INITIAL SPECIFICATION FOR A

MODULAR HIP IMPLANT

Biomechanics – Assignment 2
Professor – Patrick Wulliamoz

Lucas Washington S. R. Santana

D20123757

07/05/2021
Table of Contents
Abstract ............................................................................................................................ 2

1. INTRODUCTION.......................................................................................................... 2

2. INSTALLATION METHOD ............................................................................................ 2

3. PERFORMANCE CHARACTERISTICS ............................................................................. 4

4. MATERIAL .................................................................................................................. 4

5. PHYSICAL SIZE ............................................................................................................ 5

6. MECHANICAL REQUIREMENTS ................................................................................... 6

7. STERILIZATION ........................................................................................................... 6

8. DESIGN INPUTS .......................................................................................................... 7

9. DESIGN OUTPUTS....................................................................................................... 8

10. TESTING PROTOCOLS.............................................................................................. 8

11. DISCUSSION AND CONCLUSION .............................................................................. 8

REFERENCES .................................................................................................................... 10

Lucas Washington Santa Rita Santana – D20123757 1

Abstract

The aim of this paper is to provide the initial specifications for a modular hip
implant using Titanium alloy (Ti-6AL-V4), which is a biocompatible material that has
been used previously in hip implants. Additionally, a hydroxyapatite coating will be
used in order to stimulate bone integration into the implant.

1. INTRODUCTION

Hip implants are medical devices that help people with arthritis and other hip
disorders or injuries to regain mobility and alleviate pain. There are different hip
implant systems and they have their own benefits and risks as well as their own set of
design characteristics, including size, shape, material, and dimensions. Furthermore,
different patients can have different outcomes from the same hip implant system. The
product design features, surgeon experience and implantation procedure, as well as
individual patient characteristics such as age, sex, weight, activity level, and overall
health, can all affect the outcome and durability of a hip implant. [7]

Figure 1 - Comparison between a healthy, arthritic and implanted hip. Source: Hospital for Special Surgery.

2. INSTALLATION METHOD

For a total replacement of the hip, the steps for the procedure may vary
depending on the surgeon’s training and method used. Additionally, it will also depend
on the patient’s physiology and health condition. Generally, the steps are as follows
(with steps 7,8 and 9 being the most important: [5,7]
1. The levels of blood pressure, heart rate, body temperature, and oxygenation of

the patient are measured and compared with normal limits before surgery
begins.

Lucas Washington Santa Rita Santana – D20123757 2

 2. Anaesthesia is provided to the patient. A patient can be put to sleep with general

anaesthesia or given local anaesthesia with a relaxant to block sensation from

the waist down.
3. An incision is made, to expose the bones at the hip joint.

4. The surgeon removes the femur head from its socket (acetabulum) in the pelvis.

5. A bone saw is used to remove the arthritic femoral neck. The osteotomy is done

cutting at an angle of ninety degrees with centre of femoral head.

6. A pilot hole is made using a stepped IM initiator and aligned with the femoral

canal.
7. A reamer is used to cut through the femur bone until cortical contact is reached.

The stem’s top is made to accommodate a prosthetic ball that will replace the
femoral head.
8. The proximal canal can be prepared with a series of triple-banded reamers. As

the proximal diameter grows, the position of each colour band shifts from distal
to proximal. The surgeon is required to ream until cortical contact is achieved.
9. Depending on the final proximal reamer used, an appropriate miller shell size

is used. The miller shell's distal end is attached to the required color-coded
pilot shaft. Finally, the femur is prepared with the required size of triangle
mil/drill to match the calcar spout of the final sleeve.
Note: Cone reamers and miller shells provide numerical markings of the
proximal diameter for cross reference verification.

Figure 2 - Steps 7 (distal ream), 8 (proximal ream), 9 (calcar ream/mill) and final implantation. Source: S-ROM
modular hip system.

10. The top of the femoral stem is fitted with a temporary prosthetic ball. The new

acetabulum cup is size-matched to this ball. The surgeon places it in the new

Lucas Washington Santa Rita Santana – D20123757 3

 socket and move the hip around to ensure that the joint is comfortable and does
not dislocate.
11. The sleeve introducer is used to position the sleeve implant. For version control,

position the stern introducer on the femoral implant and implant using the pin
punch. When the stem can no longer advance, the taper is closed.
12. To ensure that the size and position of the components are correct, x-rays are

taken.

