<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04449211</url>
  </required_header>
  <id_info>
    <org_study_id>ChoRayH</org_study_id>
    <nct_id>NCT04449211</nct_id>
  </id_info>
  <brief_title>The Effectiveness in the Treatment of Long Bone Defect Using 3D-printed Implant</brief_title>
  <official_title>The Effectiveness in the Treatment of Long Bone Defect in Adults Using 3D-printed Titanium Alloy Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cho Ray Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Commonwealth Scientific and Industrial Research Organisation, Australia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>3 Dimensional Tech Vision Limited Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cho Ray Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effectiveness of 3D-printed titanium alloy implants in the treatment of long&#xD;
      bone defect in adults&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participant with long bone defect or bone tumor of the extremity is referred to the&#xD;
      Radiology Department to have a full CT-scan of both limbs to facilitate the later&#xD;
      reconstruction. With the contralateral limb CT-scan data, the implant is designed with&#xD;
      appropriate geometry and structures through online meetings with the scientists of CSIRO,&#xD;
      Australia. Through this discussion, the supporting guides for the precise osteotomy will also&#xD;
      be designed and would be 3D-printed later by 3 Dimensional Tech Vision Limited Company&#xD;
      (Vietnam) with Poly Lactic Acid material. The 3D-printed metal parts will be manufactured&#xD;
      using Titanium - 6 Aluminum - 4 Vanadium ELI (Extra Low Interstitial) material with Electron&#xD;
      Beam Melting technology in CSIRO (Australia). Subsequently, the 3D-printed part will undergo&#xD;
      mechanical tests using the Instron 5500R system (Australia) to validate its required&#xD;
      mechanical properties. If this metal part cannot fulfill the mechanical requirements, the&#xD;
      problematic geometry will be revised and re-designed. Another prototype will be 3D-printed&#xD;
      with the same protocol and be tested until it qualified for the mechanical requirement. When&#xD;
      the 3D-printed model passes the mechanical test, another 3D-printed metal part with a similar&#xD;
      design will be manufactured before transferring to 3-Dimensional Tech Vision Limited Company&#xD;
      (Vietnam) for post-processing, surface finishing, sterilising, packaging, labeling.&#xD;
      Eventually, the implant will be sent to Cho Ray hospital. The amount of intraoperative blood&#xD;
      loss and operative time will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2023</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Functional outcome of the upper limb</measure>
    <time_frame>1 to 12 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Functional outcome of the lower limb</measure>
    <time_frame>1 to 12 months</time_frame>
    <description>For the participant with bone defect of the lower limb, the Karlstrom &amp; Olerud score will be used to evaluate for the limb functional outcome. The scale is graded as: bad, fair, good, excellent functional outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiological imaging</measure>
    <time_frame>Post-operative day 1 to 12 months</time_frame>
    <description>the bone healing process is evaluated by the change in dual energy CT-scan result</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>through study completion, an average of 1 year.</time_frame>
    <description>Rate of complications</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Bone Loss</condition>
