Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention Brace

1. Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention Brace Lawrence Technological University BME Senior Projects 1 Dr. Mansoor Nasir, Fall 2013 Faculty Advisor: Dr. Eric Meyer, PhD Technical Advisor: Ken Cook, P.E. Rachel Porter Dan Greenshields Justin Killewald

2. Agenda • Problem • Need Statement • Background • Knee Anatomy • Knee Mechanics • Knee Injuries • ACL Injuries • ACL Injury Mechanisms • Objective • Current progress/Future plans • Research plan • Design Process • Patent • Testing • Cost & materials • Timeline • Tasks & responsibilities

3. Problem • Knee injuries account for approximately 60% of all sports related injuries. Nearly half of those injuries occur to the ACL [1]. • Extensive recovery time ~ 8-12 months

4. Need Statement • An improved knee brace forACL injury prevention could help lower the injury rate in athletes. • Short term benefits • In turn, this potentially could delay the onset of further knee complications later in life. • Long term benefits

5. Design • ACL braces • Prevent hyperextension • Prevent valgus bending • Osteoarthritis braces • Unicompartmental loading • Include design characteristics of prevention braces

6. Knee Anatomy • Bones • Ligaments • Menisci • Cartilage • Muscles/tendons [2] http://www.webmd.com/pain-management/knee-pain/picture-of-the-knee

7. Knee Motions • Sagittal • Flexion • Extension • Coronal/Frontal • Valgus bending • Varus bending • Axial • Internal rotation • External rotation

8. Knee Injuries • Bone fracture • Torn ligament • ACL • PCL • MCL • LCL • Torn meniscus • Lateral • Medial • Osteoarthritis [7]

9. ACL Injuries • 200,000 – 300,000 ACL injuries/year in the U.S. [3] • 70% of injuries are non-contact [4] • Females are 3-10 times more likely to sustain injury [5] • Stop-jump landing and cutting [5] • Most common injury position: < 30° of flexion http://bretcontreras.com/wp-content/uploads/q-angle-men-vs-women.jpg

10. ACL Injury Mechanisms • Internal rotation • Foot planted as body twists • Anterior shear of tibia • Foot planted as knee is hit from the front • Axial Load • Compressive force causes tibial slipping (5500 N) [4] • Hyperextension • Tension on ACL causes tearing • Valgus bending • Knee is angled towards center of body

11. Objective • Redesign OA brace hinge to prevent hyperextension, valgus bending, and axial loading on the knee joint to protect the ACL • Research plan • Hinge design • Patent filing • Human subject testing

12. Current ACL Braces • Donjoy Defiance – clinically proven brace • Decreases ACL strain [6] • FourcePoint hinge • Protects against hyperextension and valgus bending • Worn by many college and NFL linemen http://www.djoglobal.com/products/donjoy/defiance

13. Osteoarthritis Braces • Commonly used by elderly population • Medial compartment most affected by OA. [8] • Offload medial compartment to even the distribution on compartments • Unicompartmental loading • Medial/lateral

14. Modified Hinge Design • Polycentric gears  Spider gears • Hypothesis • Lateral hinge = polycentric • Medial hinge = spider gear • Stainless Steel • Both hinges – prevent hyperextension • Medial hinge – shifts loading mechanism • Lateral hinge – prevent valgus bending

15. Modified Hinge Design cont. • Polycentric normal action • Compressive loading – flexed action

16. Patent Filing Process http://www.uspto.gov/patents/process/index.jsp

17. Current Patent Search • Hundreds of knee brace patents • OA brace • ACL brace • Individual components patented • Hinge - consistent • Strap • Frame

18. Future Patent Filing • Our design has not been patented • Two different hinges on our brace • Start process in January • Finish and file in May • Could take years to get full patent approval

19. Institutional Review Board (IRB) • Department of Health and Human Services • Protect the rights and welfare of human subjects • Monitor research development, testing and evaluation methods • Submitted for IRB approval • Application • Consent form • Participant info sheet http://www.irbservices.com/irbservices/Choose_IRBS_files/IRBS%20Master%20Logo.png

20. Current Testing Techniques • 3D motion capture • 20 participants • Stop-jump landings • With and without brace • Measured • Knee flexion angle • Ground reaction forces • [5]

21. Experimental Method • 2 participants • Jump landing trials onto force plates • 3 tests • Without brace • With Donjoy Defiance brace • With redesigned brace • Measure • Ground reaction force • Segment acceleration • Joint reaction force • Moment • Materials • Vicon Nexus • Polygon http://bjsm.bmj.com/content/early/2010/06/16/bjsm.2009.069351/F2.large.jpg

22. Cost & Materials • Braces = $1000 • Donjoy OA Defiance Brace • 1 male and 1 female • Hinge redesign material = $500 • Springs, screws, washers, stainless steel • Testing supplies = $300 • Velcro, double sided tape • LESA foundation - $1000 granted

23. Timeline

24. Anticipated Challenges • Not a significant decrease in compressive load forces • Time restrictions • Failed IRB approval • Patent filing

25. Tasks & Responsibilities • Individual tasks • Rachel Porter • Institutional Review Board (IRB) filing • Dan Greenshields • Existing knee brace patent search • Patent application • Justin Killewald • Hinge design research • Materials used in braces • Shared tasks • Prototype design & fabrication • Testing • Data analysis • Presentation creation • Final report documentation

26. References • [1] Rishiraj, Neetu, Jack E. Taunton, Robert Lloyd-Smith, Robert Woollard, William Regan, and D.B. Clement. "The Potential Role of Prophylactic/Functional Knee Bracing in Preventing Knee Ligament Injury." Sports Medicine 39.11 (2009): 937-60. Print. • [2] http://www.webmd.com/pain-management/knee-pain/picture-of-the-knee • [3]Teng, Phillis S.P., K.F. Leong, P.Y. Huang, and J. McLaren. "The Effect of a Knee-ankle Restraint on ACL Injury Risk Reduction during Jump-landing." Procedia Engineering60 (2013): 300-06. Print. • [4] Meyer, Eric G., and Roger C. Haut. "Excessive Compression of the Human Tibio-femoral Joint Causes ACL Rupture." Journal of Biomechanics 38.11 (2005): 2311-316. Print. • [5] Yu, B. "Immediate Effects of a Knee Brace With a Constraint to Knee Extension on Knee Kinematics and Ground Reaction Forces in a Stop-Jump Task." American Journal of Sports Medicine 32.5 (2004): 1136-143. Print. • [6] http://www.djoglobal.com/education/patient-education/acl-bracing • [7]Majewski, M., H. Susanne, and S. Klaus. "Epidemiology of Athletic Knee Injuries: A 10-year Study." The Knee 13.3 (2006): 184-88. Print. • [8]Gaasbeek, Robert D.A., Brenda E. Groen, BriekeHampsink, Ronald J. Van Heerwaarden, and Jacques Duysens. "Valgus Bracing in Patients with Medial Compartment Osteoarthritis of the Knee A Gait Analysis Study of a New Brace." Gait & Posture26 (2007): 3-10. Print.

27. Questions?