3. PERFORMANCE CHARACTERISTICS

The initial stability of the femoral portion and the stress shielding effect are both
important factors in the success of a total hip arthroplasty. In fact, initial stability is of
paramount importance for bone ingrowth into the stem coating in cementless stems.
Thigh discomfort can also be caused by a lack of primary flexibility. Furthermore, bone
adaptation following surgery can result in unnecessary bone loss, which can
jeopardize the implant's effectiveness. These variables are influenced by the
prosthesis' nature, specifically the material, interface conditions, and form. [14]
For cementless modular hip implant, the loss in performance and failure of
prosthesis is mainly due to the combination of three causes: the relative tangential
displacements, normal contact stress and stress shielding effect [14]. Therefore, to
meet basic requirements the implant should have at least good stability, acceptable
wear rate, low friction forces, good fixation, adequate strength and appropriate
articulation [17].

4. MATERIAL

The titanium alloy Ti-6AL-V4 is a bioinert material widely used in

cementless total hip arthroplasty [12] and have found applications in a variety of fields,
including the automotive, aerospace, and petrochemical industries, as well as offshore
equipment and medical implants such as knee and hip [9]. Due to its microstructure,
has a higher fatigue resistance than pure titanium. Because of their excellent
properties, such as high strength-to-weight ratio, high corrosion resistance, and bio
compatibility, Ti6Al4V is one of the most widely used titanium alloys [10].

Lucas Washington Santa Rita Santana – D20123757 4

 Because of its high osteoconductivity, Hydroxyapatite, the main inorganic
component of mammalian bone or tooth, has attracted attention as a surface-coating
compound and thus it is widely utilised with titanium alloys in medical implants [13].

Figure 3 - Material properties and composition (Ti6Al4V). Source: [8].

5. PHYSICAL SIZE
The size of a modular hip implant can vary due to age, gender, height, weight, bone
structure etc. of the patient. The following geometry parameters are taken from a 90kg
patient [20]:
• Head diameter: 56 mm
• Neck diameter: 26.8 mm (base) and 11.93 mm (top)
• Neck angle: 50º
• Length of stem: 169.51 mm

Figure 4 - Geometry of modular hip implant

Lucas Washington Santa Rita Santana – D20123757 5

 6. MECHANICAL REQUIREMENTS

The article developed by Fiorentino et al. [18] shows different magnitudes of

contact forces on hip implants for different activities using finite element method. The
results illustrated in figure below, show that the maximum load is around 11,000 kN
for stumbling. These figures are of paramount importance when establishing the
material used for the implant as it needs to match requirements in terms of resistance
and fatigue.

Figure 5 - Contact forces on hip joint during regular activities. Source: [18]

Figure 6 - Fatigue test. 1) Sample 2) Load 3) Loading device 4) Example of sample container 5) Fixing media 6)
Metal plate 7) Metallic head. Note: CT and D are respectively the total and free lengths of the stem. Source: [18].

7. STERILIZATION

There are various methods used in biomedical sector to sterilise medical

equipment. The two most used are: Ethylene Oxide (50% of all medical equipment in
the U.S) and Gamma radiation [15]. For certain medical devices, ethylene oxide
sterilization may be the only approach that efficiently sterilizes while causing no harm
to the device during the process. The FDA created a pilot program known as the
master file that aims to ensure patient access to safe medical devices while promoting

Lucas Washington Santa Rita Santana – D20123757 6

new, creative ways to sterilize medical devices that reduce the gas's possible effect
on the environment and public health as some studies have found that there is a risk
of cancer when concentration of the substance on medical devices is above the limit
established by FDA [15,16].
Therefore, for this initial specification, ethylene oxide will be utilised to sterilise
the device.

