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Masters Programme

Biomedical Engineering

Modern Implants in orthopaedic Trauma

Arndt P Schulz, MD, MRCS (Glasgow)


University Hospital Lübeck, Dept Trauma and Orthopaedics
Klaus Seide, MD, PhD
BG Trauma Hospital Hamburg, Biomechanical Laboratory
Orthopedic surgeons have a
broad variety of implants
for external and internal
stabilisation of fractures
and luxations
Implants
(e.g for the distal femur)

External fixator
Implants
(e.g for the distal femur)
Screws
patient, female, 37 y.: distal femoral fracture type B2
caused by a fall down the stairs ; treated with 3 screws
Implants
(e.g for the distal femur)
Conventional plate systems:

•Condylar plate (so


called Burri-plate)

•95° angular blade plate


•Dynamic condylar screw
(DCS)
patient female 60 y.: distal femoral fracture
type A1 caused by a simple fall due to osteoporosis;
treated with a DCS
Implants
(e.g for the distal femur)

Intramedullar
nails
patient, male, 40 y.: A1 distal femoral fracture type
A1 caused by a car accident ; treated with an
intramedullary nail
Implants
(e.g for the distal femur)
Angular stable internal fixators with
locked screws
patient, female, 18 y.: distal femoral fracture type
C3 caused by a car accident ; treated with an angular stable
internal fixator
….and now let‘s have a
closer look on internal
fixators or implants with
locked screws or angular
stable implants
How to define
angular stability ?

strong, longlasting but


reversible union of
screws and longitudinal
stabilisator (plate, nail
or external fixator rod)
(Wolter 1985)
Biomechanical principle I
conventional plate- internal plate fixator
osteosynthesis

Seide et al. 1999


Biomechanical principle II

conventional
plate-
osteosynthesis

internal plate
fixator
Why do we need internal fixators?

1. Higher and first of all


longerlasting stability.
2. More independence from
bone quality than in
conventional plating.
3. Biological reasons. The
blood supply of the bone
by the periostium is less
disturbed due to a
diminished pressure on
the bone by the plate.
Different solutions
Unidirectional,
monocortical screw
positioning without any
contact betweeen bone
and plate

Multidirectional,
bicortical screw
positioning and contact
betweeen bone and
plate without pressure
Different Implants
Less invasive stabilisation System (LISS)

•Unidirectional,
monocortical screws
Multidirectional internal plate fixators
Pressure-Plate-Fixator
(PPF)
Titanium Internal-Fixateur (TiFix)

cervical, thoracical 1st generation; distal


and lumbar spine femur, tibia

femur 2nd generation;


the rest of the
body
First Solution in 1931 by Dr
Reinhold/ Paris
First modern solution to produce an
angular stable screw-plate interface
Multidirectional internal fixator for the thoracic and
lumbar spine 1985 - Pressure plate principle

Angular stability by locking the head of


the screw in the plate hole with
l t
Stabilisation of a fracture of the
1. lumbar vertebral body by a PPF
Pressure-Plate-Fixator (PPF)
for the femur
`83 `85
First patient
treated with a
PPF
*1941
injured in 1983

`87 `93
Bony consolidation in
9/1993
Minimal invasive osteosynthesis
of the femur by a PPF
Second solution to produce a
locked screw-plate interface
Plate: „softer“ Material (e.g. titanium grade 1 )
Screw: „harder“ material (e.g. titanium grade 4
or 5, titanium alloy) 1992

Angular stability by material reshaping


TiFix 1st Generation

Thread-miller
TiFix 1st generation

The angle
between screw
and plate can be
choosen freely up
to 45° to each
direction !
TiFix 2nd Generation

„lip-construction“
No thread-miller
needed!
History of the development of multi-
directional internal plate fixators
1985 PPF lumbar and thoracic
spine
1991 PPF cervical spine
1993 PPF femur
1997 TiFix tibia
1998 TiFix calcaneus and
distal femur
1999 TiFix humeral head,
forearm and tibial head
First problem
Second problem
Solution?

Unilateral osteosynthesis of
tibial head by angular stable
butress plate
Biomechanical Study design
Comparison of unilateral osteosynthesis of tibial
head fractures by butress plate in angular stable
and conventional technique in fresh human
cadaveric tibial heads by biomechanical testing on
a servohydraulic material test machine.

