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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04449211
Other study ID # ChoRayH
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date June 1, 2023
Est. completion date December 30, 2023

Study information

Verified date March 2023
Source Cho Ray Hospital
Contact Hung Do Phuoc, MD, PhD
Phone +84903775579
Email dphungcr@ump.edu.vn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 30, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Vietnam Cho Ray hospital Ho Chi Minh

Sponsors (3)

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

Country where clinical trial is conducted

Vietnam, 

References & Publications (39)

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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. — View Citation

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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. — View Citation

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Elias, C.N., et al., Biomedical applications of titanium and its alloys. JOM, 2008. 60(3): p. 46-49

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Marco, F.A.d., A.Z. Rozim, and S.R. Piedade, Estabilidade articular do joelho no quadro do

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. — View 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. — View Citation

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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. — View Citation

Niinomi, M., Mechanical properties of biomedical titanium alloys. Materials Science and Engineering: A, 1998. 243(1): p. 231-236

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. — View 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. — View 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. — View Citation

Rotta, G., T. Seramak, and K. Zasinska, 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

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. — View Citation

Rybicki, F.J., 3D Printing in Medicine: A Practical Guide for Medical Professionals. 2017: Springer. 1 - 22

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Zadpoor, A.A., Mechanical meta-materials. Materials Horizons, 2016. 3(5): p. 371-381

* Note: There are 39 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Functional outcome of the upper limb 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). 1 to 12 months
Primary Functional outcome of the lower limb 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. 1 to 12 months
Primary Radiological imaging the bone healing process is evaluated by the change in dual energy CT-scan result Post-operative day 1 to 12 months
Secondary Complications Rate of complications through study completion, an average of 1 year.
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