KEMENTERIAN PENDIDIKAN TINGGI
MINISTRY OF HIGHER EDUCATION
MALAYSIA
PRGS FASA 1 TAHUN 2017
PRGS/1/2017/TK03/UKM/02/2
Prototype development and animal (pre-clinical) study of Titanium Alloy/Hydroxyapatite fixator screw using novel material of composite through Powder Injection Molding for orthopaedic implant
Research Domain: Technology & Engineering
Sub Domain: Mechanical & Manufacturing
PROJECT LEADER
Prof. Ir. Dr. Abu Bakar Bin Sulong
Professor
Department of Mechanical & Manufacturing
Faculty of Engineering and Bulit Environment
Universiti Kebangsaan Malaysia
abubakar@ukm.edu.my
RESEARCH MEMBERS
NO NAME INSTITUTION FACULTY/SCHOOL/ CENTRE/UNIT
1 Assoc. Prof. Dr. Abdul Halim Abd Rashid UKM Faculty of Medicine
2 Assoc. Prof. Dr. Ng Min Hwei UKM Faculty of Medicine
3 Prof. Dr. Norhamidi Muhamad UKM Faculty of Engineering & Bulit Environment
4 Assoc. Prof. Dr. Roslinda binti Shamsudin UKM Faculty of Engineering & Bulit Environment
5 Dr. Farhana Binti Mohd Foudzi UKM Faculty of Engineering & Bulit Environment
6 Dr. Shiplu Roy Chowdhury UKM Faculty of Medicine
RESEARCH DURATION
2 years (15 August 2017 - 14 August 2019)
RESEARCH ABSTRACT
Implants are the most common option for repairing bone fractures where fixator plates and screws made from titanium alloys (Ti- alloy) and stainless steel (SS) are widely available in the orthopedic market. Although Ti-alloy implants perform better than SS implants due to their mechanical properties that are similar to that of bone and have better resistance towards infection, patients tend to use SS implants due to their lower price. In terms of permanent-ability of implants, it depends on requests and conditions of patients where sometimes the implants initiate swelling and infection due to continued friction (mobile) between the implants and tendons of patients. The current commercialized implants are coated with a thin layer of HA for the biocompatibility purpose. In our previous FRGS work, we have obtained promising results from the in-vitro studies using injected Ti-alloy/HA composite using powder injection molding (PIM) process. Such composite shows efficient performance especially on the biocompatibility with the living tissue which is widely reported. We found that the sintered Ti-alloy/HA induced nucleation and growth of Ca-P phase that helps to generate bone growth. Pre-clinical studies were performed as a working material prototype of new material in orthopedics, and it did not show negative results to the host (animal rabbit). In this work, prototypes of fixator screws were also fabricated by powder injection molding process. Early tests on artificial bone show the strength is not enough. Change of design of screw and drilling procedure will make this successful. Such material Ti-alloy/HA prototypes were tested in terms of its immunomodulation of stem cells seeded. In addition, the rate of bone growth and dissolution of such prototypes using animal models such as New Zealand white rabbits will also be evaluated, showing promising results as compatible and bioactive material. It is highly expected that the cost of implants will be greatly reduced by the PIM process and has higher durability (longer performance) than the existing commercialized screw implants.
RESEARCH OBJECTIVES
  1. To design and fabricate a working prototype (fixator screw) made of Ti-alloy/HA composite through powder injection molding (PIM) for orthopedic application (knee surgery), and to test its reliability in terms of mechanical mechanism on artificial bone.
  2. To conduct animal (pre-clinical) studies on the immune reaction, dissolution and bone growth profile of stem cells seeded on the fixator screw prototype (Ti-alloy/HA) using animal models.
  3. To analyse the post harvested bone of the stem cells seeded on the fixator screw prototype (Ti-alloy/HA) from animal models.
RESEARCH INFOGRAPHIC
RESEARCH OUTPUT
  1. Intellectual Property (IP) :
    Proposed Achieve
    1 1

    • Patent No. PI2019007820 (OSA Technology Sdn Bhd)
  2. Product/Prototype:
    • MyScrew 1.0 : Medical grade screws for implant of bones (cortical and cancellous bone). Screw will be used to hold broken/fracture bones.
RESEARCH IMPACT
  1. Economy : will create a new market segment, which will become a niche area for Malaysia in terms of the medical industry (parallel with KEGA 3 and SDG 9).
  2. Society : with a green manufacturing process (PIM) and reduction of implant cost will improve the well -being of society in terms of healthcare in terms of orthopedic problems.
  3. Nation : will make Malaysia among high-tech and green manufacturing hubs for medical implants.
APPENDIX
VIDEO
 
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