Overview of this lecture

MEC8017 - Bioengineering
Why do we test artificial joints?
How do we test artificial joints?
Testing of Artificial Testing artificial hip joints

Joints Testing other artificial joints

Dr Tom Joyce
26th October 2009

Why do we test artificial joints? Test methods

Because it is ethical to do so
To verify or validate:
¾ New designs
¾ Geometrical, material or manufacturing
changes to existing products
To benefit:
¾ Ultimately the patient
¾ Also the manufacturer, clinicians, fellow
scientists and regulatory bodies
European, British, International and
American standards
Other published test methods
In-
In-house test methods
Wear is the main cause of failure of most
artificial joints
Difficulty of modelling the wear process,
therefore testing is undertaken

Implant testing How do we know if a test is

successful?
Implants shall:
Validate by comparing with explants
‘be evaluated to demonstrate that the
intended performance is achieved’
achieved’ Explants may be of two types: those
retrieved at revision operation (failures)
‘undergo pre-
pre-clinical evaluation by …
and those retrieved while functioning
analysis of data obtained from testing …
correctly (i.e. at post mortem)
(which) shall simulate conditions of use’
use’
Test methods must produce same type of
BS EN ISO 14630: 1998 ‘General
‘failures’
failures’ as those seen in the body, or the
requirements for non-
non-active surgical
same ‘features’
features’ of explanted joints
implants’
implants’
 How might we test an artificial
hip joint?
What loads might we apply?
Testing artificial Should these be dynamic or constant?
hip joints Justify your answer
What motion should be applied?
Why?
How might such loading and motion be
applied?
How long should we test for?
What is an appropriate lubricant to use?

Test in a dedicated hip simulator The Paul load cycle for the hip
What load(s) to apply?
How to apply these loads?
What motion(s) to apply?
Flexion-
Flexion-extension, abduction-
abduction-adduction, rotn.
How to apply these motions?
Mimic gait or running, jumping, sleeping?
Design factors: lubricant temperature,
machine control, number of stations, range
of sizes of test implants, articulation only
General factors: test duration, lubricant

Design factors
Test duration: how long is sufficient?
Machine control
Number of stations: single-
single-station to 12-
12-
station
Size of test implants: traditionally 22mm
diameter Charnley, 28mm, 32mm, 36mm
Recent advances: 54mm metal resurfacing
 Lubricant used during testing MTS hip simulator
Distilled water, saline solution, dilute bovine
serum Twelve station
Heat the lubricant to 37°
37°C? Biaxial rocking
motion ± 23°
Dilute bovine serum offers similar wear rates,
similar wear debris and no transfer film Test
components
Current concerns with dilute bovine serum:
not in the
¾ 37°
37°C too high due to local heating anatomical
¾ Lubricant volume position
¾ Protein content (serum dilution)

Prosim hip simulator EndoLab® hip test parameters

Force curve: double-
double-peak (Paul load cycle)
Ten-
Ten-station hip Maximum load: 3kN
simulator
Five-
Frequency: 1Hz
Five-station also
available Flexion-
Flexion-extension: +25°
+25°/-18°
18°
Pneumatic actuation Abduction-
Abduction-adduction: +7°
+7°/-4°
Note that the whole Rotation: +2°
+2°/-11°
11°
joint is not tested,
only the ball and Lubricant: bovine serum at 37°
37°C
socket Test duration: 5 million cycles, components
examined every 500,000 cycles

Suppliers of hip simulators Important standards for THR

AMTI Boston http://www.amti.biz/default.htm
Shore Western
http://www.shorewestern.com/index.html
MTS
http://www.mts.com/menusystem.asp?DataS
ource=0&NodeID=373
Prosim http://www.simsol.co.uk/hip.shtml
Prosim hip simulator costs £160,000
ISO14242-
ISO14242-1 (2000). Implants for surgery -
wear of total hip joint prostheses, part 1.
Loading and displacement parameters for
wear-
wear-testing machines and corresponding
environmental conditions for test.
ISO14242-
ISO14242-2 (2000). Implants for surgery -
wear of total hip joint prostheses, part 2.
Methods of measurement.
How might we compare a laboratory
tested THR with an explanted THR?
Wear volumes, or other measure of wear
including wear debris Testing other implants
(Note that wear in vivo may be measured by
X-ray therefore mm/year, in vitro by weight
change i.e. mg/million cycles. But how do
Knee prostheses
these measurements relate?)
Morphology of the wear debris Spinal implants
Surface topography of the acetabular cup Friction testing
and the femoral head

Prosim knee MTS knee wear simulator

wear simulator
Pneumatic actuation
Six-
Six-station
To ISO14243-
ISO14243-1,
‘Implants for surgery -
wear of total knee-
knee-joint
prostheses’
prostheses’

AMTI knee simulator EndoLab® knee simulator

6 station test rig, computer controlled
• 4 test
Femoral component undergoes flexion-
flexion-
stations
extension up to ±67°67°, anterior-
anterior-posterior
translation up to ±25mm • Servo-
Tibial component sees controlled rotation of hydaulics
±20°
20° • ISO14243-1
Axial load up to 4,500N Implants for
Speed of up to 2Hz surgery -
wear of total
Load cell at each test station
knee-joint
Designed to run unattended 24 hours per day prostheses
 EndoLab® spinal simulator Spine
6 wear stations Six-
Six-station spine
2 load-
load-soak stations flexion tester from
Separate load profiles Prosim
for lumbar and cervical Pneumatic actuation
disc replacements Spine wear simulator
Load applied via being developed
hydraulic components
Physiological testing
fluid at 37°
37°C

Friction Overview of this lecture

Specialist equipment is Why do we test artificial joints?
available, i.e from
How do we test artificial joints?
Prosim
For hip and knee Testing artificial hip joints
implants Testing other artificial joints
Single-
Single-station machine
Offers tribological data

Next lecture….
On Monday 2 November, no lecture
this Friday
If the majority of artificial joints fail
due to wear, why not just undertake
wear tests on the materials?
Such wear screening rigs are much
less complex and less expensive
than joint simulators