1. | © Otto Bock HealthCare Microprocessor Control in Prosthetics & Orthotics. Andreas Kannenberg, MD PhD, Executive Medical Director North America

2. | © Otto Bock HealthCare 2 I © Otto Bock HealthCare Disclosure Andreas Kannenberg is a full-time employee of Otto Bock HealthCare LP, a manufacturer of prosthetic and orthotic components.

3. | © Otto Bock HealthCare Non-microprocessor controlled prosthetic knees 3 Knee flexion during weight bearing NoLimited Unlimited (yielding) Knee mechanism(s)  locked knee,  friction brake knee,  4-bar polycentric knee  polycentric knees with more than 4 axes,  knees with bouncing adapter  fluid control knees (mechanical or microprocessor-controlled) Terrains supported (+) or not supported (-) for negotiation  walking on level ground -no support of stance flexion for -shock absorption -walking on uneven ground -alternate slope and stair descent  walking on level ground,  stance flexion for shock absorption  walking on slightly uneven terrain  alternate descent of shallow slopes (≤5°) -no support of negotiation of heavily uneven terrain -no support of alternate descent of steeper slopes (>5°) -no support of alternate descent of stairs  walking on level ground,  stance flexion for shock absorption  walking on uneven terrain  alternate descent of slopes and stairs Stability*Function Stability ≠ Safety Safety = stability during level walking, + stability during walking on uneven terrains, slopes, stairs + toe clearance + stumble recovery *stability = prevention of knee collapse during level walking K1 / K2K2 / K3K3 / K4

4. | © Otto Bock HealthCare 4 Sensors to provide input for gait control software  Knee angle (+ velocity)  Ankle moment  Axial load  Knee moment  Shank inclination (+ velocity)  3D linear accelerations MP controlled Prosthetic Knees: examples

5. | © Otto Bock HealthCare 5 I © Otto Bock HealthCare MPK research (55 English language publications)  24 clinical trials with 290 patients  18 biomechanical studies with 168 patients  5 patient surveys with 368 patients  3 health-economic studies with 146 patients in 3 countries  2 systematic reviews

6. | © Otto Bock HealthCare 6 Safety of the C-Leg – Summary of systematic review “Five of these seven studies provide consistent, statistically significant findings of improvements in self-reported reduction of stumbles and falls and improved balance. Additional non-statistically significant improvements support the latter findings and include knee stability in conditions resulting in collapse of other knees and improved balance confidence.“ “In total, these seven studies provide a grade “B“ recommendation.“ Highsmith MJ, Kahle JT, Bongiorni DR, Sutton BS, Groer S, Kaufman KR: Safety, energy efficiency, and cost efficacy of the C-leg for transfemoral amputees: A review of the literature. Prosthet Orthot Int 2010, 34 (4): 362-377

7. | © Otto Bock HealthCare 7 Kahle JT, Highsmith MJ, Hubbard SL: Comparison of non-microprocessor knee mechanism versus C-leg on Prosthesis Evaluation Questionnaire, subles, falls, walking tests, stair descents, and preference. JRRD 2008, 45 (1): 1-14 Stumbles and falls on NMPKs vs. MPKs Average number of stumbles in 60 days on non-MP knee7 ± 3 on the MPK3 ± 4 (significant improvement, p=0.006) Average number of falls in 60 days on non-MP knee3 ± 3 on the MPK1 ± 2 (significant improvement, p=0.03)

8. | © Otto Bock HealthCare 8 non-MPK in the clinic MPK, 3 months later Courtesy of Michael Leach, CPO, Ottobock

9. | © Otto Bock HealthCare 9 Systematic review of MPK studies in K2 patients Kannenberg A, Zacharias B, Pröbsting E: Benefits of microprocessor prosthetic knees to limited community ambulators: A systematic review. J Rehabil Res Dev 2014; 51 (10): 1469-1495.

10. | © Otto Bock HealthCare Safety outcomes of MPKs in K2 amputees 10 StudyKahle et al. (2008)Hafner et al. (2009)Burnfield et al. (2012) Safety related outcome measures Number of stumbles and falls VAS on number and frequency of stumbles and falls, confidence while walking and frustration with falls Timed up and go test (TUG), Activity-specific Balance Confidence Scale (ABC scale) Results with statistical significance (p<0.05) in favor of the MPK Number of falls decreased 81% from 2.1±1.5 to 0.4±0.7 (p=0.05)*. Stumble frequency decreased 15.8% (p=0.05). Number of falls decreased 80% (p=0.01). Falls frequency decreased 4.5% (p=0.01). TUG decreased 28% from 24.5 s to 17.7 s (p=0.018). Balance (ABC) improved 26% from 60.1 to 75.7 (p=0.001). Results with statistical trend (p<0.10) in favor of the MPK none Confidence while walking improved 12% (p=0.08). Frustration with falls decreased 23.4% (p=0.06). none No statistical difference between MPK and NMPK Number of stumbles Embarrassment with falls Number of stumbles Frequency and number of semicontrolled falls none Results with statistical significance (p<0.05) or trend (p<.10) in favor of the NMPKs none *post-hoc statistical analysis of published raw data using the Wilcoxon signed rank test Kannenberg A, Zacharias B, Pröbsting E: Benefits of microprocessor prosthetic knees to limited community ambulators: A systematic review. J Rehabil Res Dev 2014; 51 (10): 1469-1495.