  <condition>Defect Limb</condition>
  <arm_group>
    <arm_group_label>Participants with massive bone defect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.&#xD;
The customised 3D-Printed implant is manufactured and undergoes post-processing treatment before being ready for implantation surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Implantation</intervention_name>
    <description>Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant</description>
    <arm_group_label>Participants with massive bone defect</arm_group_label>
    <other_name>Bone defect implant</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult participants with health insurance regardless of sex having bone defect greater&#xD;
             than 5cm due to trauma or tumour resection agree to participate the research&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with contraindication to surgery&#xD;
&#xD;
          -  Participants do not agree to undergo surgery&#xD;
&#xD;
          -  Participants with local infection or soft tissue defect&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hung Do Phuoc, MD, PhD</last_name>
    <phone>+84903775579</phone>
    <email>dphungcr@ump.edu.vn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Phu Nguyen Hoang, MD, MSc</last_name>
    <phone>+84938689292</phone>
    <email>nguyenhoangphu@ump.edu.vn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cho Ray hospital</name>
      <address>
        <city>Ho Chi Minh</city>
        <zip>700000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hung Do Phuoc, MD, PhD</last_name>
      <phone>+84903775579</phone>
      <email>dphungcr@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Phu Nguyen Hoang, MD, MSc</last_name>
      <phone>+84938689292</phone>
      <email>nguyenhoangphu@ump.edu.vn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <reference>
    <citation>Nauth A, McKee MD, Einhorn TA, Watson JT, Li R, Schemitsch EH. Managing bone defects. J Orthop Trauma. 2011 Aug;25(8):462-6. doi: 10.1097/BOT.0b013e318224caf0.</citation>
    <PMID>21738065</PMID>
  </reference>
  <reference>
    <citation>Keating JF, Simpson AH, Robinson CM. The management of fractures with bone loss. J Bone Joint Surg Br. 2005 Feb;87(2):142-50. doi: 10.1302/0301-620x.87b2.15874. No abstract available.</citation>
    <PMID>15736731</PMID>
  </reference>
  <reference>
    <citation>Kironde E, Sekimpi P, Kajja I, Mubiri P. Prevalence and patterns of traumatic bone loss following open long bone fractures at Mulago Hospital. OTA Int. 2019 Mar 12;2(1):e015. doi: 10.1097/OI9.0000000000000015. eCollection 2019 Mar.</citation>
    <PMID>33937651</PMID>
  </reference>
  <reference>
    <citation>Le LC, Blum RW. Road traffic injury among young people in Vietnam: evidence from two rounds of national adolescent health surveys, 2004-2009. Glob Health Action. 2013 Jan 17;6:1-9. doi: 10.3402/gha.v6i0.18757.</citation>
    <PMID>23336620</PMID>
  </reference>
  <reference>
    <citation>Ivers RQ, Nguyen HT, La QN. Status of road safety and injury burden: Vietnam. J Orthop Trauma. 2014;28 Suppl 1:S50-1. doi: 10.1097/BOT.0000000000000098. No abstract available.</citation>
    <PMID>24858002</PMID>
  </reference>
  <reference>
    <citation>Masquelet AC, Begue T. The concept of induced membrane for reconstruction of long bone defects. Orthop Clin North Am. 2010 Jan;41(1):27-37; table of contents. doi: 10.1016/j.ocl.2009.07.011.</citation>
    <PMID>19931050</PMID>
  </reference>
  <reference>
    <citation>Iacobellis C, Berizzi A, Aldegheri R. Bone transport using the Ilizarov method: a review of complications in 100 consecutive cases. Strategies Trauma Limb Reconstr. 2010 Apr;5(1):17-22. doi: 10.1007/s11751-010-0085-9. Epub 2010 Mar 9.</citation>