8. DESIGN INPUTS

For initial specification of this modular implant, the aim of this report is to
develop four significant design inputs and they are described as follows:
1. The acetabular inclination (E-D) should ideally range between 30-50°. This
input is very important because there is a risk of dislocation if the angle is larger
than the upper limit.
2. Leg length discrepancy should be less than 1 cm. Leg length discrepancy is
difference between the vertical distances A and B. After the surgery, the
inequality between the leg lengths is common but a tolerance is established to
ensure better performance of the implant and less discomfort to the patient.
3. Horizontal centre of rotation should be equal to that of contralateral hip. The
distance between the femoral head's centre (C) and the teardrop shadow (D)
defines the horizontal centre of rotation. This distance should ideally be equal
to the distance between the contralateral hip and the acetabular component;
excessive lateral placement of the acetabular component raises the risk of
dislocation and can result in limping.
4. Femoral stem should have neutral alignment with the longitudinal axis of the
femoral shaft.

Figure 7 - Design inputs 1, 2, 3 and 4. Source: [21]

Lucas Washington Santa Rita Santana – D20123757 7

 9. DESIGN OUTPUTS
To assure that the four design inputs are correct and within limits, the surgeon
can use a robotic assistance to enhance accuracy on the replacement of the hip. A
pre-surgery digital template model of the hip using a computer program along with x-
rays can be used to evaluate that the components are properly sized and positioned.

10.TESTING PROTOCOLS

According to FDA, hip implants are considered to be of class III as it is high-risk

device. The tests required for hip implants are carried out in compliance with the ISO-
7206 specification and part of them are described as follows [16]:
• Fatigue testing on femoral neck, hip stem and acetabular cup to validate hip
implant in terms of durability and performance in a long-term utilisation;
• Wear testing;
• Immunological reaction to device and others.
Some suggestions on testing this device includes:
o Concentration of Ethylene Oxide (method of sterilisation used in this
report) on the implant to ensure that the device does not offer any
harm to patient.
o Assessment of the articulation of the joint: the degrees of freedom
should be appropriate.
o Failure analysis.
The chance of developing a particular complication with hip replacement is up
to 3% for a healthy person. In order to achieve a successful surgery, the proper
installation procedure must be followed in accordance with specifications. Dislocation,
infection, blood clots, and lack of adherence between the bone and implant are some
of the main complications found in unsuccessful procedures according to National
Institute of Arthritis and Musculoskeletal and Skin Disease [22].

11.DISCUSSION AND CONCLUSION

Hip arthropathy is one of the most effective surgical intervention and it has
helped many patients with hip disorders to regain their life quality. The aim of this
report is to provide the initial specifications along with four design inputs for a
cementless modular hip implant using Ti-64Al-V4 and a hydroxyapatite coating.

Lucas Washington Santa Rita Santana – D20123757 8

 Relief of pain, adequate function and durability are some of the essential
requirements for total hip arthroplasty. In respect to design criteria, good stability, low
friction forces, appropriate articulation and adequate selection of material are some of
the basic requirements to develop such device with high performance.
The results show that the three main factors of loss in performance are related
to relative tangential displacements, normal contact stress and stress shielding effect.
Moreover, the highest contact force amongst all activities occurs when stumbling
(11,000 kN).
The project of a prosthetic joint should be a collaborative endeavour involving
both a surgeon and an engineer. In the end, even with good joint designs, the clinical
outcomes would be determined by the surgeon's capacity.

Lucas Washington Santa Rita Santana – D20123757 9

REFERENCES

[1] Health Products Regulatory Authority. (2009). Guide to Classification of a Medical

