ACL Injury. Forces Which May Cause Injury. / \ 70% Non contact 30% contact. Deceleration + cutting, Lateral Blow. side stepping, Awkward landings

Transcription

1 Competitor Products

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

3 Ligament Injury Anterior tibial translation and internal torque loads can injure the ACL or stretch out a graft.

4 Ligament Injury Increased medial joint opening during lateral blows, which occur in contact sports, can injure both the MCL and ACL.

5 Ligament Injury Hyperextension of the knee if knee is straightened more than 10º beyond the fully extended position

6 Ligament Injury Small knee flexion angles at initial contact during landing tasks may contribute to noncontact ACL injuries.

7

8 252 million USD (2006) Innovation Sports 19 million USD (2005) Medistox 14 million USD (2005) Royce Medical 68 million USD Gibaud 55 million USD

9 Sales 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

10 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

11 Removed from Companies House register Orthopaedics and Phlebology

12 Sales million Sales million 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

13 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

14 Active Braces DJO ACL/PCL LIGAMENT BRACES ACTIVE BRACES! 4 POINT DESIGN! Actively addresses instability at all times

15 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.

16 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

17 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 OTS Defiance Custom Breg Fusion Custom=OTS* X2K Custom=OTS* Innovation Sports Edge OTS CTi2 Custom Townsend Rebel OTS Premier Custom Medi M4 OTS Generation II 3DX Custom=OTS* *Vendors report identical biomechanics between Custom and OTS

18 Competitive Testing Methods Varus stiffness Valgus stiffness

19 Competitive Testing Methods Strap tab stiffness Strap tab failure strength

20 Competitive Testing Methods Hyperextension stiffness Hyperextension failure strength

21 Competitive Testing Results Valgus / Varus Stiffness Valgus Varus Brace Stiffness (lb/in) NEW titude FP Armor Defiance Rebel Premier Fusion X2K CTi 2 Edge 3DX M4

22 Competitive Testing Results Strap Tab Stiffness Stiffness (lb/in) titude FP NEW Armor Defiance Rebel Premier Fusion X2K CTi 2 Edge 3DX M4

23 Competitive Testing Results Hyperextension Stiffness Avg Hinge Stiffness (in-lb/deg) titude FP NEW Armor Defiance Rebel Premier Fusion Lateral NEW Fusion Medial X2K CTi 2 Edge 3DX M4

24 Competitive Testing Results Composite Scores for Six Biomechanical Parameters of Stability and Component Failure 1.25 DonJoy Armor DonJoy 4titude FP DonJoy Defiance Townsend Premier Innovation Sports CTI Innovation Sports Edge Breg Fusion Townsend Rebel Breg X2K NEW Generation II 3DX Medi M

25 Competitive Testing Conclusion

26 Extra ACL Protection FourcePoint Hinge

27 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 stopjump activities Forward Vertical Backward

28 FourcePoint What puts ACL at risk? Joint angles less than 60 0 (Beynnon; Markolf) p p

29 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: / American Orthopedic Society for Sports Medicine

30 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

31 FourcePoint Study Design 12 male & 12 female recreational athletes years old 3-D coordinates of reflective markers placed on selected critical body landmarks 5 trials with & without the new brace for each subject

32 FourcePoint Results Brace wearers flexion angle increased ~5 o Knee Flexion Angle at Landing No Brace Brace 35 p = p = Degrees Male Female

33 FourcePoint 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

34 Competition

35 EDGE Carbon fibre frame Off the Shelf Accutrac hinges Carbon fibre Extension stops 0-10, 10-20, and 30-40

36 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

37 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

38 FUSION Product Line XT (contact sports) Women s Men s OA

39 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

40 Medi Premier Lite Same function as M4 Lightweight Colour Price?

41 Softec Genu 6 sizes Knitted material Tension-stable inelastic 4 Point stabilisation Compression Proprioception Hinges adapt independently (3D)

42 SecuTec - Genu

43 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

44 Conclusion

45 Protection With A Brace?? DJO v s Competition

46 Ligament Injury Anterior tibial translation and internal torque loads can injure the ACL or stretch out a graft.

47 Anterior Tibial Translation Protection 4 point braces only All DJO Braces Medi M4 Medi Premier Lite

48 Ligament Injury Increased medial joint opening during lateral blows, which occur in contact sports, can injure both the MCL and ACL.

49 Lateral Blow Protection All DJO braces Ossur (CTi) Bregg Bledsoe

50 Ligament Injury Hyperextension of the knee if knee is straightened more than 10º beyond the fully extended position

51 Hyperextension Protection All DJO braces Ossur (CTi) Bregg Bledsoe

52 Ligament Injury Small knee flexion angles at initial contact during landing tasks may contribute to noncontact ACL injuries.

53 Small Knee Flexion Angle Protection Fourcepoint Hinge Only!!

54 Tibial Translation Lateral Blow Hyperextension Small Flexion Angle DJO Ossur Bregg Medi Bledsoe

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

56 Questions?