    <PMID>20360874</PMID>
  </reference>
  <reference>
    <citation>Belthur MV, Conway JD, Jindal G, Ranade A, Herzenberg JE. Bone graft harvest using a new intramedullary system. Clin Orthop Relat Res. 2008 Dec;466(12):2973-80. doi: 10.1007/s11999-008-0538-3. Epub 2008 Oct 8.</citation>
    <PMID>18841433</PMID>
  </reference>
  <reference>
    <citation>Cricchio G, Lundgren S. Donor site morbidity in two different approaches to anterior iliac crest bone harvesting. Clin Implant Dent Relat Res. 2003;5(3):161-9. doi: 10.1111/j.1708-8208.2003.tb00198.x.</citation>
    <PMID>14575632</PMID>
  </reference>
  <reference>
    <citation>Robertson PA, Wray AC. Natural history of posterior iliac crest bone graft donation for spinal surgery: a prospective analysis of morbidity. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1473-6. doi: 10.1097/00007632-200107010-00018.</citation>
    <PMID>11458153</PMID>
  </reference>
  <reference>
    <citation>Campana V, Milano G, Pagano E, Barba M, Cicione C, Salonna G, Lattanzi W, Logroscino G. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014 Oct;25(10):2445-61. doi: 10.1007/s10856-014-5240-2. Epub 2014 May 28.</citation>
    <PMID>24865980</PMID>
  </reference>
  <reference>
    <citation>Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.</citation>
    <PMID>23247591</PMID>
  </reference>
  <reference>
    <citation>de Alencar PG, Vieira IF. BONE BANKS. Rev Bras Ortop. 2015 Nov 16;45(6):524-8. doi: 10.1016/S2255-4971(15)30297-4. eCollection 2010 Nov-Dec.</citation>
    <PMID>27026958</PMID>
  </reference>
  <reference>
    <citation>Mauffrey C, Barlow BT, Smith W. Management of segmental bone defects. J Am Acad Orthop Surg. 2015 Mar;23(3):143-53. doi: 10.5435/JAAOS-D-14-00018.</citation>
    <PMID>25716002</PMID>
  </reference>
  <reference>
    <citation>Matsuno H, Yokoyama A, Watari F, Uo M, Kawasaki T. Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. Biomaterials. 2001 Jun;22(11):1253-62. doi: 10.1016/s0142-9612(00)00275-1.</citation>
    <PMID>11336297</PMID>
  </reference>
  <reference>
    <citation>Rotta, G., T. Seramak, and K. Zasińska, Estimation of Young's Modulus of the Porous Titanium Alloy with the Use of Fem Package. Advances in Materials Science, 2015. 15(4): p. 29 - 37</citation>
  </reference>
  <reference>
    <citation>Elias, C.N., et al., Biomedical applications of titanium and its alloys. JOM, 2008. 60(3): p. 46-49</citation>
  </reference>
  <reference>
    <citation>Heinl P, Muller L, Korner C, Singer RF, Muller FA. Cellular Ti-6Al-4V structures with interconnected macro porosity for bone implants fabricated by selective electron beam melting. Acta Biomater. 2008 Sep;4(5):1536-44. doi: 10.1016/j.actbio.2008.03.013. Epub 2008 Apr 10.</citation>
    <PMID>18467197</PMID>
  </reference>
  <reference>
    <citation>Rho JY, Ashman RB, Turner CH. Young's modulus of trabecular and cortical bone material: ultrasonic and microtensile measurements. J Biomech. 1993 Feb;26(2):111-9. doi: 10.1016/0021-9290(93)90042-d.</citation>
    <PMID>8429054</PMID>
  </reference>
  <reference>
    <citation>Niinomi, M., Mechanical properties of biomedical titanium alloys. Materials Science and Engineering: A, 1998. 243(1): p. 231-236</citation>
  </reference>
  <reference>
    <citation>Head WC, Bauk DJ, Emerson RH Jr. Titanium as the material of choice for cementless femoral components in total hip arthroplasty. Clin Orthop Relat Res. 1995 Feb;(311):85-90.</citation>
    <PMID>7634595</PMID>
  </reference>
  <reference>
    <citation>Shi L, Shi L, Wang L, Duan Y, Lei W, Wang Z, Li J, Fan X, Li X, Li S, Guo Z. The improved biological performance of a novel low elastic modulus implant. PLoS One. 2013;8(2):e55015. doi: 10.1371/journal.pone.0055015. Epub 2013 Feb 21.</citation>
