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A REPORT

ON

OPTIMIZATION OF BONE CUTTING COVERAGE FOR A


ROBOTIC KNEE SURGERY USING
COMPUTER AIDED ANALYSIS AND STATISTICAL METHODS

BY

Rachit Saxena
2018HT30032

AT

Stryker Global Technology Center, Gurgaon

BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI


April 2020
A REPORT

ON

OPTIMIZATION OF BONE CUTTING COVERAGE FOR A


ROBOTIC KNEE SURGERY USING
COMPUTER AIDED ANALYSIS AND STATISTICAL METHODS

BY

Rachit Saxena

2018HT30032

Prepared in partial fulfilment of


M.Tech. Design Engineering degree programme
AT

Stryker Global Technology Center, Gurgaon

BIRLA INSTITUTE OF TECHNOLOGY & SCIENCE, PILANI


April 2020
ACKNOWLEDGEMENTS

I would like to take this opportunity to thank Mr. Pankaj Vyas (Senior Director – Joint

Replacement SGTC) for believing in me and giving me approval to go ahead for this Master of

Technology Degree in Design Engineering. I would also like to thank Mr. Aman Arora (Manager

– Product Development) for always encouraging me towards achieving this goal. A special

thanks to Md. Rehan (Manager – Primary Knee PD) for giving me proper guidance and providing

resources in timely manner so that I can do research and complete my M. Tech with sincerity.

I would like to thank Dr. Benu Madhab Gedam for his mentorship throughout this research

work and his valuable comments which helps in improvising this report and bringing the best

output out of this work.

Finally, I would like to thank my parents, friends and colleagues for their true support

during this entire course and invaluable suggestions which helped me a lot.
BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCE
PILANI (RAJASTHAN)
WILP Division

Organization: Stryker Global Technology Center Location: Gurgaon

Duration: 2 Months and 2 Weeks Date of Start: 16/Jan/2020

Date of Submission: 30/Mar/2020

Title of the Project: Optimization of Bone Cutting Coverage for a Robotic Knee Surgery using

Computer Aided Analysis and Statistical Methods

ID No. / Name of the student: 2018HT30032 / Rachit Saxena

Name (s) and Designation (s) of Md. Rehan and Aman Arora
your Supervisor and Additional Examiner: (Manager) (Manager)

Name of the
Faculty mentor: Benu Madhab Gedam

Keywords: Anatomical Axis, Computer Aided Analysis, Functional Axis, Haptics, Mako Robot,
Mechanical Axis, Robotic Surgery, Statistical Analysis, Total Knee Arthroplasty

Project Areas: Computer Aided Analysis & Design

Abstract: The Robotic Surgery in the field of Joint Replacement is very helpful for surgeon as it
ensures the protection of various soft tissues around the joint (Knee Joint and Hip Joint) as well
as the accuracy of bone cuts is superior to the manual preparation. This study aims to further
optimize the bone coverage area for Total Knee Arthroplasty based on the CT scan database of
multiple bones collected by Stryker over a long range of time. The study utilizes the concepts of
Computer Aided Designing to mimic the bone cuts which are made by surgeon, on the CT bone
database and then perform the statistical analysis on the data collected.
In order to perform this study various tools would be used, one important tool is SOMA which
means Stryker Orthopedics Modelling and Analytics. SOMA contains a huge database of CT
scans of bones and also allows user to create various features on the bone models. After
creation of features, the user can create measurement dimensions which further can be exported
in the Excel worksheet. Other CAD tool to be used is PTC Creo and for carrying out statistical
analysis Minitab would be used.

After the data collection, we would perform the statistical analysis on the data and based on the
result of the analysis the bone coverage area can be estimated. In parellel to the bone coverage
area, the shape of the cut can also be determined. The calculated area and the estimated shape
of cut would help us in optimizing the Bone Cutting Coverage and also it will very helpful in
determining the tool path for the motion of robotic arm. While working on this project, we would
also study various research papers and consider them for building our work.

The outcome of this study will result in even better performance of the future robotic surgery by
ensuring the proper bone coverage of the patient. Also it would furthur enhance the safety of the
surgery as no soft tissues are damaged or the soft tissue damage would be minimized. The
optmized bone cutting coverage will enhance the accuracy of the surgery which will help the
patient for a better functional outcome of the Total Knee Arthroplasty and faster recovery.

E-Mail Approval attached E-Mail Approval attached


at the End of Report
_________________ at the End of Report
________________________
Signature of Student Signature of your Supervisor

Name: Rachit Saxena Name: Md. Rehan

Date: Apr 06, 2020 Date: Apr 06, 2020

Place: Gurgaon Place: Gurgaon


TABLE OF CONTENTS

1. INTRODUCTION .............................................................................................................. 11

2. CHAPTER 1: KNEE ANATOMY AND JOINT MOTION.................................................... 16

3. CHAPTER 2: STRYKER ORTHOPEDICS MODELING AND ANALYTICS ...................... 22

4. CHAPTER 3: RESEARCH AIMS ..................................................................................... 27

5. CHAPTER 4: MATERIALS AND METHODS ................................................................... 29

6. CHAPTER 5: RESULTS................................................................................................... 40

7. CONCLUSIONS AND RECOMMENDATIONS ................................................................ 47

8. APPENDIX – I: NORMAL DISTRIBUTION THEORY ....................................................... 51

9. APPENDIX – II: BASIC THREE-DIMENSIONAL TRANSFORMATIONS......................... 53

10. REFERENCES ................................................................................................................. 56

11. GLOSSARY ..................................................................................................................... 59


TABLE OF FIGURES

Figure 1: Bones of Knee Joint .................................................................................................. 11

Figure 2: Progression of Osteoarthritis ..................................................................................... 12

Figure 3: Knee Joint with Prosthesis ........................................................................................ 13