Device, Health Products Regulatory Authority. 1(1), pp. 3–11. Available at:
https://www.hpra.ie/docs/default-source/publications-forms/guidance-
documents/adv-g0004-guide-to-classification-of-a-medical-device-v2.pdf?sfvrsn=10.
[2] Milovanović, A. et al. (2020). Design Aspects of Hip Implant Made of Ti-6Al-4V
Extra Low Interstitials Alloy. Procedia Structural Integrity, 26(2019), pp. 299–305. doi:
10.1016/j.prostr.2020.06.038.
[3] Food and Drug Administration Centre for Devices and Radiological Health. (1997).
Design control guidance for medical device manufacturers. Design History File, p. 53.
[4] Orthopaedic-testing-hip-implants. (2020). Available at: https://devicetesting.com/
orthopaedic-testing-hip-implants.cfm. [accessed 5 May 2021].
[5] DePuySynthes. (2013). S-ROM® modular Hip System, S-ROM® Surgical
Technique - DePuy Synthes®, Warsaw, IN. Available at:
https://www.jnjmedicaldevices.com/en-US/companies/depuy-synthes.
[6] U.S Food and Drug Administration. (2019). General Information about Hip Implants.
Available at: https://www.fda.gov/medical-devices/metal-metal-hip-implants/general-
information-about-hip-implants. [accessed 05 May 2021].
[7] Arthritis-Health. (2020). Total Hip Replacement Surgical Procedure. Available at:
https://www.arthritis-health.com/surgery/hip-surgery/total-hip-replacement-surgical-
procedure. [accessed 5 May 2021].
[8] Peppas, N. A. (2000). Handbook of Biomaterial Properties. Journal of Controlled
Release, 65(3), p. 439. doi: 10.1016/s0168-3659(99)00208-4.
[9] Zhong, C. et al. (2020). ‘Laser metal deposition of Ti6Al4V-A brief review’, Applied
Sciences (Switzerland), 10(3), pp. 1–12. doi: 10.3390/app10030764.
[10] Marc Long, H.J. Rack. (1996). Titanium alloys in total joint replacement—a
materials science perspective. School of Chemical and Materials Engineering,
Clemson University. Available at: https://www.sciencedirect.com/science/article/pii/
S0142961297001464.
[11] Aitchison, G. et al. (2009). ‘A Review of the Design Process for Implantable
Orthopedic Medical Devices’, The Open Biomedical Engineering Journal, 3(1), pp. 21–
27. doi: 10.2174/1874120700903010021.

Lucas Washington Santa Rita Santana – D20123757 10

[12] Schuh, A. et al. (2007). ‘Second generation (low modulus) titanium alloys in total
hip arthroplasty’, Materialwissenschaft und Werkstofftechnik, 38(12), pp. 1003–1007.
doi: 10.1002/mawe.200700230.
[13] Kuroda, K. and Okido, M. (2012) ‘Hydroxyapatite Coating of Titanium Implants
Using Hydroprocessing and Evaluation of Their Osteoconductivity’, Bioinorganic
Chemistry and Applications, 2012. doi: 10.1155/2012/730693.
[14] Ruben, R. B., Fernandes, P. R. and Folgado, J. (2012) ‘On the optimal shape of
hip implants’, Journal of Biomechanics, 45(2), pp. 239–246. doi:
10.1016/j.jbiomech.2011.10.038.
[15] Goodman, B. and Miller, A. (2019). Cancer Risks Spur Calls to Replace Ethylene
Oxide. Available at: https://www.webmd.com/special-reports/ethylene-oxide/201
90925/cancer-risks-spur-calls-to-replace-ethylene-oxide [accessed on 05 May 2021].
[16] FDA. (2019). Ethylene Oxide Sterilization for Medical Devices. Available at:
https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/
ethylene-oxide-sterilization-medical-devices
[17] Elloy, M. A., Wright, J. T. M. and Cavendish, M. E. (1976) ‘the Basic Requirements
and Design Criteria for Total Joint Prostheses’, Acta Orthopaedica, 47(2), pp. 193–
202. doi: 10.3109/17453677608989718.
[18] Fiorentino, A. et al. (2013) ‘Hip prosthesis design. Market analysis, new
perspectives and an innovative solution’, Procedia CIRP, 5(December), pp. 310–314.
doi: 10.1016/j.procir.2013.01.061.
[19] Latham, B. and Goswami, T. (2004) ‘Effect of geometric parameters in the design
of hip implants paper IV’, Materials and Design, 25(8), pp. 715–722. doi:
10.1016/j.matdes.2004.01.012.
[20] Shaik, S. A., Bose, K. and Cherukuri, H. P. (2012) ‘A study of durability of hip
implants’, Materials and Design, 42, pp. 230–237. doi: 10.1016/j.matdes.2012.05.049.
[21] Vanrusselt, J. et al. (2015) ‘Postoperative radiograph of the hip arthroplasty: what
the radiologist should know’, Insights into Imaging, 6(6), pp. 591–600. doi:
10.1007/s13244-015-0438-5.
[22] Drug Watch. (2020). Hip replacement. Available at:
https://www.drugwatch.com/hip-replacement/. [accessed on 5 May 2021.

Lucas Washington Santa Rita Santana – D20123757 11