implant
    patient-specific implant

    Study Results

    No Results Posted as of Jul 26, 2022