Figure 4: Stryker Robotic Platform - Mako ............................................................................... 14

Figure 5: Haptic Guided Arm Motion ........................................................................................ 15

Figure 6: Planes of Body .......................................................................................................... 16

Figure 7: Directional Reference of Body................................................................................... 17

Figure 8: Bones of Knee Joint .................................................................................................. 18

Figure 9: Ligaments and Menisci ............................................................................................. 18

Figure 10: Quadriceps Muscles ................................................................................................ 19

Figure 11: Hamstring Muscles .................................................................................................. 19

Figure 12: Landmarks of Femur ............................................................................................... 19

Figure 14: Landmarks of Patella .............................................................................................. 20

Figure 13: Landmarks of Tibia .................................................................................................. 20

Figure 15: Axes of Knee ........................................................................................................... 20

Figure 16: Arcs of Motion ......................................................................................................... 21

Figure 17: Shape of Femur ...................................................................................................... 21

Figure 18: Shape of Tibia ......................................................................................................... 21


Figure 19: Screenshot of SAAT ................................................................................................ 23

Figure 20: Screenshot of BODAMAT ....................................................................................... 23

Figure 21: Screenshot of Bone Database Pilot ........................................................................ 24

Figure 22: Screenshot of SIFT ................................................................................................. 25

Figure 23: Screenshot of DeViT ............................................................................................... 25

Figure 24: Screenshot of SIST ................................................................................................. 26

Figure 25: Number of Bones Per Size of Triathlon Implant ...................................................... 28

Figure 26: Anderson Darling Normality Test for Number of Bones .......................................... 28

Figure 27: Triathlon Femoral Component Views and Five Resections ..................................... 29

Figure 28: Distal Resection Setup on SOMA ........................................................................... 30

Figure 29: Posterior Resection Setup on SOMA ...................................................................... 31

Figure 30: Gap Balance between Femur and Tibia through Range of Motion .......................... 31

Figure 31: Five Resection Planes on Femur in Sagittal View ................................................... 32

Figure 32 A to E: Intersection of Resection Plane and Bone Models for Anterior, Anterior

Chamfer, Distal, Posterior Chamfer and Posterior Resection .................................................. 33

Figure 33: Points Marked on Anterior Resection Shape........................................................... 34

Figure 35: Points Marked on all Five Resection Shapes (View 2) ............................................ 35

Figure 34: Points Marked on all Five Resection Shapes (View 1) ............................................ 35

Figure 36: Bar Chart of Number of Points Per Resection for Each Implant Size ...................... 36

Figure 37: Data for Anterior Resection from SOMA ................................................................. 37


Figure 38: Data for Anterior Chamfer Resection from SOMA ................................................... 37

Figure 39: Data for Distal Resection from SOMA ..................................................................... 38

Figure 40: Data for Posterior Chamfer Resection from SOMA ................................................. 38

Figure 41: Data for Posterior Resection from SOMA ............................................................... 39

Figure 42: Existing Haptic for Anterior Resection ..................................................................... 40

Figure 44: Existing Haptic for Distal Resection ........................................................................ 41

Figure 43: Existing Haptic for Anterior Chamfer Resection ...................................................... 41

Figure 46: Existing Haptic for Posterior Resection ................................................................... 42

Figure 45: Existing Haptic for Posterior Chamfer Resection .................................................... 42

Figure 47: Existing Haptic for Five Resections of Femur.......................................................... 43

Figure 49: Existing Haptic in Yellow and New Haptic in Pink

For Anterior Chamfer Resections ............................................................................................. 44

Figure 48: Existing Haptic in Yellow and New Haptic in Pink

For Anterior Resections............................................................................................................ 44

Figure 51: Existing Haptic in Yellow and New Haptic in Pink

For Posterior Chamfer Resections ........................................................................................... 45

Figure 50: Existing Haptic in Yellow and New Haptic in Pink

For Distal Resections ............................................................................................................... 45

Figure 52: Existing Haptic in Yellow and New Haptic in Pink

For Posterior Resections .......................................................................................................... 46


Figure 53: Change in Haptic for Anterior Resection in Pink ..................................................... 48

Figure 55: Change in Haptic for Distal Resection in Pink ......................................................... 49

Figure 54: Change in Haptic for Anterior Chamfer Resection in Pink ....................................... 49

Figure 56: Change in Haptic for Posterior Chamfer Resection in Pink ..................................... 49

Figure 57: Change in Haptic for Posterior Resection in Pink.................................................... 50

Figure 58: Normal Distribution Curve with 68-95-99.7 rule....................................................... 51

Figure 59: Scaling Transformation ........................................................................................... 53

Figure 60: Translation Transformation ..................................................................................... 54

Figure 61: Rotation Transformation .......................................................................................... 55


INTRODUCTION

The human body is made up of many joints which helps humans in performing many

complex motions. One such important joint is Knee Joint which is a very crucial joint for carrying

out many day-to-day activities like walking, running, sitting, squatting, cycling etc. In every joint

there is a relative motion between two bones. Since bones are hard from surface and in order

to avoid direct contact of bone to bone, they are covered with soft material known as cartilages

which helps in smooth relative motion.

In normal knee joint there are three bones involved which are femur, tibia and patella.

There is a relative motion between tibia and femur known as tibiofemoral compartment and

between patella and femur known as patellofemoral compartment. There is also a fourth bone

known as fibula which does not takes part in relative motion.

Figure 1: Bones of Knee Joint


When there is relative motion between bones then it causes some wear and tear in the

cartilages, but body heals itself and restores back the cartilages. When the rate of healing

decreases then it develops a disease known as Osteoarthritis. However, there are several

factors that can lead to osteoarthritis, some of the major factors are age, weight, heredity,

gender, repetitive stress injuries, athletics etc.

