1 Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention Brace Rachel Porter Dan Greenshields Justin Killewald Lawrence Technological University BME Senior Projects 1 Dr. Mansoor Nasir, Fall 2013 Faculty Advisor: Dr. Eric Meyer, PhD Technical Advisor: Ken Cook, P.E. 2 Agenda Problem Objective Need Statement Current progress/Future plans Background Research plan Knee Anatomy Design Process Knee Mechanics Patent Knee Injuries Testing ACL Injuries Cost & materials ACL Injury Mechanisms Timeline Tasks & responsibilities 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 3 Need Statement An improved knee brace for ACL 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 4 Design ACL braces Prevent hyperextension Prevent valgus bending Osteoarthritis braces Unicompartmental loading Include design characteristics of prevention braces 5 Knee Anatomy Bones Ligaments Menisci Cartilage Muscles/tendons 6 [2] http://www.webmd.com/pain-management/knee-pain/picture-of-the-knee Knee Motions Sagittal Flexion Extension Coronal/Frontal Valgus bending Varus bending Axial Internal rotation External rotation 7 8 Knee Injuries Bone fracture Torn ligament [7] ACL PCL MCL LCL Torn meniscus Lateral Medial Osteoarthritis 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 ACL Injury Mechanisms Internal rotation Anterior shear of tibia Compressive force causes tibial slipping (5500 N) [4] Hyperextension Foot planted as knee is hit from the front Axial Load Foot planted as body twists Tension on ACL causes tearing Valgus bending Knee is angled towards center of body 10 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 11 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 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 13 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 14 Modified Hinge Design cont. Polycentric normal action Compressive loading – flexed action 15 Patent Filing Process http://www.uspto.gov/patents/process/index.jsp 16 Current Patent Search Hundreds of knee brace patents OA brace ACL brace Individual components patented Hinge - consistent Strap Frame 17 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 18 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 19 http://www.irbservices.com/irbservices/Choose_IRBS_files/IRBS%20Master%20Logo.png Current Testing Techniques 3D motion capture 20 participants Stop-jump landings 20 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 Cost & Materials Braces = $1000 Donjoy OA Defiance Brace 1 male and 1 female Hinge redesign material = $500 Testing supplies = $300 Springs, screws, washers, stainless steel Velcro, double sided tape LESA foundation - $1000 granted 22 Timeline Month Milestone January Assemble first prototype brace and begin human subject testing February Continue testing prototype and adjust design March Adjust design and continue testing Data analysis April Data analysis and interpretation May Prepare final report and presentation File provisional patent 23 Anticipated Challenges Not a significant decrease in compressive load forces Time restrictions Failed IRB approval Patent filing 24 25 Tasks & Responsibilities Individual tasks Shared tasks Rachel Porter Prototype design & fabrication Testing Data analysis Institutional Review Board (IRB) filing Dan Greenshields Existing knee brace patent search Presentation creation Patent application Final report documentation Justin Killewald Hinge design research Materials used in braces 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, Brieke Hampsink, 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. 26 Questions? 27