    <PMID>23437048</PMID>
  </reference>
  <reference>
    <citation>Stoppie N, Van Oosterwyck H, Jansen J, Wolke J, Wevers M, Naert I. The influence of Young's modulus of loaded implants on bone remodeling: an experimental and numerical study in the goat knee. J Biomed Mater Res A. 2009 Sep 1;90(3):792-803. doi: 10.1002/jbm.a.32145.</citation>
    <PMID>18615463</PMID>
  </reference>
  <reference>
    <citation>Sumner DR, Turner TM, Igloria R, Urban RM, Galante JO. Functional adaptation and ingrowth of bone vary as a function of hip implant stiffness. J Biomech. 1998 Oct;31(10):909-17. doi: 10.1016/s0021-9290(98)00096-7.</citation>
    <PMID>9840756</PMID>
  </reference>
  <reference>
    <citation>Ryan G, Pandit A, Apatsidis DP. Fabrication methods of porous metals for use in orthopaedic applications. Biomaterials. 2006 May;27(13):2651-70. doi: 10.1016/j.biomaterials.2005.12.002. Epub 2006 Jan 19.</citation>
    <PMID>16423390</PMID>
  </reference>
  <reference>
    <citation>Taniguchi N, Fujibayashi S, Takemoto M, Sasaki K, Otsuki B, Nakamura T, Matsushita T, Kokubo T, Matsuda S. Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment. Mater Sci Eng C Mater Biol Appl. 2016 Feb;59:690-701. doi: 10.1016/j.msec.2015.10.069. Epub 2015 Oct 28.</citation>
    <PMID>26652423</PMID>
  </reference>
  <reference>
    <citation>Sallica-Leva E, Jardini AL, Fogagnolo JB. Microstructure and mechanical behavior of porous Ti-6Al-4V parts obtained by selective laser melting. J Mech Behav Biomed Mater. 2013 Oct;26:98-108. doi: 10.1016/j.jmbbm.2013.05.011. Epub 2013 May 29.</citation>
    <PMID>23773976</PMID>
  </reference>
  <reference>
    <citation>Dallago M, Fontanari V, Torresani E, Leoni M, Pederzolli C, Potrich C, Benedetti M. Fatigue and biological properties of Ti-6Al-4V ELI cellular structures with variously arranged cubic cells made by selective laser melting. J Mech Behav Biomed Mater. 2018 Feb;78:381-394. doi: 10.1016/j.jmbbm.2017.11.044. Epub 2017 Dec 6.</citation>
    <PMID>29220822</PMID>
  </reference>
  <reference>
    <citation>Vasconcellos LM, Leite DO, Oliveira FN, Carvalho YR, Cairo CA. Evaluation of bone ingrowth into porous titanium implant: histomorphometric analysis in rabbits. Braz Oral Res. 2010 Oct-Dec;24(4):399-405. doi: 10.1590/s1806-83242010000400005.</citation>
    <PMID>21180959</PMID>
  </reference>
  <reference>
    <citation>Chang B, Song W, Han T, Yan J, Li F, Zhao L, Kou H, Zhang Y. Influence of pore size of porous titanium fabricated by vacuum diffusion bonding of titanium meshes on cell penetration and bone ingrowth. Acta Biomater. 2016 Mar;33:311-21. doi: 10.1016/j.actbio.2016.01.022. Epub 2016 Jan 21.</citation>
    <PMID>26802441</PMID>
  </reference>
  <reference>
    <citation>Rybicki, F.J., 3D Printing in Medicine: A Practical Guide for Medical Professionals. 2017: Springer. 1 - 22</citation>
  </reference>
  <reference>
    <citation>Zadpoor, A.A., Mechanical meta-materials. Materials Horizons, 2016. 3(5): p. 371-381</citation>
  </reference>
  <reference>
    <citation>Imanishi J, Choong PF. Three-dimensional printed calcaneal prosthesis following total calcanectomy. Int J Surg Case Rep. 2015;10:83-7. doi: 10.1016/j.ijscr.2015.02.037. Epub 2015 Mar 10.</citation>
    <PMID>25827294</PMID>
  </reference>
  <reference>
    <citation>Aranda JL, Jimenez MF, Rodriguez M, Varela G. Tridimensional titanium-printed custom-made prosthesis for sternocostal reconstruction. Eur J Cardiothorac Surg. 2015 Oct;48(4):e92-4. doi: 10.1093/ejcts/ezv265. Epub 2015 Aug 4.</citation>
    <PMID>26242897</PMID>
  </reference>