When osteoarthritis develops in the normal knee, it leads to direct bone to bone contact

which in turn causes severe knee pain and restricts the normal range of motion of the joint. While

there are some conservative treatment options available that may slow down the progression of

disease, but if pain becomes very severe then a knee surgery may be required.

Figure 2: Progression of Osteoarthritis

The osteoarthritis knee disease is cured by the surgery of Total Knee Arthroplasty, in

which the affected portion of the knee is removed, and the joint is replaced by the prosthesis.

Conventionally the surgery is performed manually by orthopedic surgeons using surgical

instruments which require great skill and expertise. Recently the total knee arthroplasty is also
performed using Robotics and Stryker is a world leader in performing Robotic Total Knee

Arthroplasty with their robotic platform Mako.

Figure 3: Knee Joint with Prosthesis

In Robotic Total Knee Arthroplasty, a Computed Tomography Scan (CT scan) of the

patient is taken. A 3D segmentation of the joint is created with the CT scan and the prothesis is

planned on Computer System. This plan is then loaded to the Robotic System and the robotic

arm thus performs the surgery.

Mako Robotic Platform is guided by haptics, that are boundaries in 2D planes which

constraint the motion of arm within the specified limits. The orientation, location and shape of
haptics provides the accuracy to the resections of bone and at the same time ensures the safety

to the soft tissues around the resection. Due to this haptic guided motion the overall time of the

surgery also reduces.

Figure 4: Stryker Robotic Platform - Mako

In this project, I am focusing on optimizing the limits or bone cutting coverage of the

haptics for the Robotic Knee Surgery. With this optimization, we can ensure the proper bone

coverage for the resection and it will also further enhance the safety of the soft tissues. In order

to optimize the bone cutting coverage, I have collected the data on a large set of bones using

computer aided analysis and then performed the statistical analysis on the data which further

gives us the new limits which are data driven. These new limits or new haptics are then modeled

in the CAD software and then compared with the existing haptics. The percentage change is

calculated using computer aided analysis.


Figure 5: Haptic Guided Arm Motion

The testing of the new haptics is still under evaluation and once we ensure that the new

design of haptic is significantly better than the existing haptics then the existing haptics will be

revised to new haptics. As part of future scope for this project one can evaluate the performance

of existing haptic over the new haptic and can evaluate the benefits of the optimized haptics.

Also, the optimization is considered only for femoral resection for this project, in future this same

approach can be utilized for the optimization of tibial resection too.


CHAPTER 1

KNEE ANATOMY AND JOINT MOTION

In the first chapter, we will focus on the Anatomy of Knee and the various motion

performed by the knee joint. Before we go deep into the anatomy, let us focus on some basic

terminology used in the field of medical domain.

The human body is divided by three planes and they are known by:

1. Frontal Plane: This plane divides the body into front and back halves.

2. Sagittal Plane: This plane divides the body into left and right halves.

3. Transverse Plane: The plane separates the body into top and bottom halves.

Figure 6: Planes of Body


Apart from the planes, there are some directional references also exists which are known as:
1. Anterior: Front side of the body

2. Posterior: Back side of the body

3. Medial: Towards the midline of the body

4. Lateral: Away from the midline of the body

5. Proximal: Nearer to the center of the body

6. Distal: Away from the center of the body

7. Superior: Towards the head of the body

8. Inferior: Towards the feet of the body

Figure 7: Directional Reference of Body

After the study of planes and directional references of body, let us now focus on the Knee

Joint and various parts that constitute it. The knee joint is a complex hinge type synovial joint

which supports the complete weight of the body. The Knee Joint has four bones out of which
three bones takes part in articulation (relative motion). The stability to knee joint is performed by

four ligaments and the congruency throughout the motion of joint is maintained by Menisci. The

knee joint performs its motion due to set of muscles group and these muscles group is connected

to bone via Tendon. The joint capsule is surrounded by a fluid known as Synovial Fluid which

provides the lubrication to the motion of knee joint.

The Bones of Knee Joint are as follows:

1. Femur (Thigh Bone)

2. Tibia (Shin Bone)

3. Patella (Kneecap)

4. Fibula (Does not takes part in articulation)

The Ligaments of Knee Joint are as follows: Figure 8: Bones of Knee Joint

1. Collateral Ligaments

a. Medial Collateral Ligament

b. Lateral Collateral Ligament

2. Cruciate Ligaments

a. Anterior Cruciate Ligament

b. Posterior Cruciate Ligament

The Menisci of Knee Joint are as follows:

1. Medial Meniscus Figure 9: Ligaments and Menisci

2. Lateral Meniscus
The muscles group of Knee Joint are as follows:

1. Quadriceps Femoris (For Extension of the Knee)

a. Rectus Femoris

b. Vastus Lateralis

c. Vastus Medialis

d. Vastus Intermedius
Figure 10: Quadriceps Muscles

2. Hamstring (For Flexion of the Knee

a. Biceps Femoris

b. Semitendinosus

c. Semimembranosus

Figure 11: Hamstring Muscles

The three articular bones of Knee Joint also have some major landmarks and for the sake

of understanding about this project, it is worthwhile to have a look on these landmarks on bones.

The landmarks on Femur is shown in Figure 12, the landmarks on Tibia is shown in Figure 13

and the landmarks on Patella is shown in Figure 14.

Figure 12: Landmarks of Femur


Figure 13: Landmarks of Tibia Figure 14: Landmarks of Patella

After the understanding of Knee Anatomy, now let us try to focus on the motion of Knee

Joint. The Knee Joint is a complex joint and it performs three types of motion – rolling, rotation

and sliding/translation. In order to understand the motion of joint and learn about how it moves

we must break it down into a series of Axes, Arcs and Shapes.

