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TRANSCRIPT
Evidence for the Benefits of
Microprocessor Controlled Prosthetic Knees
Andreas Kannenberg, MD PhD, Executive Medical Director North America
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 2
Passive microprocessor-controlled prosthetic knees
Genium / X3 C-Leg (4) / C-Leg Compact
(Ottobock, Germany)
Rheo Knee(Össur, Iceland)
Orion (Endolite, UK)
Plié (Freedom
Innovations, USA)
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 3
Different principles of the passive MPKs (1)
Default stance• Genium / X3• C-Leg / C-Leg Compact• Kenevo• Orion• Plié
Default swing• Rheo Knee
Always in stance resistance, unless switched into swing.
Always in swing resistance, unless switched into stance.
1Lusardi M.M., Jorge, M., Nielsen C. (2012) Orthotics and prosthetics in rehabilitation 3rd Edition. Elsevier Health Sciences.
“Whether a stumble or fall will result from an unexpected step onto a flexed knee depends greatly on the MPK default setting. MPKs with swing phase knee resistance default settings require great compensatory movements; otherwise, falls occur even in younger people whose amputation etiologies were nondysvascular.”1
“Whether a stumble or fall will result from an unexpected step onto a flexed knee depends greatly on the MPK default setting. MPKs with swing phase knee resistance default settings require great compensatory movements; otherwise, falls occur even in younger people whose amputation etiologies were nondysvascular.”1
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 4
Different principles of the passive MPKs (2)
Separate simultaneous control of flexion and extension resistance• Genium / X3• C-Leg / C-Leg Compact• Kenevo• Orion
One resistance only for both flexion and extension at a time• Rheo Knee• Plié
High stance flexion resistance for stumble recovery during low extension resistance for swing.
Needs to switch into stance first in case of a stumble to provide high flexion resistance.
!!! SAFETY !!!
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 5
Different principles of the MPKs (3)
MP stance and swing control• Genium / X3• C-Leg• Rheo Knee• Orion
MP stance control• C-Leg Compact• Kenevo
MP switch, but non-MP stance and swing control• Plié
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 6
English language publications on different MPKs
0
10
20
30
40
50
60
C-Leg / C-Leg Compact Genium/X2 Rheo Knee Orion Plié
49
10
51 1
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 7
Safety of the C-Leg:
Wetz HH et al., Orthopäde 2005, 34: 298-319Johansson JL et al., Am J Phys Med Rehabil 2005, 84: 563-575Chin T et al., POI 2006, 30(1): 73-80Segal AD et al., JRRD 2006, 43: 857-870Hafner BJ et al., Arch Phys Med Rehabil 2007, 88: 207-217Kaufman KR et al., Gait & Posture 2007, 26: 489-493Schmalz T et al., Gait & Posture 2007, 25: 267-278Kahle JT et al., JRRD 2008, 45: 1-14Drerup B et al., Orthopädie-Technik 2008, 3: 169-174Blumentritt S et al., J Prosthet Orthot 2009, 21 (1): 2-15Hafner BJ et al., JRRD 2009, 46 (3): 417-434Bellmann M et al., Arch Phys Med Rehabil 2010, 91 (4): 644-652Blumentritt, S et al., Orthopädie-Technik 2010, 11: 788-799Highsmith MJ et al., Prosthet Orthot Int 2010, 34 (4): 362-377
Less stumbles and falls, improved balance
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 8
Systematic Review of C-leg Research
18 studies comparing the C-leg to mechanical prosthetic knees were reviewed
7 studies on safety
8 studies on energy efficiency
3 studies on cost-effectiveness (Sweden, Italy, Netherlands)
methodologic quality of the safety and energy efficiency studies was rated low to moderate
methodological quality of the cost-effectiveness studies was rated high
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. Prosth Orthot Int 2010, 34 (4): 362-377
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 9
Safety – Summary of the 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. Prosth Orthot Int 2010, 34 (4): 362-377
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 10
Blumentritt S et al., 2009
Blumentritt S, Schmalz T, Jarasch R: The safety of C-leg: Biomechanical Tests. JPO 2009, 21 (1): 2-15
Study design
Biomechanical study comparing the safety of the C-leg, 3R80, and Mauch SNS (3C1) in repeated challenges in three experienced TF amputees (2 K4, 1 K3)
Tested challenges:
sudden stop on the prosthetic side
sidestepping on the prosthetic side
stepping onto an obstacle (under the heel, midfoot, forefoot)
tripping (interruption of knee extension during terminal swing)
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 11
Sudden stop on the prosthetic leg
Sudden stop on the prosthetic side
Sudden stop on the prosthetic side
with step to the side
safe C-leg safe
safe Hybrid safe
compensatory movements Rheo compensatory movements
incidental knee collapse Adaptive incidental knee collapse
Bellmann M, Schmalz T, Blumentritt S: Comparative biomechanical analysis of current microprocessor controlled prosthetic knee joints. Arch Phys Med Rehabil 2010, 91: 644-652.