  <reference>
    <citation>Kim D, Lim JY, Shim KW, Han JW, Yi S, Yoon DH, Kim KN, Ha Y, Ji GY, Shin DA. Sacral Reconstruction with a 3D-Printed Implant after Hemisacrectomy in a Patient with Sacral Osteosarcoma: 1-Year Follow-Up Result. Yonsei Med J. 2017 Mar;58(2):453-457. doi: 10.3349/ymj.2017.58.2.453.</citation>
    <PMID>28120579</PMID>
  </reference>
  <reference>
    <citation>Wen X, Gao S, Feng J, Li S, Gao R, Zhang G. Chest-wall reconstruction with a customized titanium-alloy prosthesis fabricated by 3D printing and rapid prototyping. J Cardiothorac Surg. 2018 Jan 8;13(1):4. doi: 10.1186/s13019-017-0692-3.</citation>
    <PMID>29310677</PMID>
  </reference>
  <reference>
    <citation>Lu Y, Chen G, Long Z, Li M, Ji C, Wang F, Li H, Lu J, Wang Z, Li J. Novel 3D-printed prosthetic composite for reconstruction of massive bone defects in lower extremities after malignant tumor resection. J Bone Oncol. 2019 Jan 25;16:100220. doi: 10.1016/j.jbo.2019.100220. eCollection 2019 Jun.</citation>
    <PMID>31044134</PMID>
  </reference>
  <reference>
    <citation>Marco, F.A.d., A.Z. Rozim, and S.R. Piedade, Estabilidade articular do joelho no quadro do</citation>
  </reference>
  <reference>
    <citation>Luo W, Huang L, Liu H, Qu W, Zhao X, Wang C, Li C, Yu T, Han Q, Wang J, Qin Y. Customized Knee Prosthesis in Treatment of Giant Cell Tumors of the Proximal Tibia: Application of 3-Dimensional Printing Technology in Surgical Design. Med Sci Monit. 2017 Apr 7;23:1691-1700. doi: 10.12659/msm.901436.</citation>
    <PMID>28388595</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>March 5, 2023</last_update_submitted>
  <last_update_submitted_qc>March 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cho Ray Hospital</investigator_affiliation>
    <investigator_full_name>Hung Do Phuoc, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>bone defect</keyword>
  <keyword>3D-printed Titanium alloy implant</keyword>
  <keyword>Electron Beam Melting</keyword>
  <keyword>customised implant</keyword>
  <keyword>patient-specific implant</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>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</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04449211
org study id: ChoRayH
nct id: NCT04449211
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Functional outcome of the upper limb
time frame: 1 to 12 months
description: 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).
measure: Functional outcome of the lower limb
time frame: 1 to 12 months
description: 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.
measure: Radiological imaging
time frame: Post-operative day 1 to 12 months
description: the bone healing process is evaluated by the change in dual energy CT-scan result
measure: Complications
time frame: through study completion, an average of 1 year.
description: Rate of complications
arm group label: Participants with massive bone defect
arm group type: Experimental
description: 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.
intervention type: Device
intervention name: Implantation
description: Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
arm group label: Participants with massive bone defect
other name: Bone defect implant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hung Do Phuoc, MD, PhD
phone: +84903775579
email: dphungcr@ump.edu.vn
last name: Phu Nguyen Hoang, MD, MSc
phone: +84938689292
email: nguyenhoangphu@ump.edu.vn
facility: 
status: Recruiting
contact: 
contact backup: 
country: Vietnam
citation: Nauth A, McKee MD, Einhorn TA, Watson JT, Li R, Schemitsch EH. Managing bone defects. J Orthop Trauma. 2011 Aug;25(8):462-6. doi: 10.1097/BOT.0b013e318224caf0.
