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?