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Competitor Products
ACL Injury/ \
70% Non contact
30% contactDeceleration + cutting, Lateral Blow
pivoting,
Anterior Blowside stepping,
(Hyperextension)
Awkward landings
Forces Which May Cause Injury
Ligament Injury
Anterior tibial translation and internal torque loads can injure the ACL or stretch out a graft.
Ligament Injury
Increased medial joint opening during lateral blows, which occur in contact sports, can injure both the MCL and ACL.
Ligament Injury
Hyperextension of the knee if knee is straightened more than 10º
beyond the
fully extended position
Ligament Injury
Small knee flexion angles at initial contact during landing tasks may contribute to “non-
contact”
ACL injuries.
252 million USD (2006)
Innovation Sports –
19 million USD (2005)
Medistox
–
14 million USD (2005)
Royce Medical –
68 million USD
Gibaud
–
55 million USD
Sales 2006 -
79 million USD
Sales 2006 International Sports Medicine –
2.8
million USD
DonJoy pedigree
Ex-DonJoy expertise inc. Pat Cawley
(R&D)
UK expertise –
ex S&N DonJoy and Medi
UK base is Hereford
Medi
Bayreuth –
parent company
Interest in FGP of Italy
Profit 05/06 after tax £485,000
Injection of capital from Medi
Bayreuth (£550,000)
Principal business –
distribution of medical support stockings and orthopaedic supports
Removed from Companies House register
Orthopaedics and Phlebology
Sales 2004 £4.4million
Sales 2005 £7.8million
Net debt increased to £1.375million
Decrease in cashflow
over the period
Manufacture in Scotland
Based in Blackburn
Acquisition of Able 2 (Netherlands) ADL
Distribute RoTen
braces
Protex
ROM
Previously in the UK ~ 1993
Current law-suit for patent infringement with GII (Ossur)
History of non-
representation in the UK
Distributed by Prestige Rehabilitation
Active Braces
DJO ACL/PCL LIGAMENT BRACESACTIVE BRACES
! 4 POINT DESIGN !
Actively addresses instability at all times
Active vs. Passive Braces
The tibial control component encompasses the tibia and parallels the tibial crest to help inhibit anterior and pivotal tibial excursion caused by ACL laxity. The non-elastic upper cruciate
strap provides an opposing force on the femur to help stabilize the knee.
A six-point system helps provide excellent medial and lateral support. The rigid graphite frame's lateral arms, condylar
support at the joint and non-elastic Velcro straps help inhibit medial and lateral instability. Blue arrows indicate support opposing valgus forces; white arrows indicate support opposing varus
forces.
Competitive Testing
Mechanical Evaluation of “Off the Shelf”
and Custom Knee Braces: Parameters of Stability and Component
Failure
Mahar
A, Oka R, Odell T, Wedemeyer
M
Department of OrthopedicsChildren’s Hospital, San Diego
Department of OrthopedicsUniversity of California, San Diego
Competitive Testing
Methods•
11 braces (n=3 of each) from 6 manufacturers
•
All braces were new, representing those most currently available on the market
Manufacturer Model Custom/OTSDonJoy Armor OTS
4titude FP OTSDefiance Custom
Breg Fusion Custom=OTS*X2K Custom=OTS*
Innovation Sports Edge OTSCTi2 Custom
Townsend Rebel OTSPremier Custom
Medi M4 OTSGeneration II 3DX Custom=OTS*
*Vendors report identical biomechanics between Custom and OTS
Competitive Testing
Methods•
Varus
stiffness
•
Valgus stiffness
Competitive Testing
Methods•
Strap tab stiffness
•
Strap tab failure strength
Competitive Testing
Methods•
Hyperextension stiffness
•
Hyperextension failure strength
Competitive Testing
Results –
Valgus / Varus
Stiffness
0
50
100
150
200
250
300
350
400
450
500
4titude FP Armor Defiance Rebel Premier Fusion X2K CTi 2 Edge 3DX M4
Bra
ce S
tiffn
ess
(lb/in
)
Valgus Varus
NEW
Competitive Testing
Results –
Strap Tab Stiffness
0
200
400
600
800
1000
1200
1400
1600
4titudeFP
Armor Defiance Rebel Premier Fusion X2K CTi 2 Edge 3DX M4
Stiff
ness
(lb/
in)
NEW
Competitive Testing
Results –
Hyperextension Stiffness
0
10
20
30
40
50
60
70
80
4titudeFP
Armor Defiance Rebel Premier FusionLateral
FusionMedial
X2K CTi 2 Edge 3DX M4
Avg
Hin
ge S
tiffn
ess
(in-lb
/deg
)
NEW
NEW
Competitive Testing
ResultsComposite Scores for Six Biomechanical Parameters of Stability and
Component Failure
Med
i M.4
Gen
erat
ion
II 3D
X
Breg
X2K
Tow
nsen
d Reb
el
Breg
Fus
ion
Inno
vatio
n Sp
orts
Edg
e
Inno
vatio
n Sp
orts
CTI
Don
Joy
Arm
o r
Don
Joy
4titu
de F
P
Don
Joy
Def
ianc
e
Towns
end
Prem
ier
-1.25
-0.75
-0.25
0.25
0.75
1.25
NEW
Competitive Testing
Conclusion
Extra ACL Protection
FourcePoint
Hinge
FourcePoint
Why is added ACL protection needed?