PMID: 21738065
citation: Keating JF, Simpson AH, Robinson CM. The management of fractures with bone loss. J Bone Joint Surg Br. 2005 Feb;87(2):142-50. doi: 10.1302/0301-620x.87b2.15874. No abstract available.
PMID: 15736731
citation: Kironde E, Sekimpi P, Kajja I, Mubiri P. Prevalence and patterns of traumatic bone loss following open long bone fractures at Mulago Hospital. OTA Int. 2019 Mar 12;2(1):e015. doi: 10.1097/OI9.0000000000000015. eCollection 2019 Mar.
PMID: 33937651
citation: Le LC, Blum RW. Road traffic injury among young people in Vietnam: evidence from two rounds of national adolescent health surveys, 2004-2009. Glob Health Action. 2013 Jan 17;6:1-9. doi: 10.3402/gha.v6i0.18757.
PMID: 23336620
citation: Ivers RQ, Nguyen HT, La QN. Status of road safety and injury burden: Vietnam. J Orthop Trauma. 2014;28 Suppl 1:S50-1. doi: 10.1097/BOT.0000000000000098. No abstract available.
PMID: 24858002
citation: Masquelet AC, Begue T. The concept of induced membrane for reconstruction of long bone defects. Orthop Clin North Am. 2010 Jan;41(1):27-37; table of contents. doi: 10.1016/j.ocl.2009.07.011.
PMID: 19931050
citation: Iacobellis C, Berizzi A, Aldegheri R. Bone transport using the Ilizarov method: a review of complications in 100 consecutive cases. Strategies Trauma Limb Reconstr. 2010 Apr;5(1):17-22. doi: 10.1007/s11751-010-0085-9. Epub 2010 Mar 9.
PMID: 20360874
citation: Belthur MV, Conway JD, Jindal G, Ranade A, Herzenberg JE. Bone graft harvest using a new intramedullary system. Clin Orthop Relat Res. 2008 Dec;466(12):2973-80. doi: 10.1007/s11999-008-0538-3. Epub 2008 Oct 8.
PMID: 18841433
citation: Cricchio G, Lundgren S. Donor site morbidity in two different approaches to anterior iliac crest bone harvesting. Clin Implant Dent Relat Res. 2003;5(3):161-9. doi: 10.1111/j.1708-8208.2003.tb00198.x.
PMID: 14575632
citation: Robertson PA, Wray AC. Natural history of posterior iliac crest bone graft donation for spinal surgery: a prospective analysis of morbidity. Spine (Phila Pa 1976). 2001 Jul 1;26(13):1473-6. doi: 10.1097/00007632-200107010-00018.
PMID: 11458153
citation: Campana V, Milano G, Pagano E, Barba M, Cicione C, Salonna G, Lattanzi W, Logroscino G. Bone substitutes in orthopaedic surgery: from basic science to clinical practice. J Mater Sci Mater Med. 2014 Oct;25(10):2445-61. doi: 10.1007/s10856-014-5240-2. Epub 2014 May 28.
PMID: 24865980
citation: Roberts TT, Rosenbaum AJ. Bone grafts, bone substitutes and orthobiologics: the bridge between basic science and clinical advancements in fracture healing. Organogenesis. 2012 Oct-Dec;8(4):114-24. doi: 10.4161/org.23306. Epub 2012 Oct 1.
PMID: 23247591
citation: de Alencar PG, Vieira IF. BONE BANKS. Rev Bras Ortop. 2015 Nov 16;45(6):524-8. doi: 10.1016/S2255-4971(15)30297-4. eCollection 2010 Nov-Dec.
PMID: 27026958
citation: Mauffrey C, Barlow BT, Smith W. Management of segmental bone defects. J Am Acad Orthop Surg. 2015 Mar;23(3):143-53. doi: 10.5435/JAAOS-D-14-00018.
