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

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1 Novel Design of an Anterior Cruciate Ligament (ACL) Injury Prevention Brace Daniel Greenshields, Justin Killewald, Rachel Porter Lawrence Technological University BME Projects II Dr. Mansoor Nasir, Spring 2014 Faculty Advisor: Eric Meyer, Ph.D. Technical Advisor: Kenneth Cook, P.E., CCE 1

2 Background Approximately 200, ,000 ACL injuries in the U.S. per year 8-12 month recovery time Reconstructive surgery Females have a greater risk of injury than males Gender comparable sports Knee alignment or neuromuscular patterns 2

3 Knee Anatomy Meyer E, Haut R. Excessive compression of the human tibio-femoral joint causes ACL rupture. J Biomech. 2005;38:

4 Injury Mechanisms Hyperextension Valgus bending Internal rotation of the tibia Axial compressive loading [1] Sandes T., et al. "Bone Contusion Patterns of the Knee at MR Imaging: Footprint of the Mechanism on Injury."Radiographics 20 (2000): S ; [2] 4 [3] Koga, H., et al. "Mechanisms for Noncontact Anterior Cruciate Ligament Injuries: Knee Joint Kinematics in 10 Injury Situations From Female Team Handball and Basketball." The American Journal of Sports Medicine (2010):

5 Current Braces ACL braces Hyperextension and valgus bending Donjoy Armor Osteoarthritis (OA) braces Unicompartmental (usually medial) OA Typically reduce pressure on the medial compartment by offloading axial compressive load to lateral compartment 5

6 Project Goal Redesign a prophylactic knee brace to shift part of the axial compressive load from the lateral to the medial compartment of the knee Perform experimental human subject testing to validate the effectiveness of the hinge design 6

7 Design Goals Medial hinge redesign 1) Continue to protect against hyperextension and valgus bending 2) Position the knee in a slightly varus bending angle 3) Convert part of vertical ground reaction force (vgrf) into lateral displacement when knee is near full extension 7

8 Hinge Design Process Control Brace Rough Drawing AutoCAD Drawing Steel Prototype Aluminum Hinge Modified Hinge Brace 8

9 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 9

10 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 10

11 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 11

12 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 12

13 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 13

14 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 14

15 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 15

16 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 16

17 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 17

18 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 18

19 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 19

20 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 20

21 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 21

22 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 22

23 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 23

24 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 24

25 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 25

26 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 26

27 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 27

28 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 28

29 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 29

30 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 30

31 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 31

32 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 32

33 Hinge Design Replaced medial hinge on Donjoy s Armor Four rods Attached hinge to frame Two wedges Move in conjunction with the rods Work to compress springs when load is applied Move central to knee joint Press against wedge pad Creates lateral brace movement at knee joint Increases varus bending moment applied to the knee 33

34 Human Subject Testing Institutional Review Board (IRB) approval for biomechanical human subject testing Informed consent form Participant information sheet 2 subjects Male Female 3 experimental tests 34

35 Experimental Set-up Plug-In Gait Fullbody Marker Set 35 Plug-in Gait Product Guide Foundation Notes. Vicon, 2010.

36 Experimental Set-up Platform 30 cm drop Force plates Measure vgrf 3D motion capture system 8 cameras (Vicon Bonita) 36

37 Experiments 1) Step-off landing on both legs 30 cm drop 2) Step-off landing on one leg 30 cm drop 3) Run and stop jump 3 step approach run

38 Data Analysis Vicon Nexus Vicon Polygon 38

39 Data Analysis Vicon Nexus Vicon Polygon 39

40 Results Knee Flexion/Extension Angle Maximum Vertical Ground Reaction Force (x BW) Male Female Control Control Modified Control Modified 2 Leg Step Off 1.7 ± ± ± ±0.4 1 Leg Step Off 3.2 ± ± ± ±0.3 Run Stop Jump 1.3 ± ± ± ±0.2 Modified 40

41 Results: Step-off landing on both legs Male Knee Valgus/Varus Angle Graphs Female Control 16.7 ±4.6 Male increase in varus bending -6.3 ±2.4 Modified 33.7 ±8.6 Female went from valgus to varus bending 21.3 ±6.4 41

42 Results: Step-off landing on one leg 16.0 ±2.5 Male Knee Valgus/Varus Angle Graphs Female Control Male increase in varus bending -8.0 ±1.6 Modified 23.7 ±2.2 Female went from valgus to mostly varus bending 2.0 ±5.8 42

43 Results: Run and stop jump 18.0 ±1.7 Male Knee Valgus/Varus Angle Graphs -9.5 ±3.6 Female Control Male increase in varus bending Modified 28.3 ±2.6 Female went from valgus to mostly varus bending 5.8 ±2.8 43

44 Results: Valgus/Varus Moment Graphs Control Modified 44

45 Conclusion Validation tests for modified brace Full range of motion Hyperextension not seen Valgus angle reduced Reduced compressive load on lateral compartment Axial compressive load was shifted from lateral to medial compartment Indicated by frontal plane kinematics and kinetics 45

46 Project Logistics Budget LESA funding $1000 Item Price Hinge materials $ Fabrication tools $ Tasks & Responsibilities Team Member Dan Tasks & Responsibilities Hinge design and fabrication Testing materials $61.80 Donjoy Armor $ Total $ Rachel Justin IRB approval and human subject testing Data analysis and human subject testing 46

47 Future Implications More human subject testing Provisional patent filing Abstract to BMES Publication 47

48 Acknowledgements KERN Foundation for funding through LEGENDS Entrepreneurial Student Awards (LESA) Mike Greenshields for hinge parts Lawrence Technological University Fabrication Lab Dr. Eric Meyer - Lawrence Technological University Professor Ken Cook Lawrence Technological University 48

49 References Koga, H., A. Nakamae, Y. Shima, J. Iwasa, G. Myklebust, L. Engebretsen, R. Bahr, and T. Krosshaug. "Mechanisms for Noncontact Anterior Cruciate Ligament Injuries: Knee Joint Kinematics in 10 Injury Situations From Female Team Handball and Basketball." The American Journal of Sports Medicine (2010): Plug-in Gait Product Guide Foundation Notes. Vicon, Meyer E, Haut R. Excessive compression of the human tibio-femoral joint causes ACL rupture. J Biomech. 2005;38:

50 Questions 50

51 Results: Flexion/Extension Graphs Control Modified 51

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