Competitor Products Forces Which May Cause Injury ACL

Competitor Products

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

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 Department of Orthopedics 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 Don. Joy Breg Innovation Sports Townsend Medi Generation II Model Armor 4 titude FP Defiance Fusion X 2 K Edge CTi 2 Rebel Premier M 4 3 DX Custom/OTS OTS Custom=OTS* OTS 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 NEW

Competitive Testing § Results – Strap Tab Stiffness NEW

Competitive Testing § Results – Hyperextension Stiffness NEW

Competitive Testing § Results NEW Composite Scores for Six Biomechanical Parameters of Stability and Component Failure

Competitive Testing § Conclusion

Extra ACL Protection Fource. Point Hinge

Fource. Point § Why is added ACL protection needed? • >75% of all ACL ruptures are non-contact • Women are up to 10 X more likely to suffer a noncontact ACL injury than men • Non-contact ACL injuries frequently occur during stopjump activities Forward Vertical Backward

Fource. Point § What puts ACL at risk? • Joint angles less than 600 (Beynnon; Markolf) p p = 00

Fource. Point § 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, *† Ph. D, Daniel Herman, † MS, William Lu, ‡ Ph. D, Donald T. Kirkendall, † Ph. D, and William E. Garrett, † MD, Ph. D From the †University of North Carolina at 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

Fource. Point § 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

Fource. Point § 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

Fource. Point § Results • Brace wearers flexion angle increased ~5 o

Fource. Point § Does 5 o 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) C 180

Ossur Advantages § § 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 § X 2 K • • • X 2 K high performance X 2 K womens X 2 K unlimited Compact X 2 K - PTO

Breg Advantages § § Surgeon relationship Cost effective ‘Diamond’ design on X 2 K ‘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 § M 4 • Standard • Short

Medi Advantages § § § 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 § 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 M 4 • 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 DJO Ossur Bregg Medi Bledsoe Lateral Blow Hyper- extension Small Flexion Angle

DJO Braces are the ONLY Braces to give all round ligament protection