MAJOR PROJECT SYNOPSIS

DESIGN & DEVELOPMENT OF Mg-ALLOY

BASED BIO-DEGRADABLE BONE SCAFFOLD

Punjab Engineering College, Chandigarh

Group 12: Mentor:

Kshitiz Sharma- 20107003 Dr. Kamal Kumar

Arihan Jain- 20107001 Mechanical Engineering Deptt.

Aryan Verma- 20107058

Gursharan Kaur- 20107015

Introduction
Bone tissue engineering is a multidisciplinary field that combines principles from biology,
engineering, and medicine to develop strategies for regenerating or repairing damaged bone
tissue. This approach aims to provide solutions for bone defects resulting from various causes,
such as trauma, congenital abnormalities, infection, and diseases like osteoporosis.
Scaffolds are three-dimensional structures that serve as templates for new bone tissue formation.
They provide a framework for cells to adhere, proliferate, and differentiate. Scaffolds can be
made from a variety of materials, including polymers, ceramics, and natural materials like
collagen. The choice of material depends on factors such as biocompatibility, mechanical
properties, and degradation rate.

The process of bone tissue engineering generally involves seeding cells onto scaffolds, culturing
them under appropriate conditions iKn bioreactors, and then implanting the engineered construct
into the patient's body. The ultimate goal is for the engineered tissue to integrate with the
surrounding native bone tissue, providing structural and functional restoration.
While significant progress has been made in bone tissue engineering, challenges remain,
including achieving optimal vascularization of the engineered tissue, ensuring long-term
mechanical stability, and addressing potential immune responses. Researchers continue to
explore innovative approaches to improve the outcomes of bone tissue engineering and make it a
viable clinical option for patients with bone defects or injuries.

In any study involving Bone Tissue engineering, focus is either given to the geometry of the
scaffolds or its material. In our project, we will be discussing the degradation behavior of the
scaffolds with respect to their geometry, as the material chosen is an alloy of magnesium.

The role of scaffold geometry is crucial in bone tissue engineering as it directly influences the
development, growth, and functionality of engineered bone tissue. In bone tissue engineering,
scaffolds are three-dimensional structures designed to support and guide the regeneration of bone
tissue. The scaffold serves as a temporary framework that provides a physical structure for cells
to attach, proliferate, differentiate, and ultimately form new bone tissue. The geometry of the
scaffold plays a significant role in achieving successful bone regeneration. Here's how scaffold
geometry affects bone tissue engineering: mechanical support, cell attachment and migration,
nutrient diffusion and waste removal, osteogenic differentiation, vascularization, bone ingrowth
and integration, and mineralization.

Materials play a crucial role in bone tissue engineering scaffolds as they form the structural
foundation upon which new bone tissue can be regenerated. The choice of materials for scaffolds
is critical to ensure biocompatibility, mechanical stability, and the ability to support cell
adhesion, proliferation, and differentiation. The material selected for the scaffold decides several
important properties of the final scaffolds such as degradation rate, pore structure, surface
properties, Osteoconductivity, controlled release of growth factors, and the fabrication
techniques used.

Why Magnesium?
There are three categories of materials for use as implants -
Metals
Ceramics
Polymers

Metal-based implants provide remarkable mechanical strength, a prerequisite for manufacturing

an orthopedic implant. Research efforts have focused on developing metal-based low-cost,
biodegradable, low-density, high mechanical strength, and highly bioactive implants. Mg
(Magnesium) is a near-ideal material easily degraded in biological environments. The density of
Magnesium is 1.74 g/cm3. It is lighter than aluminum and steel, but its mechanical properties are
equivalent. Also, due to its damping capability, it improves bone implant capability. Magnesium
is relatively abundant in the human body, constituting about 0.5g/kg of human weight. The daily
requirement of Mg is 375 mg and is considered a cofactor for various enzymes that participate in
the metabolism.

The high biocompatibility of Mg is quite significant:

1. Due to its digestive nature under the influence of bodily fluids, Magnesium degrades with
time, and due to its limited persistence, it avoids the need for a second surgery
2. It also enhances bone healing by reducing the stress-shielding phenomenon.
3. It has antimicrobial properties that help prevent infection during recovery.
4. Mg ions Mg2+ are well known for their tissue healing process, and excess presence of Mg2+
does not cause any cytotoxicity; instead, Mg2+ is excreted through urine.

The choice of materials for bone tissue engineering scaffolds significantly influences the
scaffold's biocompatibility, mechanical properties, degradation behavior, and ability to support
cell growth and differentiation. Researchers continue to innovate in materials design to create
scaffolds that closely mimic the natural bone environment and promote successful tissue
regeneration.
In summary, scaffold geometry in bone tissue engineering plays a critical role in determining the
success of tissue regeneration. A well-designed scaffold with appropriate pore sizes,
interconnectivity, and mechanical properties can provide the necessary support for cell
attachment, proliferation, differentiation, and ultimately the formation of functional bone tissue.
Researchers in the field carefully consider scaffold geometry to optimize bone tissue engineering
strategies for various clinical applications.
Research gap
Bone tissue engineering is a rapidly evolving field that aims to develop strategies to repair and
regenerate bone tissue using a combination of biomaterials, cells, and growth factors. Research
in this field has made significant progress, but there are still several research gaps and challenges
that researchers are actively working to address. Some research gaps in bone tissue engineering
include:

1. Biomimetic Scaffold Design: While there are various biomaterials used as scaffolds for
bone tissue engineering, there is still room for improvement in designing scaffolds that
closely mimic the natural extracellular matrix of bone. Researchers are exploring ways to
create scaffolds that have the right mechanical properties, pore structure, and biochemical
cues to enhance cell attachment, proliferation, and differentiation.
2. Mechanical Stimulation and Loading: Bone tissue is responsive to mechanical forces,
which play a significant role in bone remodeling and maintenance. Designing bioreactors
and culture systems that can apply appropriate mechanical stimulation to engineered
constructs in a controlled manner is an ongoing challenge.
3. Immunomodulation and Immune Response: The immune response to implanted
biomaterials and engineered constructs can impact tissue regeneration. Researchers are
investigating ways to modulate the immune response to promote tissue integration and
reduce the risk of rejection or adverse reactions.
4. Clinical Translation: While there have been promising advancements in the lab,
translating these findings into clinically viable therapies remains a challenge. Researchers
need to navigate regulatory pathways and demonstrate the safety and efficacy of their
approaches in clinical trials.
5. Long-Term Durability and Functionality: Ensuring that the regenerated bone tissue
maintains its structural integrity, functionality, and strength over the long term is a
critical consideration. Long-term studies are needed to assess the durability and
biomechanical properties of engineered bone tissue.
6. Personalized Approaches: Every patient's bone regeneration needs can be unique.
Developing personalized approaches that consider factors such as patient age, health
condition, and the specific location and size of the bone defect is an area of ongoing
research.
7. Combination Therapies: Researchers are exploring the potential of combining different
approaches, such as incorporating growth factors, gene therapy, and bioactive molecules,
to enhance the effectiveness of bone tissue engineering strategies.

Objectives
- Design scaffolds of different geometries in a CAD software
- Finite element analysis of the designed scaffolds to analyze their mechanical properties
- Fabrication of the designed scaffolds by various manufacturing techniques
 - To observe the degradation behavior and hydrogen evolution in SBF
- Test the degraded scaffold samples for mechanical properties

Methodology:
Design, Analysis, Fabrication, and Testing of Scaffolds for Mechanical and Degradation
Properties

1. Design of Scaffolds in CAD Software: Identify the desired scaffold geometries (e.g.,
cubic, cylindrical, porous structures). Create 3D models of scaffolds based on chosen
geometries with specified dimensions and pore sizes using Solidworks software.
Incorporate structural features such as struts, connections, and pore arrangements.
2. Finite Element Analysis (FEA) of Scaffold Designs: Import scaffold CAD models into
FEA software i.e., ANSYS. Define material properties (e.g., Young's modulus, Poisson's
ratio) based on scaffold material. Apply appropriate boundary conditions to mimic real-
world loading scenarios. Perform FEA simulations to analyze mechanical properties (e.g.,
stress distribution, deformation, failure points).
3. Fabrication of Scaffold Designs: Choose appropriate manufacturing techniques based on
scaffold material and complexity, in our case turning using a lathe machine and drilling
using an EDD. Post-process fabricated scaffolds (e.g., cleaning, curing) as required by
the manufacturing method.
4. Degradation Behavior and Hydrogen Evolution in Simulated Body Fluid (SBF): Immerse
scaffold samples in SBF to simulate physiological conditions. Monitor degradation over
time through weight loss measurements and visual observations. Collect and analyze
hydrogen gas evolution to assess biocompatibility and corrosion effects.
5. Mechanical Testing of Degraded Scaffold Samples: Extract scaffold samples from SBF at
predetermined degradation intervals. Perform mechanical tests (e.g., tensile,
compression) on degraded samples using a universal testing machine. Measure
mechanical properties such as tensile strength, compressive modulus, and fracture
toughness. Compare mechanical properties of degraded scaffolds with initial properties to
evaluate degradation effects.

References
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Bioactive Materials, Volume 3, Issue 3, 2018, Pages 278-314
2. R.J. O'Keefe, J. Mao, Bone tissue engineering and regeneration: from discovery to the clinician
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3. S. Bose, M. Roy, A. Bandyopadhyay, Recent advances in bone tissue engineering scaffolds,
Trends Biotechnol. 30 (10) (2012) 546e554.
4. S. Wu, et al., Biomimetic porous scaffolds for bone tissue engineering, Mater. Sci. Eng. R Rep.
80 (2014) 1e36.
5. M.J. Webber, et al., A perspective on the clinical translation of scaffolds for tissue engineering,
Ann. Biomed. Eng. 43 (3) (2015) 641e656.
6. Additively manufactured pure zinc porous scaffolds for critical-sized bone defects of rabbit
femur, Dandan Xia et al., Bioactive Materials, Volume 19, 2023, Pages 12-23
7. 3D printing method for bone tissue engineering scaffold, Qiliang Zhang et al., Medicine in
Novel Technology and Devices, Volume 17, 2023