PMID: 25716002
citation: Matsuno H, Yokoyama A, Watari F, Uo M, Kawasaki T. Biocompatibility and osteogenesis of refractory metal implants, titanium, hafnium, niobium, tantalum and rhenium. Biomaterials. 2001 Jun;22(11):1253-62. doi: 10.1016/s0142-9612(00)00275-1.
PMID: 11336297
citation: Rotta, G., T. Seramak, and K. Zasińska, Estimation of Young's Modulus of the Porous Titanium Alloy with the Use of Fem Package. Advances in Materials Science, 2015. 15(4): p. 29 - 37
citation: Elias, C.N., et al., Biomedical applications of titanium and its alloys. JOM, 2008. 60(3): p. 46-49
citation: Heinl P, Muller L, Korner C, Singer RF, Muller FA. Cellular Ti-6Al-4V structures with interconnected macro porosity for bone implants fabricated by selective electron beam melting. Acta Biomater. 2008 Sep;4(5):1536-44. doi: 10.1016/j.actbio.2008.03.013. Epub 2008 Apr 10.
PMID: 18467197
citation: Rho JY, Ashman RB, Turner CH. Young's modulus of trabecular and cortical bone material: ultrasonic and microtensile measurements. J Biomech. 1993 Feb;26(2):111-9. doi: 10.1016/0021-9290(93)90042-d.
PMID: 8429054
citation: Niinomi, M., Mechanical properties of biomedical titanium alloys. Materials Science and Engineering: A, 1998. 243(1): p. 231-236
citation: Head WC, Bauk DJ, Emerson RH Jr. Titanium as the material of choice for cementless femoral components in total hip arthroplasty. Clin Orthop Relat Res. 1995 Feb;(311):85-90.
PMID: 7634595
citation: Shi L, Shi L, Wang L, Duan Y, Lei W, Wang Z, Li J, Fan X, Li X, Li S, Guo Z. The improved biological performance of a novel low elastic modulus implant. PLoS One. 2013;8(2):e55015. doi: 10.1371/journal.pone.0055015. Epub 2013 Feb 21.
PMID: 23437048
citation: Stoppie N, Van Oosterwyck H, Jansen J, Wolke J, Wevers M, Naert I. The influence of Young's modulus of loaded implants on bone remodeling: an experimental and numerical study in the goat knee. J Biomed Mater Res A. 2009 Sep 1;90(3):792-803. doi: 10.1002/jbm.a.32145.
PMID: 18615463
citation: Sumner DR, Turner TM, Igloria R, Urban RM, Galante JO. Functional adaptation and ingrowth of bone vary as a function of hip implant stiffness. J Biomech. 1998 Oct;31(10):909-17. doi: 10.1016/s0021-9290(98)00096-7.
PMID: 9840756
citation: Ryan G, Pandit A, Apatsidis DP. Fabrication methods of porous metals for use in orthopaedic applications. Biomaterials. 2006 May;27(13):2651-70. doi: 10.1016/j.biomaterials.2005.12.002. Epub 2006 Jan 19.
PMID: 16423390
citation: Taniguchi N, Fujibayashi S, Takemoto M, Sasaki K, Otsuki B, Nakamura T, Matsushita T, Kokubo T, Matsuda S. Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment. Mater Sci Eng C Mater Biol Appl. 2016 Feb;59:690-701. doi: 10.1016/j.msec.2015.10.069. Epub 2015 Oct 28.
PMID: 26652423
citation: Sallica-Leva E, Jardini AL, Fogagnolo JB. Microstructure and mechanical behavior of porous Ti-6Al-4V parts obtained by selective laser melting. J Mech Behav Biomed Mater. 2013 Oct;26:98-108. doi: 10.1016/j.jmbbm.2013.05.011. Epub 2013 May 29.
