Competitor Products

ACL Injury Forces Which May Cause Injury / \ / \ 70% Non contact 30% contact Deceleration + cutting, Lateral Blow pivoting, Anterior Blow side stepping, (Hyperextension) Awkward landings

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.

Competitor Products

Active Braces DJO ACL/PCL LIGAMENT BRACES ACTIVE 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 Orthopedics Children’s Hospital, San Diego University 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/OTS DonJoy Armor OTS 4titude FP Defiance Custom Breg Fusion Custom=OTS* X2K Innovation Sports Edge CTi2 Townsend Rebel Premier Medi M4 Generation II 3DX *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 NEW

Competitive Testing Results – Strap Tab Stiffness NEW

Competitive Testing Results – Hyperextension Stiffness NEW NEW

Competitive Testing Results Composite Scores for Six Biomechanical Parameters of Stability and Component Failure 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 = 00

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 Task Bing Yu,*† PhD, Daniel Herman,† MS, William Lu,‡ PhD, Donald T. Kirkendall,† PhD, and William E. Garrett,† MD, PhD From 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. 5 DOI: 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

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

Competitor Braces – Ossur CTi custom CTi OTS Edge Morph (discontinued) C180

Ossur Advantages Disadvantages Well known ‘Accutrac’ hinges Extreme sports market Internationally recognised brand Customer service Employ Orthotists to fit and advise Disadvantages ‘Passive’ design ‘Bulky’ frame Do not guarantee the brace will protect! Slippage Causes damage to bike frame Expensive Charge for measuring

Competitor Braces - Breg Fusion Fusion womens Fusion XT X2K X2K high performance X2K womens X2K unlimited Compact X2K X2K - PTO

Breg Advantages Disadvantages Surgeon relationship Cost effective ‘Diamond’ design on X2K ‘Proform’ technology (sleek, lightweight, conforms to the leg) Fusion – protection from lateral impact Fusion significantly increased market share – 215 college teams now using the brace Patient compliance - comfort Disadvantages ‘Passive’ design Only for contact injuries Contradictory message between designs Poor quality Contact injuries occur in less than 30% of injuries Weaker than DJO braces in competitive testing study

Competitor Braces - Medi Standard Short

Medi Advantages Disadvantages Four point principal brace Low profile, light weight Smart extension stop kit Lower priced than DJO Customer relationships built through hosiery range Disadvantages Poor quality materials Hyper extends when extension stop removed No significant research studies Weakest brace in competitive bracing study Off the shelf only

Competitor Braces - Bledsoe Axiom OTS Axiom Sport Ultimate CI

Bledsoe Advantages Disadvantages Robust braces, option for reinforced brace ‘STAR’ programme Disadvantages Passive design Bulky and heavy No significant research AOP scan file required for custom brace

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