Total Knee

Replacement
Michael Tramontozzi, Chelsea
Benzie, Hallie Charapp,
Charles Baker, Michael
Chacko

Problem: Tibial Components in TKRs are

Prone to Aseptic Loosening with Extended
Use

Components of a Total Knee Replacement

(TKR) and Our Focus for This Lecture

1) Femoral Cap
2) Tibial Stem
Insert *
5

3) Tibial
4) Femur
5) Articular
Surface

The Use of Biodegradable Cement and BMP

infused Microspheres for Fixation of the
Tibial Component in TKRs

What we Will Cover in This Lecture

Design Specifications Design Description &

Analysis

Biocompatibility

FMEA

FDA Testing Plan

Development of Our Design Specifications

Osteointegration

Structural Design

BMP infused
Microspheres

Biodegradable Cement

Decreased Aseptic
Loosening

Sustained Release Drug Delivery

Technology Benefits
Minimize systemic toxicity
Maximize the area under the curve to increase efficacy
Reduce the amount of injections
Eliminate the troughs in-between dosings

Images Taken From: http://

www.sunpharma.in/wrap-matrix.h
tm
http://weillcornellbrainandspine.or
g/condition/spinal-tumors

Chitosan Microspheres for

Sustained Delivery of BMP-2

~5 mg
60 Day release
Spray Drying
Microsphere Diameter between 200-300m Chitosan
Controllable crosslinking
Biocompatible (natural
polymer)
Inexpensive
Cation forming
polyelectrolyte complexes
Well-studied

http://www.ece.illinois.edu/mediacenter/article.asp?id=346
http://www.pharmainfo.net/reviews/spray-drying-review

Spray Drying
Supported by most large
pharma companies
Inexpensive and good

Biodegradable Cement
Polypropylene Fumarate (PPF) porous, unsaturated linear polyester
Increased compressive properties with 65% concentration gypsum
(sulfate mineral)
Cross-linking capabilities with N-vinylpyrrolidone (NVP) and methyl
methacrylate (MMA)
Biodegradability
o 50-60% weight loss after 60 days
PPF vs. PMMA
o Elasticity Modulus => 395 MPa vs. 2.28 GPa
o Yield Strength => 10.7MPa vs. 85 Mpa
In-vitro Success
Drill bit design to compensate for decreased properties

Application of PPF

Debate over optimal application in TKR surgery

Full Cementation vs. Surface Cementation

o Full Cementation
Typically Press-Fit
Studies suggest better fixation
Unnecessary cement in proximal tibia => problems

o Surface Cementation- only plateau

Less Fixation
Better Loading => Underlying bone density and
architecture are maintained.

3-4 mm of PPF
Surface Cementation allows for adequate fixation
while allowing BMP to release and bone formation
to occur.

Design Specifications (Example Table)

Research
Findings
- Aseptic
loosing is
known to
occur in both
cemented
and press fit
orthopedics

Design Specification / Inputs

Form

-Design should look similar to other effective tibial

components on the market.
-Design will utilize a porous titanium surface to
promote bone ingrowth.
-Stem of the prosthetic will be shaped like a drill bit in
an effort to prevent loosening within the tibia.

Function

-Purpose of the prosthetic is to provide superior

structural integrity for the users.
-Designed to integrate with the tibial bone and
promote bone growth within the pores of the prosthetic

User

-Designed for patients requiring a Total Knee

Replacement procedure.
-Must accommodate surgeons who will be responsible
for installing the system.
-varying anatomy sizes (male, female, adolescent)

Costs

-based on the 2008 data we could expect out product

to sell between $7000 and $8000.

Biocompati
bility

-Biocompatible materials will prevent rejection and

infection after the implant surgery.
-Stem will use Titanium metal (good biocompatibility)

Using the Design Specifications we

Designed a Model Using CAD Software

Description of Our Device Design (1 of 2)

Custom
Nesting/locking
Area for Articular
Surface
Additional Fluting
for Prosthetic
Stability

Porous Surface for

Osteointegration and
BMP Microsphere Distributio

Fluted Drill Bit

Stem Design for a Tight Fi

Description of Our Device Design (2 of 2)

Surface Reserved
for Biodegradable
Cement
Application
Ribbing to Prevent
Stem Fracture

Porous Surface Reserved for

BMP Microspheres. No
Cement in this Region.

Pointed Tip For Drill

Propagation and Biodegradab
Cement Application

Analysis of Our Design

Titanium Baseplate
Modulus
of
Elasticity
(E)

110 GPa

Poissons 0.3
Coefficien
1)
F s = 1/2 m v2
t (v)

Impact Forces on
the Prosthetic

2) Moment = F*d
Moments Acting
Across the Joint

Finite Element Analysis

BIAL PERIPROSTHETIC FRACTURE COMBINED WITH TIBIAL STEM

RESS FRACTURE FROM TOTAL KNEE ARTHROPLASTY ]

3) =*G
G=E/(2*(1+v))
Shear Forces

Failure Mode and Effects Analysis (FMEA)

Biocompatibility
Concerns

Host response

Hypersensitivity, toxicity

Infection
Open wound can cause an infection
Exposed bone: 2.5% to 15% risk of infection

Thrombosis
May occur from an inflammatory response

Activation of immunologic pathway

Foreign material will cause an immune
response
Measure amount of platelet adhesion

In-Vitro Testing
Oxford Rig Cadaver Test
Supine Range-of-Motion Test
Benchtop Test of Constraint

Run ELISA assay and build a re

profile over 60 days

In-Vivo Testing
Clinical trials using goats and lambs
(60 days)

FDA Classification
Class III
Drug delivery
New bio-degradable polymer
Screw implant mechanism
instead of press-fit

Works Cited
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC337
4549/
http://impascience.eu/bioencapsulation/340_contr
ibution_texts/2006-10-05_O4-2.pdf
http://www.sciencedirect.com/science/article/pi
i/S1742706110005805
http://www.google.com/patents/US6486232
http://www.ncbi.nlm.nih.gov/pubmed/22707817
http://www.ncbi.nlm.nih.gov/pubmed/8938235
http://
www.boneandjoint.org.uk/highwire/filestream/64454
/field_highwire_article_pdf/0/295.full-text.pdf
http://www.ncbi.nlm.nih.gov/pubmed/19280644