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
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
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 |
2 years (15 August 2017 - 14 August 2019)
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.
-
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.
-
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.
-
To analyse the post harvested bone of the stem cells seeded on the
fixator screw prototype (Ti-alloy/HA) from animal models.
-
Intellectual Property (IP) :
- Patent No. PI2019007820 (OSA Technology Sdn Bhd)
-
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.
-
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).
-
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.
-
Nation : will make Malaysia among high-tech and green
manufacturing hubs for medical implants.