The technique of plating (angular stable or


conventional) was the only variable.
Material
5 paired fresh human cadaveric tibial
heads cut down to a length of 45
millimeters

5 paarige humane Tibiakopfpräparate auf


45mm gekürzt.
Measurement of bone density
by computer tomography

European spine
phantom
Implant
Material testing machine

Biaxial, servohydraulic
material testing
machine MTS Typ
Bionix 858.2
Standardized preparation
X-ray controlled osteosynthesis
Testing assembly
LVDT

link joint Femoral part


of a knee
prothesis
Tibial head
plate

LVDT

X-Y-table
Testing protocol
„ preload 10N
„ sinus shaped, cyclic, force-induced load,
frequence 4 Hz
„ initial axial load 100 N
„ increase of load by 50 N every 2000
cycles until failure of the construct or 700 N
are reached (maximum 26000 cycles)
Results I
number bone density failure (at load in N )
(mg HA/cm³) angular stable conventional
1 146.8 600 350
2 63.1 >700 300
3 78.1 550 200
4 60.4 600 400
5 118.7 650 450
median 600 350

min 550 200


max >700 450
Results II
number varus motion at 100N (mm) offset at 100N (mm)
angular stable conventional angular stable conventional
1 0.113 0.139 0.444 0.424
2 0.003 0.087 0.269 0.425
3 0.146 0.631 0.331 1.207
4 0.253 0.269 0.294 0.268
5 0.06 0.139 0.201 0.350
median 0.113 0.139 0.294 0.424

min 0.003 0.087 0.201 0.268


max 0.253 0.631 0.444 1.207
Summary

• The angular stable construct showed in


every single test a significant higher
stability in comparison to the conventional
construct (p < 0,05)

• The increase of stability concerning varus


motion and offset reached up to 500%.

• A loosening of the angular stable screw-


plate interface was seen in no case
And in the Future…?

Routine Load Measurements in


internal Fixator Systems
¾ Monitoring of Fracture Healing
¾ Optimisation of postoperative Treatment
Concept

¾ Locked Implant
¾ DMS Sensors
¾ Microelektronic/Telemetry
¾ Encapsulation
Telemetry

Energy
µC based
RF-Interface transponder
Data

Transponder

Power
coil
Display

µC based Reader Readout circuit


coil
control unit

Sensor

Application
PC with custom-designed
software

External Electronics Implantable System


Transponder with Sensor-Interface
Implants for Tibia and Femur
Readout
Biomechanic in vitro testing

Biegung senkrecht zur Plattenebene


unter simulierten Frakturbedingungen

300

F4
F5
F6
200 F7
F8
F9
F10
F11
100
F12
F13
F14
F15
F16

µV/V
0
F17
0 100 200 300 400 500 600 700 800 900
F18
F19
F20
F21
-100
F22
F23
F24
F25
E1
-200
E5
E6

-300
New ton
In-vivo testing in sheep
Korrelation Fixateurbelastung vs. Kraft
y = 2,4677x + 35,171
(8 Kraftzyklen) 2
R = 0,9532
Steifigkeit: 0,41 N/(µm/m)
200,0

175,0

150,0
Fixateurbelastung (Dehnung [µm/m]

125,0

100,0

75,0

50,0

25,0

0,0
0,0 5,0 10,0 15,0 20,0 25,0 30,0 35,0 40,0 45,0 50,0
Externe Kraft [N]
Bluetooth-Readout
In-vivo use in Patients
Patient 2, 11.08.05, postop
600,0

500,0

400,0
Measured data

300,0

200,0

100,0

0,0
0,000 50,000 100,000 150,000 200,000

Time [s]
Kraft [N] Fixateur (A/D Code [dez])
Physiotherapy

Implantat-Biegebelastung bei KG-Übungen


600%

500%

400%
Prozent

300%

200%

100%

0%

Implantatbelastung unter 10kg max. Anspannung der OS- Anheben des Beines in KG-Übungen mit
axial Muskulatur Rückenlage Torsionskomponente
Outlook
¾ Routine Use
¾ Telemedical Patient Supervision
¾ Optimisation of postop. treatment regime
Future of External Fixation ?

First external fixator


(Wutzer, 1843)
Electronically Controlled („Intelligent“)
External Fixator Systems

Measurement of fracture healing


progress
Detecting delayed healing or
pseudarthrosis formation
Controlling patient activity by
display or voice
Actively controlling optimal load on
Force Sensors
the fracture gap (Dynamisation) Linear Control
Motors Unit

Actively performing fracture


reduction
Motor Driven Fixator
Motor Driven Fixator

08/2003 R.L.
Motor Driven Fixator

08/2003 R.L.
3-Dimensional Load Measurements
30
1 A3
25 2 A3
3 A3

Mxy (Nmm/N)
20 4 A3

bone 15

10

0
callus 2 4 8
Zeit (Wochen)
12 M

30
5 A2
6 A2
25
7 A2
fixator 8 B2

Mxy (Nmm/N)
20 9 C3
15

10

0
Fground 2 4 8
Zeit (Wochen)
12 M

30

25

20
Mxy (Nmm/N)

15

10 Patient A: delayed
fracture healing
5

0 Patient B: normal
fracture healing
2 4 8 12
time ( weeks )
Summary
„ Universal and precise 3-dimensional bone movements
„ Path of reduction / correction can be modified at any time
„ To be applied with different fixator systems
„ Painless fracture reduction

„ Motors and measurement additions possible („Intelligent Fixator“)

„ Very helpful addition to the treatment options


Thank You!

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