The Knee Joint have three major axes:

1. Anatomical Axis: This is the axis of the bone which is

depicted by RED color axis in Figure 15.

2. Mechanical Axis: This is the axis of alignment which is

depicted by BLUE color axis in Figure 15. The body

weight passes through this axis.

3. Functional Axis: This is the axis about which the limb

rotates which is depicted by GREEN color in Figure 15.

This axis is also known as Flexion-Extension axis. Figure 15: Axes of Knee
The Knee Joint have three Arcs of motion:
1. Screwhome Arc:
As the Knee Extends the femur internally rotates
with reference to the tibia. It is described as Passive
motion

2. Functional Arc:
As the Knee Flexes 10° the femur externally rotates
with reference to the tibia through 120°. It is
described as Active Motion

3. Deep Flexion Arc:


As the Knee Flexed beyond 120° the femur
externally rotates with reference to tibia and
posteriorly translates. It is a Passive Motion.
Figure 16: Arcs of Motion

The shapes of knee joint compliments the axes. If something rotates then body design

that to be round and the axis is the center of rotation. The shape of posterior condyles of femur

have circular geometry when it performs functional flexion from 10° to 110°~120°. (Figure 17)

On the other side the shape of tibia is simpler to understand. On tibia the medial plateau is

concave in shape and lateral plateau is convex in shape. (Figure 18)

Figure 17: Shape of Femur

Figure 18: Shape of Tibia


CHAPTER 2

STRYKER ORTHOPEDICS MODELING AND ANALYTICS (SOMA)

After a basic understanding of Knee anatomy and how it performs motion, let’s move

towards the new aspect of our project. As part of optimization we need to have good amount of

bone data that can be used for analysis. For this role, in Stryker, we have a very good and

indigenously developed software suite known as SOMA (Stryker Orthopedics Modeling and

Analytics). SOMA has many applications for analysis on Bones. It is a big database of 3D models

of bones which are segmented out of CT scans.

SOMA suite involves the following applications:

1. SAAT – Stryker Anatomy Analysis Tool:

This is the main tool of SOMA suite. This tool helps the user to create various

constructions (planes, lines, points, etc.) on a bone model using pre-defined

landmarks and user-defined points. A series of transformations is used for the

mapping of constructions from a template bone to every other bone in the database.

This feature allows the user to quantitatively evaluate the morphology of all bones in

the database. This methodology provides the user with a means to accurately,

repeatedly, and efficiently assess bone morphology. The bone morphology

measurements can be analyzed in SAAT as well as it can also be exported to an Excel

spreadsheet for further analysis.


Figure 19: Screenshot of SAAT

2. BODAMAT – Bone Database Management Tool:

This tool gives identification to the user that which bone segments are available for

each patient in the database and it also let the user to select a subgroup of these

patients from which an average model of STereoLithography (STL) and average

Digital Imaging and COmmunications in Medicine (DICOM) image set can be created.

Figure 20: Screenshot of BODAMAT


3. PILOT – Bone Database Pilot:

This tool is used to present radiographic projections of all CT scans in the SOMA

database which can quickly allow the user to assess patients with implants, specific

disease states, etc.

Figure 21: Screenshot of Bone Database Pilot

4. SIFT – Stryker Implant Fitting Tool:

This tool allows the user to align an implant on a bone and automatically determine

the potential best fit in a region of interest. This allows the user to quickly evaluate

several design iterations determining the best fit for the entire population.
Figure 22: Screenshot of SIFT

5. DeViT – Density Visualization Tool:

This tool allows the user to utilize constructions, as defined for SAAT, in order to create

regions of interest where the bone density based on Hounsfield Unites (HU) can be

visualized and measured. This information can be analyzed in DeViT, as well as

exported to Excel for post-processing.

Figure 23: Screenshot of DeViT


6. SIST – Stryker Implant Snapping Tool:

This tool allows the user to align an implant on a bone and take measurements

defining the ‘fit’ of the component (i.e., Underhang/Overhang measurements), utilizing

constructions as defined for SAAT. This information can be analyzed in SIST, as well

as exported to Excel for post-processing.

Figure 24: Screenshot of SIST

The Stryker Orthopedics Modeling & Analytics (SOMA) is a suite of tools which utilizes a

comprehensive database of CTs, allowing the user to assess population differences in bone

morphology, bone density, and implant fit for the purposes of research and development. These

tools, in combination with the database, have been previously utilized for development of many

implant designs and techniques in hip and knee arthroplasty, as well as in trauma surgery.

Several tools are currently in development in order to be able to further analyze bone density

and enhance component fit.


CHAPTER 3

RESEARCH AIMS

The main aim of carrying out this research work is to optimize the bone cutting coverage

of the Robotics Knee Surgery. While doing the surgery, surgeon make resections on bone to

remove the affected part so that he can replace it with the prosthesis, which is Triathlon Knee

Implant in case of Mako. As part of Robotic surgery ensuring safety to the soft tissues near the

resection is always a big advantage as the robotic arm locks the motion with a specified limit

know as haptics. Haptics are 2D plane with a pre-defined boundary which helps in controlling

the motion of the arm.

As part of this Project we want to completely cover the bone to be resected and at the

same time we also want to ensure safety to the soft tissues. In this research we are utilizing the

capability of SOMA suite and the bone database. We have collected the datapoints on CT scan

segmented 3D bone models for a total of 554 bones and then a statistical analysis is performed

on the collected data which has given us an optimized shape for better bone coverage and safety

to soft tissues.

The bone data collected from SOMA suite is also divided into eight different sizes of

Triathlon and then statistical analysis is performed based on the specific size of Implant. The

data collected for Size 1 Triathlon Bone is analyzed for Triathlon Size 1 Implant resection and in

the same way analysis of other sizes is conducted.