•
>75% of all ACL ruptures are non-contact•
Women are up to 10X more likely to suffer a non-contact ACL injury than men
•
Non-contact ACL injuries frequently occur during stop- jump activities
Forward Vertical Backward
FourcePoint
What puts ACL at risk? •
Joint angles less than 600
(Beynnon; Markolf)
p p
FourcePoint
How does it perform clinically?
Immediate Effects of a Knee Brace With a Constraint to Knee Extension on Knee Kinematics and Ground Reaction Forces in a Stop-Jump TaskBing Yu,*† PhD, Daniel Herman,† MS, William Lu,‡ PhD,Donald T. Kirkendall,† PhD, and William E. Garrett,† MD, PhDFrom the †University of North Carolina at Chapel Hill, Chapel Hill, North Carolina,and the ‡University of Hong Kong, Hong Kong
No author or related institution has received financial benefit from research in this study.
The American Journal of Sports Medicine, Vol. 32, No. 5DOI: 10.1177/0363546503262204© 2004 American Orthopedic Society for Sports Medicine
FourcePoint
Objective•
Determine the effects of a specially designed knee brace on the lower extremity kinematics & kinetics of athletes in a stop-jump task in which non-contact ACL injuries frequently occur
FourcePoint
Study Design•
12 male & 12 female recreational athletes 18-28 years old
•
3-D coordinates of reflective markers placed on selected critical body landmarks
•
5 trials with & without the new brace for each subject
FourcePoint
Results•
Brace wearers flexion angle increased ~5o
Knee Flexion Angle at Landing
0
5
10
15
20
25
30
35
Male Female
Deg
rees
No Brace Brace
p = 0.001
p = 0.001
FourcePoint
Does 5o
flexion angle increase matter?
•
The anterior shear force applied on the tibia will be reduced by 9% for females & 13%
for males (Nuley
et al.,
2002)•
The decrease in anterior shear force on the tibia will substantially reduce the load on the ACL
Competition
EDGE
Carbon fibre frame
Off the Shelf
Accutrac
hinges
Carbon fibre
Extension stops 0-10, 10-20, 20-
30 and 30-40
MORPH
Off the Shelf
Accutrac
hinges
Transforming Cuff Technology
Quick release buckles
Carbon fibre
Flexion and extension stops (0-40 and 45-90)
MotoX
market
Adjustable lateral cuffs
X2K OTS and Custom
T6 aircraft aluminium
0, 10, 20, 30 and 40 ext stop
45, 60, 75 and 90 flexion stop
Powdercoat
(ex Plastisol)
Valgus control (diamond design)
Nylon stops
Womens
and Compact versions
FUSION Product Line
XT (contact sports) Women’s Men’s OA
Medi
M4 –
6 sizes
Physioglide
hinge
Hinge shortens in extension
Hinge lengthens in flexion
Avional
aluminium frame
Soft grip padding
Ext 0,10,20,30 and 45
Flexion 0,10,20,30,45,60,75,90
Immob
0,10,20,30,45
Medi
Premier Lite
Same function as M4
Lightweight
Colour
Price ?
Softec
Genu
6 sizes
Knitted material
Tension-stable inelastic 4 Point stabilisation
Compression
Proprioception
Hinges adapt independently (3D)
SecuTec
-
Genu
Axiom OTS
6 sizes XS –
XXL
Metallic Alloy
Ratchet strapping
No catch hinge
Pivoting calf strap
Taller on lateral aspect
Lower on medial sections for comfort
Conclusion
Protection With A Brace??
DJO v’s
Competition
Ligament Injury
Anterior tibial translation and internal torque loads can injure the ACL or stretch out a graft.
Anterior Tibial Translation Protection
4 point braces only•
All DJO Braces
•
Medi
M4•
Medi
Premier Lite
Ligament Injury
Increased medial joint opening during lateral blows, which occur in contact sports, can injure both the MCL and ACL.
Lateral Blow Protection
•
All DJO braces
•
Ossur (CTi)
•
Bregg
•
Bledsoe
Ligament Injury
Hyperextension of the knee if knee is straightened more than 10º
beyond the
fully extended position
Hyperextension Protection
•
All DJO braces
•
Ossur (CTi)
•
Bregg
•
Bledsoe
Ligament Injury
Small knee flexion angles at initial contact during landing tasks may contribute to “non-
contact”
ACL injuries.
Small Knee Flexion Angle Protection
Fourcepoint
Hinge Only!!
Tibial Translation
Lateral Blow
Hyper- extension
Small Flexion Angle
DJO
Ossur
Bregg
Medi
Bledsoe
DJO Braces are the ONLY
Braces to give all round ligament protection
Questions?