1. Design of a Rotational Stability Measurement Device For Analysis of ACL Reconstruction University of Pittsburgh Senior Design – BioE 1160/1161 Stephanie Bechtold Katie Dillon Kara Wagner Mentor: Thore Zantop, M.D. April 18, 2005

2. Goal To develop and test a novel device to measure the rotational stability of the knee after an Anterior Cruciate Ligament (ACL) reconstruction

3. ACL anatomy Two distinct fiber bundles Anteromedial (AM) Translational stability Posterolateral (PL) Rotational stability www.aclsolutions.com/ images

4. Current Reconstruction Methods Single bundle Restore only the AM bundle Susceptible to reinjuries by pivoting Double bundle Restores both AM and PL bundles More anatomically correct

5. Devices to Evaluate ACL Reconstruction Current devices only measure translational stability of the knee Double bundle technique creates need for device to measure rotational stability Evaluate effectiveness of PL bundle reconstruction http://www.medmetric.com/kt1.htm http://www.aircast.com

6. Problem Statement A device is needed to measure the rotational stability of the knee Comprehensive analysis of reconstruction techniques An immobilization device is needed to comfortably restrict movement in the hip and ankle joints Ensure pure rotation of the knee is measured

7. Market Considerations Market size 16,000 Orthopedic Surgeons (AAOS) Predicate Devices KT1000: $3900 Rolimeter: $850

8. Adjust boot to keep ankle immobile Fix knee at various flexion angles (0, 30, 45, 60, 90 degrees) Comfortably immobilize hip Consistently and safely apply known moment Collect repeatable data Initial Design Considerations

9. Universal force-moment sensor (JR3, Woodland, California) Prototype Development- Boot Aircast® Pneumatic Walker Brace Nest of Birds Ascension Technology Corporation, Burlington, VT/USA Photos courtesy of Ferguson Lab

10. Adjust boot to keep ankle immobile Fix knee at various flexion angles (0, 30, 45, 60, 90 degrees) Comfortably immobilize hip Consistently apply known moment Collect repeatable data Initial Design Considerations

11. Prototype Development- Hip Brace Lateral Decubitus position Wheelchair leg rest

12. Adjust boot to keep ankle immobile Fix knee at various flexion angles (0, 30, 45, 60, 90 degrees) Comfortably immobilize hip Consistently and safely apply known moment Collect repeatable data Initial Design Considerations

13. Prototype development Redesign of initial prototype Patient placed in supine position Lower leg horizontal Adjustable leg rest Knee flexion angle Length of femur Minimize metal components

14. Prototype Fabrication

15. Materials Selection Constructed of acrylic Eliminates metal components Minimizes interference with magnetic sensors Durable Comfortable for patient

16. Evaluation of Device 4 subjects - at 3 flexion angles 5 trials each Ensure repeatability Goal: Range of motion within ±1° Subject reports stability of ankle and hip joints

17. Experimental Methods Subjective knee evaluation performed by a clinician to determine health of knee Subject fitted with boot and brace to comfort Nest of Birds (NOB) sensors placed on Proximal Tibia Distal Femur Front of Boot

18. Experimental Methods Lower leg leveled at horizontal Creates neutral start position Moment applied by clinician (10Nm) Range of motion recorded by Nest of Birds

19. Experimental Methods

20. Sample Results

21. Preliminary Results Range of Motion, in degrees 4 subjects, 5 trials each Flexion AngleSubject 1Subject 2Subject 3Subject 4 0 degrees40.75 ± 1.762.20 ± 1.443.40 ± 1.564.40 ± 1.9 45 degrees49.60 ± 1.852.00 ± 1.031.60 ± 0.957.00 ± 0.7 90 degrees37.00 ± 1.637.00 ± 0.727.20 ± 1.554.20 ± 1.8

22. Adjust boot to keep ankle immobile Fix knee at various flexion angles (0, 30, 45, 60, 90 degrees) Comfortably immobilize hip Consistently and safely apply known moment Collect repeatable data Initial Design Considerations

23. Discussion Range of motion was repeatable within ±2° for all subjects Subjects reported ease of use and comfort of the boot and brace Overall apparatus is heavy for operator

24. Competitive Analysis Our Device Strengths More comprehensive analysis of ACL reconstruction Weaknesses Complex design Higher cost Predicate Devices Strengths Lightweight Simple design Weaknesses Limited analysis of reconstruction techniques Race for “first to market” Competition to develop similar device

25. Constraints limiting Phase I testing IRB approval Create baseline data for normal subjects Overhead cost of measurement devices

26. Quality System Considerations Class I device: non-invasive Human factors Biocompatibility Ease of use for clinician Patient’s Comfort Ethical issues Broad range of normal subjects Reduce cost

27. Future Streamline design Minimize cost Lower weight of apparatus Testing on reconstruction patients Evaluate effectiveness of technique Possible combination device based on KT1000 or Rolimeter To measure both translational and rotational stability in the same device

28. Acknowledgements Kevin Bell M.S. Volker Musahl M.D. Ryan Costic M.S. Larry Herman Department of Bioengineering Drs. Hal Wrigley and Linda Baker

29. IKDC form Standard, subjective knee evaluation Patient History of injury Symptoms Activity Level Clinician Translational stability evaluated using KT1000 or rolimeter Subjective evaluation of rotational stability

30. Background 100,000 ACL reconstructions per year 6 th most common orthopedic procedure in the US Debate over best method Single vs. double bundle Complex anatomy AM bundle - translation PL bundle - rotation Courtesy of Ferguson Lab

31. Work Breakdown Kara Wagner Background research, contact with machine shop Katie Dillon Testing Stephanie Bechtold Solidworks prototype Everyone Design History File, SBIR

32. Milestones Initial meeting with mentor – October 2004 Initial draft of design history file – December 8, 2004 Initial draft of SBIR – December 17, 2004 Ordered materials – First week of March 2005 Completed Solidworks – Third week of March Prototype Completed – Last week of March Preliminary testing – First week of April