Figure 25: Number of Bones Per Size of Triathlon Implant

The total 554 bones considered for analysis are sub divided into eight categories of

Implant sizes (Figure 25). The number of bones per size of Triathlon Implant is tested for

normality on Minitab and the result is found to be normal with a p-value of 0.165 (Figure 26).

Probability Plot of Number of Bones


Normal
99
Mean 69.25
StDev 60.10
95 N 8
AD 0.479
90
P-Value 0.165
80
70
Percent

60
50
40
30
20

10
5

1
-100 -50 0 50 100 150 200
Number of Bones

Figure 26: Anderson Darling Normality Test for Number of Bones


CHAPTER 4

MATERIALS AND METHODS

The research is based on carrying out statistical analysis on the data collected from

SOMA and then designing the boundary of resection i.e. Haptics based on the result of analysis.

In order to collect the data from SOMA it is first necessary to take measurements from the

Triathlon Implants and then replicating the constructions on SOMA. In this chapter we will focus

on the method of creating a study on SOMA and then collecting data from it. We will also

understand the statistical analysis thus conducted on the data.

The Triathlon Femoral Implant has five resections:

A. Anterior Resection

B. Anterior Chamfer Resection

C. Distal Resection

D. Posterior Chamfer Resection

E. Posterior Resection

Figure 27: Triathlon Femoral Component Views and Five Resections


The study on SOMA is also created in the same manner as we have resections on Implant

i.e. starting from Anterior Resection to Posterior Resection. While creating the study on SOMA

we replicated the same procedure as we follow in real world while aligning Implant to the bone.

In this way we were able to get the distal resection plane and posterior resection plane. Now

based on the Implant 3D CAD geometry we were able to create the other resections on SOMA

bone template with the data we collected from CAD model.

Figure 28: Distal Resection Setup on SOMA

In the Figure 28, a method to establish Distal Resection in SOMA is shown. The plane

with four green markers is depicted as Distal Resection on Femoral bone model. The resection

plane is established from Mechanical Axis Plane as the Distal Resection Plane is perpendicular

to the Mechanical Axis Plane. The Mechanical Axis is the axis passing through two points – Hip

Center Point and Knee Center Point.


Figure 29: Posterior Resection Setup on SOMA

The next step is to establish the Posterior Resection in SOMA shown in Figure 29. In this

setup a perpendicular plane to Distal Plane. This plane is at a distance from most posterior point

equal to the distance of distal plane from the most distal point in order to maintain the gap

between femur and tibia throughout the flexion and extension of knee.

Figure 30: Gap Balance between Femur and Tibia through Range of Motion
After we established the two main resections Distal and Posterior, we started establishing

the other resections i.e. Anterior, Anterior Chamfer and Posterior Chamfer for all the sizes of

Implants. In Figure 31, all five resection planes are shown on Femur bone in sagittal view.

Figure 31: Five Resection Planes on Femur in Sagittal View

Once we have created the five resection planes on femur, we took intersection of planes

with the bone to get the shape of resection on the bones. These resection shapes are very

important for the research as this information gives us the area of bone to be resected from the

original bone. The measurements taken on the resection shapes became the basis of the data

collection and further statistical analysis on the data. As we have five resection planes similarly,

we have five resection shapes. In Figure 32, the five resection shapes are shown on the femur

bone in SOMA suite.


Figure 32-A Figure 32-B

Figure 32-C Figure 32-D

Figure 32-E

Figure 32 A to E: Intersection of Resection Plane and Bone Models for


Anterior, Anterior Chamfer, Distal, Posterior Chamfer and Posterior Resection
After reaching the step of resection shapes, we have placed points on the extreme ends

of the shapes at an interval of 5mm each. The data is collected from the location of these extreme

points for all five resection shapes. The distance of these extreme points from the Mechanical

Axis Plane is measured. In Figure 33, Anterior Resection Shape is shown with Extreme Points

marked at 5mm distance from each other in Superior-Inferior direction.

Figure 33: Points Marked on Anterior Resection Shape

Similarly, the points are marked on each resection shape and the measurements are

carried for each resection shape extreme points in both medial and lateral direction. Different

resections have different number of points spacing in Superior-Inferior direction. In all the

resections the points spacing is equally spaced 5mm to each other to collect the appropriate

amount of data which can yield a meaningful result for optimization. An image of all the points in

each resection is shown in Figure 34.


Figure 34: Points Marked on all Five Resection Shapes (View 1)

Figure 35: Points Marked on all Five Resection Shapes (View 2)


Figure 36: Bar Chart of Number of Points Per Resection for Each Implant Size

The amount of data collected for each resection is massive in number. Figure 36 shows

the Bar Chart for number of points per resection for each Implant Size. Total number of points

collected for each resection and each size is shown in Table 1.

Anterior Posterior
No. of Anterior Distal Posterior
S.No. Parameter Chamfer Chamfer
Specimen Resection Resection Resection
Resection Resection
1 No. of Points per Resection → 24 14 22 12 36
2 Implant Size 1 10 240 140 220 120 360
3 Implant Size 2 35 840 490 770 420 1260
4 Implant Size 3 105 2520 1470 2310 1260 3780
5 Implant Size 4 151 3624 2114 3322 1812 5436
6 Implant Size 5 147 3528 2058 3234 1764 5292
7 Implant Size 6 81 1944 1134 1782 972 2916
8 Implant Size 7 15 360 210 330 180 540
9 Implant Size 8 10 240 140 220 120 360

Table 1: Number of Points Collected Per Size and Per Resection


The total number of points collected for all sizes and all resections are 59832 (Fifty Nine

Thousand Eight Hundred and Thirty Two). This is a very huge amount of data which is

statistically analyzed using MS Excel and Minitab.