11. | © Otto Bock HealthCare Performance-based function and mobility outcomes 11 *post-hoc statistical analysis of published raw data using the Wilcoxon signed rank test StudyKahle et al. (2008)Hafner et al. (2009)Theeven et al. (2011)Theeven et al. (2012) Study outcome measures related to function and mobility Walking tests on level and uneven ground, stairs performance (MRPP), MFCL Walking tests on hills and stairs, dual task performance, Amputee Mobility Predictor (AMP) Performance in ADLs (ADAPT test) Daily activity Results of outcome measures of interest with statistical significance (p<.05) in favor of the MPK Fastest possible walking speed on 75m level ground increased 14.4% (p=0.01)*. Walking speed on 38m uneven terrain increased 19.9% (p=0.008)* Stair descent improved 62.8% (p=0.04)*. Stair descent (Stair Assessment index) improved 273% (p=0.008). Hill descent (Hill Assessment Index) improved 38.9% (p=0.008). Downhill walking speed increased 29.4% (p=0.002). Obstacle course walking speed increased 11.3% (p=0.02). Attention walking speed increased 12% (p=0.02) Performance time in standing activities requiring adequate balance (AS1) decreased with C-Leg and C-Leg Compact in the total group (p=0.0001 and p=0.002), in high MFCL-2 (p=0.01 and p=0.019) and in intermediate MFCL-2 (p=0.004 and p=0.008). Performance time in activities requiring sitting down and standing up (AS2) decreased in intermediate MFCL-2 with C-leg (p=0.016). Performance time in ambulation activities heavily depending on the patient´s prosthesis related skills (AS3) decreased in high MFCL-2 with C-Leg Compact (p=0.023). none

12. | © Otto Bock HealthCare Summary of outcome measures 12 Total number of outcome measures Significant benefit of MPK No difference between MPK and NMPKs Significant benefit of NMPKs Safety13 6 (46%) +trend in 2 (15%) 5 (39%) 0 Performance- based function and mobility 51 28 (55%) 22 (43%) 1 (2%) Biomechanical parameters 40 18 (45%) 22 (55%) 0 Self-reported function and mobility outcomes 96 22 (23%) 74 (77%) 0 Kannenberg A, Zacharias B, Pröbsting E: Benefits of microprocessor prosthetic knees to limited community ambulators: A systematic review. J Rehabil Res Dev 2014; 51 (10): 1469-1495.

13. | © Otto Bock HealthCare Discussion 13 Based on the walking speed or AMP scores of the patients on their NMPK prosthesis in the reviewed studies, the following statements can be made:  Individuals walking slower than.5 m/s have not yet been studied using MPKs.  Individuals walking between.5 and.75 m/s may benefit from using an MP stance control knee in safety and activities required for community ambulation such as walking slopes, uneven terrain, and stairs.  Individuals walking faster than.75 m/s may benefit from using an MP stance and swing control knee in safety and activities of community AND multidirectional indoor ambulation. Kannenberg A, Zacharias B, Pröbsting E: Benefits of microprocessor prosthetic knees to limited community ambulators: A systematic review. J Rehabil Res Dev 2014; 51 (10): 1469-1495.

14. | © Otto Bock HealthCare Safety and function of MP stance and swing controlled prosthetic knees 14 Safety reduced stumbles and falls reduced indicators for risk of falling improved balance improved confidence Function and mobility improved ability to perform activities of community ambulation improved ability to perform ADLs important to independence improved satisfaction >90% of amputees prefer an MPK +

15. | © Otto Bock HealthCare Non-MP and MP controlled hydraulic ankles 15

16. | © Otto Bock HealthCare Hydraulic and MP-controlled ankles 16 + Evidence Safety Increase in minimal toe clearance and reduction of the risk of tripping over an unseen obstacle in below-knee amputees Socket residual limb interface Reduction of soft tissue loading and pressure during walking, especially while walking on slopes, uneven terrain, and stairs Level walking Reduction of braking forces during level walking, reduction of the perception to have to “climb over the foot” at loading response, significant increase in self-selected walking speed in both below- and above-knee amputees Slope and stair ambulation More symmetrical and physiological movement patterns with reduction of compensatory movements and loading of the sound side in below-knee amputees