PMID: 23773976
citation: Dallago M, Fontanari V, Torresani E, Leoni M, Pederzolli C, Potrich C, Benedetti M. Fatigue and biological properties of Ti-6Al-4V ELI cellular structures with variously arranged cubic cells made by selective laser melting. J Mech Behav Biomed Mater. 2018 Feb;78:381-394. doi: 10.1016/j.jmbbm.2017.11.044. Epub 2017 Dec 6.
PMID: 29220822
citation: Vasconcellos LM, Leite DO, Oliveira FN, Carvalho YR, Cairo CA. Evaluation of bone ingrowth into porous titanium implant: histomorphometric analysis in rabbits. Braz Oral Res. 2010 Oct-Dec;24(4):399-405. doi: 10.1590/s1806-83242010000400005.
PMID: 21180959
citation: Chang B, Song W, Han T, Yan J, Li F, Zhao L, Kou H, Zhang Y. Influence of pore size of porous titanium fabricated by vacuum diffusion bonding of titanium meshes on cell penetration and bone ingrowth. Acta Biomater. 2016 Mar;33:311-21. doi: 10.1016/j.actbio.2016.01.022. Epub 2016 Jan 21.
PMID: 26802441
citation: Rybicki, F.J., 3D Printing in Medicine: A Practical Guide for Medical Professionals. 2017: Springer. 1 - 22
citation: Zadpoor, A.A., Mechanical meta-materials. Materials Horizons, 2016. 3(5): p. 371-381
citation: Imanishi J, Choong PF. Three-dimensional printed calcaneal prosthesis following total calcanectomy. Int J Surg Case Rep. 2015;10:83-7. doi: 10.1016/j.ijscr.2015.02.037. Epub 2015 Mar 10.
PMID: 25827294
citation: Aranda JL, Jimenez MF, Rodriguez M, Varela G. Tridimensional titanium-printed custom-made prosthesis for sternocostal reconstruction. Eur J Cardiothorac Surg. 2015 Oct;48(4):e92-4. doi: 10.1093/ejcts/ezv265. Epub 2015 Aug 4.
PMID: 26242897
citation: Kim D, Lim JY, Shim KW, Han JW, Yi S, Yoon DH, Kim KN, Ha Y, Ji GY, Shin DA. Sacral Reconstruction with a 3D-Printed Implant after Hemisacrectomy in a Patient with Sacral Osteosarcoma: 1-Year Follow-Up Result. Yonsei Med J. 2017 Mar;58(2):453-457. doi: 10.3349/ymj.2017.58.2.453.
PMID: 28120579
citation: Wen X, Gao S, Feng J, Li S, Gao R, Zhang G. Chest-wall reconstruction with a customized titanium-alloy prosthesis fabricated by 3D printing and rapid prototyping. J Cardiothorac Surg. 2018 Jan 8;13(1):4. doi: 10.1186/s13019-017-0692-3.
PMID: 29310677
citation: Lu Y, Chen G, Long Z, Li M, Ji C, Wang F, Li H, Lu J, Wang Z, Li J. Novel 3D-printed prosthetic composite for reconstruction of massive bone defects in lower extremities after malignant tumor resection. J Bone Oncol. 2019 Jan 25;16:100220. doi: 10.1016/j.jbo.2019.100220. eCollection 2019 Jun.
PMID: 31044134
citation: Marco, F.A.d., A.Z. Rozim, and S.R. Piedade, Estabilidade articular do joelho no quadro do
citation: Luo W, Huang L, Liu H, Qu W, Zhao X, Wang C, Li C, Yu T, Han Q, Wang J, Qin Y. Customized Knee Prosthesis in Treatment of Giant Cell Tumors of the Proximal Tibia: Application of 3-Dimensional Printing Technology in Surgical Design. Med Sci Monit. 2017 Apr 7;23:1691-1700. doi: 10.12659/msm.901436.
PMID: 28388595
responsible party type: Principal Investigator
investigator affiliation: Cho Ray Hospital
investigator full name: Hung Do Phuoc, MD, PhD
investigator title: Associate Professor
sharing ipd: No
ipd description: 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