Figure 37: Data for Anterior Resection from SOMA

Figure 38: Data for Anterior Chamfer Resection from SOMA


Figure 39: Data for Distal Resection from SOMA

Figure 40: Data for Posterior Chamfer Resection from SOMA


Figure 41: Data for Posterior Resection from SOMA

The data analyzed using MS Excel and Minitab is now evaluated and implemented in

CAD models of Haptics Boundaries. The New Haptic Boundaries are then compared with the

Existing Haptic Boundaries.


CHAPTER 5

RESULTS

In this chapter, we will focus on the implementation of the analyzed data in CAD models

and how they are making impact on the geometry of the Haptic Boundaries. The data is tested

for normality and once it is found to be normal, the normal distribution theory is applied on the

data. Considering the Normal Distribution Theory, the data lies within two standard deviation

from the mean (average) captures 95% of the normal data. The mean and standard deviation of

the data is calculated, and upper limit is calculated by adding two times standard deviation in

the mean of the data. The upper limit is then plotted in CAD software.

Figure 42: Existing Haptic for Anterior Resection


Figure 43: Existing Haptic for Anterior Chamfer Resection

Figure 44: Existing Haptic for Distal Resection


Figure 45: Existing Haptic for Posterior Chamfer Resection

Figure 46: Existing Haptic for Posterior Resection


Figure 47: Existing Haptic for Five Resections of Femur

In Figure 42 to Figure 47, five existing haptics geometries are shown. Figure 42 denotes

the Anterior resection, figure 43 denotes the Anterior Chamfer Resection, figure 44 denotes the

Distal Resection, figure 45 denotes the Posterior Chamfer Resection, figure 46 denotes the

Posterior Resection and figure 47 denotes all five resections in a single view with the Femoral

Implant in the center.

Now let us focus on the New haptics plotted in CAD system based on the data we have

received from the statistical analysis. In order to visualize the difference between the existing

haptics and new haptics both are shown overlapping each other. In the images, color Yellow

denotes the existing haptics and color Pink denotes the new haptics.
Figure 48: Existing Haptic in Yellow and New Haptic in Pink
For Anterior Resections

Figure 49: Existing Haptic in Yellow and New Haptic in Pink


For Anterior Chamfer Resections
Figure 50: Existing Haptic in Yellow and New Haptic in Pink
For Distal Resections

Figure 51: Existing Haptic in Yellow and New Haptic in Pink


For Posterior Chamfer Resections
Figure 52: Existing Haptic in Yellow and New Haptic in Pink
For Posterior Resections

The modified haptics shown in figure 48 to figure 52 in Pink Color are obtained by the

values we have received from the result of analysis. Figure 48 is an overlapping of existing haptic

and new haptic for Anterior Resection. Figure 49 is an overlapping for Anterior Chamfer

Resection. Figure 50 is an overlapping for Distal Resection. Figure 51 is an overlapping for

Posterior Chamfer Resection and Figure 52 is an overlapping for Posterior Resection.


CONCLUSIONS AND RECOMMENDATIONS

After completing the analysis and creating CAD models of New Haptics based on the

results obtained from SOMA database, now it is the time to evaluate the quantitative and

qualitative improvement of new design over the existing design. For the comparison purpose we

are considering area of haptic responsible for bone coverage as one of the prime factors of

optimization. The percentage change in area over the original area is reported as the percentage

of optimization made for that resection. The Optimization completed for the various resections

are given in Table 2.

S.No. Resection Percentage Optimization

1 Anterior Resection 17.14

2 Anterior Chamfer Resection 3.25

3 Distal Resection 15.33

4 Posterior Chamfer Resection 0.45

5 Posterior Resection 3.58

Table 2: Percentage Optimization for Each Resections

The percentage optimization is one crucial parameter, but it is the quantitative

improvement of new design over the existing design. In Anterior Resection and Distal Resection,

the amount of optimization is impressive with 17.14% and 15.33% respectively, however the
amount of optimization in Anterior Chamfer Resection and Posterior Resection is 3.25% and

3.58% respectively. The percentage optimization in Posterior Chamfer Resection is negligible

with a value of 0.45% only.

The aim of this research is not just restricted to the quantitative improvement, but it further

extends to the qualitative improvement. In some resections the amount of optimization is not

high however the change in shape of the haptic enables the better reach of the cutting blade

over the bone. In Figure 53 to Figure 57 the change in shape of haptics over bone coverage is

depicted which explains the qualitative improvement in design.

Figure 53: Change in Haptic for Anterior Resection in Pink


Figure 54: Change in Haptic for Anterior Chamfer Resection in Pink

Figure 55: Change in Haptic for Distal Resection in Pink

Figure 56: Change in Haptic for Posterior Chamfer Resection in Pink


Figure 57: Change in Haptic for Posterior Resection in Pink

The haptic optimization is done based on the data from SOMA analysis but while doing

so one more parameter was considered, i.e. the width of the saw blade which is used for making

resection. The width of the haptics at any point in space is kept at least greater than the width of

the saw blade with excursion. That is one the reason why we may not able to achieve very high

change in area for some resections but still we can ensure the good performance of cutting tool

within the haptic and the change in shape of the haptic ensures the better coverage.

As a recommendation, the optimization can be carried out on Tibial resection also which

is out of scope for this project. While doing haptic optimization only Femoral resection was

considered. The result of optimization is still a theoretical evaluation and this further can be

tested on real world cases and a comparative study of practical benefits over the theoretical

analysis can be evaluated.


APPENDIX – I

NORMAL DISTRIBUTION THEORY

The normal distribution is the most widely known and used of all distributions. Because

the normal distribution approximates many natural phenomena so well, it has developed into a

standard of reference for many probability problems.

Figure 58: Normal Distribution Curve with 68-95-99.7 rule

Characteristics of the Normal Distribution

1. Symmetric, bell shaped

2. Continuous for all values of X between -∞ and ∞ so that each conceivable interval of

real numbers has a probability other than zero.