17. | © Otto Bock HealthCare 17 I © Otto Bock HealthCare Orthotics SCO Locked KAFO Posterior off-set KAFO C-Brace

18. | © Otto Bock HealthCare 18 Paresis of Knee Stabilizing Muscles A paresis of the muscles stabilizing the knee may be caused by various diseases or injuries (e.g. polio, post-polio, lumbar disc herniation, injury to the femoral nerve, spinal cord injury, stroke). I © Otto Bock HealthCare

19. | © Otto Bock HealthCare 19 KAFO technologies Locked KAFO locked (stiff) knee joint during stance and swing Posterior off-set KAFO knee locked during stance due to GRF acting anterior of the knee, free swing Stance Control Orthoses (SCO) locked knee (fully extended or slightly flexed) during stance, free swing All standard KAFO/SCO technologies do not allow for  stance yielding  knee flexion during weight bearing (required for alternate ramp and stair descent) I © Otto Bock HealthCare

20. | © Otto Bock HealthCare 20 Orthotic technologies Locked KAFOStance Control Orthosis I © Otto Bock HealthCare

21. | © Otto Bock HealthCare foot part C-Leg® hydraulic unit orthotic knee unit w/ knee angle sensor AFO with carbon fibre strut and integrated ankle moment sensor (intelligent AFO) 21 Orthotronic Walking Device: C-Brace® …allows for stance yielding and knee flexion during weight bearing as known from MP stance controlled prosthetics, allowing for reciprocal ramp and stair descent. I © Otto Bock HealthCare

22. | © Otto Bock HealthCare 22 Results: Level walking kinematics Stance knee flexion  only relative movement between limb and orthosis with SCO/LKAFO  nearly physiologic knee stance flexion in 4/6 pts. with C-Brace (11° ± 5.6°) Swing knee flexion  SCO: undampened knee flexion higher than normal (74° ± 6.4° compared to 65° [normal]  C-Brace: close to normal (66° ± 8.5°) C-Brace SCO able-bodied subjects Schmalz T, Bellmann M, Pröbsting E, Blumentritt S: A functional comparison of conventional KAFOs and a microprocessor-controlled leg orthosis system based on biomechanical parameters. Prosthet Orthot Int, published online 23 September 2014, DOI: 10.1177/0309364614546524

23. | © Otto Bock HealthCare 23 I © Otto Bock HealthCare

24. | © Otto Bock HealthCare 24 Questionnaires used for the survey Challenge There are no validated outcome measures for KAFO/SCO fitting and use. Therefore, outcome measures had to be developed:  Orthosis Evaluation Questionnaire (OEQ) based on the validated Prosthesis Evaluation Questionnaire (PEQ): 81 questions to be answered on a Visual Analague Scale (VAS), resulting in a total score and 9 sub-scores I © Otto Bock HealthCare

25. | © Otto Bock HealthCare 25 Orthosis Evaluation Questionnaire (OEQ) p=.02 I © Otto Bock HealthCare 68.9 ± 10.781.0 ± 6.7

26. | © Otto Bock HealthCare I © Otto Bock HealthCare 26 OEQ subdomains with significant benefits of C-Brace® 63.5±20.6 vs. 85.1±12.3 72.9±20.2 vs. 88.5±11.0 61.7±28.1 vs. 81.3±17.1 49.1±33.3 vs. 86.9±23.7 p=.003 p=.02 p=.008

27. | © Otto Bock HealthCare I © Otto Bock HealthCare 27 OEQ subdomains with insignificant benefits of C-Brace® 71.6±115 vs. 72.6±18.5 70.7±35.1 vs. 80.3±22.9 83.6±20.5 vs. 86.4±15.2 66.6±27.5 vs. 70.4±33.2

28. | © Otto Bock HealthCare I © Otto Bock HealthCare 28 OEQ subdomains with insignificant benefits of KAFO/SCO 83.4±16.578.4±18.1

29. | © Otto Bock HealthCare 29 Conclusions The differences in technology between standard KAFOs/SCOs and the MP controlled orthotronic walking device result in improved perceived orthotic function and ease of performing many activities of daily living that patients consider important for their everyday lives. These improvements may create a good basis for further improvement of participation in familiy, social, and professional life. I © Otto Bock HealthCare

30. Thank you andreas.kannenberg@ottobock.com for your attention.