3. -∞ ≤ X ≤ ∞
4. Two parameters, μ and σ. Note that the normal distribution is actually a family of

distributions, since μ and σ determine the shape of the distribution.

5. The rule for a normal density function is

1 2 /2𝜎 2
𝑓(𝑥; 𝜇, 𝜎 2 ) = 𝑒 −(𝑥−𝜇)
√2𝜋𝜎 2

6. The notation N(μ, σ2) means normally distributed with mean μ and variance σ 2. If we

say X ∼ N(μ, σ2) we mean that X is distributed N(μ, σ2).

7. About 2/3 of all cases fall within one standard deviation of the mean, that is

P(μ - σ ≤ X ≤ μ + σ) = 0.6826

8. About 95% of cases lie within 2 standard deviations of the mean, that is

P(μ - 2σ ≤ X ≤ μ + 2σ) = 0.9544

9. About 99.7% of cases lie within 3 standard deviations of the mean, that is

P(μ - 3σ ≤ X ≤ μ + 3σ) = 0.9974


APPENDIX – II

BASIC THREE-DIMENSIONAL TRANSFORMATIONS

There are three basic 3-D Transformations which are often used, these are scaling, translation
and rotation. In this appendix we will focus on all three basic transformations.

1. SCALING

In x-direction Scaling is defined as Sx

In y-direction Scaling is defined as Sy

In z-direction Scaling is defined as Sz

Figure 59: Scaling Transformation


2. TRANSLATION

In x-direction Translation is defined as Tx

In y-direction Translation is defined as Ty

In z-direction Translation is defined as Tz

Figure 60: Translation Transformation


3. ROTATION

In x-direction Rotation is defined as Rx

In y-direction Rotation is defined as Ry

In z-direction Rotation is defined as Rz

4.

Figure 61: Rotation Transformation


REFERENCES

1. Mako Partial Knee Arthroplasty: clinical summary, volume 5, stryker

2. Mako Total Knee Arthroplasty: clinical summary, volume 5, stryker

3. Mako Total Hip Arthroplasty: clinical summary, volume 5, stryker

4. Alisdair Gilmour, Angus D. MacLean, Philip J. Rowe, Matthew S. Banger, Iona Donnelly,

Bryn G. Jones, Mark J.G. Blyth: Robotic-arm assisted vs conventional unicompartmental

knee arthroplasty: the 2-year clinical outcomes of a randomized controlled trial

5. B.Kayani, S. Konan, J. Tahmassebi, J. R. T. Pietrzak, F. S. Haddad: Robotic-arm assisted

total knee arthroplasty is associated with improved early functional recovery and reduced

time to hospital discharge compared with conventional jig-based total knee arthroplasty

6. Fazel Khan, Andrew Pearle, Christopher Lightcap, Patrick J. Boland, John H. Healey:

Haptic Robot-assisted Surgery Improves Accuracy of Wide Resection of Bone Tumors:

A Pilot Study

7. E. Hampp; M. Bhowmik-Stoker; L. Scholl; J. Otto; D. Jacofsky; M. Mont: Robotic-arm

assisted total knee arthroplasty demonstrated soft tissue protection

8. Jeffrey J. Cherian, Bhaveen H, Kapadia, Samik Banerjee, Julio J. Jauregui, Kimona Issa,

Michael A. Mont: Mechanical, Anatomical, and Kinematic Axis in TKA: Concepts and

Practical Applications

9. Kashitaro Hyodoa, Tadashi Masudac, Junya Aizawad, Tetsuya Jinnoe, Sadao Moritaf:

Hip, knee, and ankle kinematics during activities of daily living: a cross-sectional study

10. A. P. Monk, K. Choji, J. J. O’Connor, J. W. Goodfellow, D. W. Murray: The shape of the

distal femur A GEOMETRICAL STUDY USING MRI


11. Javad Hashemi, Naveen Chandrashekar, Brian Gill, Bruce D. Beynnon, James R.

Slauterbeck, Robert C. Schutt Jr., HosseinMansouri, Eugene Dabezies: The Geometry

of the Tibial Plateau and Its Influence on the Biomechanics of the Tibiofemoral Joint

12. Michelle J Lespasio, Nicolas S Piuzzi, M Elaine Husni, George F Muschler, AJ Guarino,

Michael A Mont: Knee Osteoarthritis: A Primer

13. Jean-Pierre Raynauld, Johanne Martel-Pelletier, Marc Dorais, Boulos Haraoui, Denis

Choquette, François Abram, André Beaulieu, Louis Bessette, Frédéric Morin, Lukas M.

Wildi, Jean-Pierre Pelletier: Total Knee Replacement as a Knee Osteoarthritis Outcome:

Predictors Derived from a 4-Year Long-Term Observation following a Randomized

Clinical Trial Using Chondroitin Sulfate

14. Zhenyu Luo, Zeyu Luo, Haoyang Wang, Qiang Xiao, Fuxing Pei, Zongke Zhou: Long-

term results of total knee arthroplasty with single-radius versus multi-radius posterior-

stabilized prostheses

15. Walter Schmidt, Sally LiArno, Anton Khlopas, Andreas Petersik, Michael A. Mont: Stryker

Orthopaedic Modeling and Analytics (SOMA): A Review

16. Mako Robotic Arm System Executive Summary, stryker

17. Christina L. Cool, Keith A. Needham, Anton Khlopas, Michael A. Mont: Revision Analysis

of Robotic Arm-Assisted and Manual Unicompartmental Knee Arthroplasty

18. Babar Kayani, Sujith Konan, Jurek R.T. Pietrzak, Fares S. Haddad: Mako Total Knee

clinical evidence, Iatrogenic Bone and Soft Tissue Trauma in Robotic-Arm Assisted Total

Knee Arthroplasty Compared with Conventional Jig-Based Total Knee Arthroplasty: A

Prospective Cohort Study and Validation of a New Classification System


19. B. Kayani, F.S. Haddad: Robotic Total Knee Arthroplasty, Clinical Outcomes and

Directions for Future Research

20. Emily L. Hampp, Laura Y. Scholl, Ta-Cheng Chang, Abdullah Abbasi, Manoshi Bhowmik,

Jason K. Otto, David J. Jacofsky, Michael A. Mont: Robotic-Arm Assisted Total Knee

Arthroplasty Demonstrated Greater Accuracy to Plan Compared to Manual Technique

21. Sue Gordon: The Normal Distribution, Mathematics Learning Centre, University of

Sydney NSW 2006

22. Saul Stahl: The Evolution of the Normal Distribution, Department of Mathematics,

University of Kansas, Lawrence

23. Anupam Saxena, Birendra Sahay: Computer Aided Engineering Design, Springer

24. David F. Rogers, J. Alad Adams: Mathematical Elements for Computer Graphics,

McGraw-Hill Book Company

25. Kalyanmoy Deb: Optimization for Engineering Design, Algorithms and Examples, PHI

Learning Private Limited


GLOSSARY

A
➢ Arthroplasty – the surgical reconstruction or replacement of a joint.

C
➢ Cartilage – firm, flexible connective tissue found in various forms in the larynx and

respiratory tract, in structures such as the external ear, and in the articulating surfaces of

joints. It is more widespread in the infant skeleton, being replaced by bone during growth.

➢ Condyles – a rounded protuberance at the end of some bones, forming an articulation

with another bone.

F
➢ Femur – the bone of the thigh or upper hindlimb, articulating at the hip and the knee.

➢ Fibula – the outer and usually smaller of the two bones between the knee and the ankle

(or the equivalent joints in other terrestrial vertebrates), parallel with the tibia.

H
➢ Hamstring – The hamstrings are a group of muscles and their tendons at the rear of the

upper leg.

➢ Haptics – the use of technology that stimulates the senses of touch and motion,

especially to reproduce in remote operation or computer simulation the sensations that

would be felt by a user interacting directly with physical objects.


➢ Hounsfield Unites – The Hounsfield unit (HU) is a relative quantitative measurement of

radio density used by radiologists in the interpretation of computed tomography (CT)

images. The absorption/attenuation coefficient of radiation within a tissue is used during

CT reconstruction to produce a grayscale image.

L
➢ Ligament – a short band of tough, flexible fibrous connective tissue which connects two

bones or cartilages or holds together a joint.

M
➢ Meniscus – a thin fibrous cartilage between the surfaces of some joints, e.g. the knee.

➢ Morphology – the study of the forms of things.

O
➢ Osteoarthritis – It occurs when the protective cartilage that cushions the ends of your

bones wears down over time.

P
➢ Patella – The patella, also known as the kneecap, is a flat, circular-triangular bone which

articulates with the femur (thigh bone) and covers and protects the anterior articular

surface of the knee joint.

➢ Plateau – an area of fairly level high ground.

➢ Prosthesis – an artificial body part, such as a limb.


Q
➢ Quadriceps – the large muscle at the front of the thigh, which is divided into four distinct

portions and acts to extend the leg.

S
➢ Synovial – a type of joint which is surrounded by a thick flexible membrane forming a sac

into which is secreted a viscous fluid that lubricates the joint.

T
➢ Tendon – a flexible but inelastic cord of strong fibrous collagen tissue attaching a muscle

to a bone.

➢ Tibia – the inner and typically larger of the two bones between the knee and the ankle

(or the equivalent joints in other terrestrial vertebrates), parallel with the fibula.

➢ Triathlon – The Triathlon Total Knee System is a primary total knee replacement system

designed to work with the body.


Saxena, Rachit

From: Arora, Aman


Sent: Monday, April 06, 2020 10:21 AM
To: Saxena, Rachit; Rehan, MD
Subject: RE: M.Tech End Sem Report for Review

Looks good to me buddy, please proceed.

Thanks & Regards,


Aman

From: Saxena, Rachit <rachit.saxena@stryker.com>


Sent: Monday, April 06, 2020 10:14 AM
To: Rehan, MD <Md.rehan@stryker.com>; Arora, Aman <Aman.Arora@stryker.com>
Subject: RE: M.Tech End Sem Report for Review

Hi Rehan,

Thank you for giving it a review.


I will accept the highlighted changes.

@Arora, Aman: Please let me know if I can proceed with this report?

Regards,
Rachit

From: Rehan, MD <Md.rehan@stryker.com>


Sent: Sunday, April 05, 2020 8:24 PM
To: Saxena, Rachit <rachit.saxena@stryker.com>; Arora, Aman <Aman.Arora@stryker.com>
Subject: RE: M.Tech End Sem Report for Review

Rachit – I made minor edits here and there (tracked). Overall looks good to me. Thanks.

From: Saxena, Rachit <rachit.saxena@stryker.com>


Sent: Friday, April 3, 2020 12:12 AM
To: Rehan, MD <Md.rehan@stryker.com>; Arora, Aman <Aman.Arora@stryker.com>
Subject: M.Tech End Sem Report for Review

Hi Rehan and Aman,

I have completed my M.tech End Sem Report file.


I have attached a PDF copy of the same with this mail.
Request you to please review the file and let me know if it is ok to go ahead and submit it.
I am suppose to submit this report by April 07, 2020.
Best Regards,
Rachit Saxena
Senior Engineer
Stryker Global Technology Center
Vatika Business Park, 11th Floor, Block-Two,
Sector 49, Sohna Road, Gurgaon -122001,
Haryana, India
Mob: +91-9711411731
Phone: +91-124-3850357

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