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 12
Sudden stop on the prosthetic leg (C-Leg)
Courtesy Micheal Leach, Otto Bock USA
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 13
Tripping…
Bellmann M, Schmalz T, Blumentritt S: Comparative biomechanical analysis of current microprocessor controlled prosthetic knee joints. Arch Phys Med Rehabil 2010, 91: 644-652.
…caused by a rapid tug on a thin cord attached to the prosthetic foot to interrupt swing extension at different knee angles.
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 14
Tripping
Bellmann M, Schmalz T, Blumentritt S: Comparative biomechanical analysis of current microprocessor controlled prosthetic knee joints. Arch Phys Med Rehabil 2010, 91: 644-652.
Hybrid Knee C-leg
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 15
Tripping at different knee angles
Bellmann M, Schmalz T, Blumentritt S: Comparative biomechanical analysis of current microprocessor controlled prosthetic knee joints. Arch Phys Med Rehabil 2010, 91: 644-652.
• no problems
• heavy compensation
• fall
Zug Kontakt Prob. Zug Kontakt Prob. Zug Kontakt Prob. Zug Kontakt Prob.
[°] [°] # [°] [°] # [°] [°] # [°] [°] #
13 0 7 15 11 6 15 9 415 10 516 10 716 13 5
20 9 6 18 8 8
24 10 2 29 10 2 21 16 4 21 17 7
26 4 3 23 11 1 26 15 128 4 3 25 20 3 27 25 8
28 19 831 12 8 31 22 3 30 20 4 30 25 4
33 9 1 31 22 5 32 28 2 34 19 433 19 3 33 25 435 14 1 34 28 6
36 18 5 36 25 8 38 26 739 29 4 36 30 842 27 4 37 17 443 14 2 39 36 6
45 34 8 40 25 148 26 6 47 15 7 42 40 2 43 37 749 27 1 48 30 1 44 33 7 45 37 749 29 7 50 25 8 45 35 3 45 37 850 34 7 52 37 6 48 20 1 52 32 1
53 26 1 54 26 8 50 33 7
Adaptive2
10
° - 20
°
Knieflexionswinkel bei Störung
C-Leg Synergy Rheo
21
° - 35
°3
5° - 5
5°
knee flexion angle at pertubation Maximum “knee pertubation angle“ that can be compensated by the different MP knees:
C-leg 35°
Rheo 30°Hybrid 30°
Adaptive 20°Mauch SNS/Ca-Tech 20°
other mechanical knees 10°
C-leg Hybrid Rheo Adaptive
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012
Safety outcomes in the K2 population
16
Study Kahle 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 none none
*post-hoc statistical analysis of published raw data using the Wilcoxon signed rank test
Kannenberg A, et al.: Benefits of MPKs in limited community ambulators: A systematic review of the literature. JRRD 2015; 51(10): 1469-1496.
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 17
non-MPK C-leg
Courtesy of Michael Leach, CPO,Ottobock
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012
Which clinical benefits can be supported by evidence?
improved safety – less stumbles and falls (up to 80%!), improved balance and confidence (Kannenberg et al. 2014, Highsmith 2014, Burnfield et al. 2012, Highsmith et al. 2010,
Blumentritt et al. 2009, Hafner et al. 2009 and 2007, Kahle et al. 2008, Kaufman et al. 2007)
18
C-Leg/Compact vs. non-MPK´s
improved and faster slope negotiation (Kannenberg et al. 2014, Highsmith et al. 2013, Burnfield
et al. 2012, Hafner et al. 2009 and 2007)
improved and faster negotiation of uneven terrain and obstacles (Kannenberg et
al. 2014, Hafner et al. 2009 and 2007, Kahle et al. 2008, Seymour et al. 2007)
improved stair descent (Kannenberg et al. 2014, Hafner et al. 2009 and 2007, Kahle et al. 2008,
Schmalz et al. 2007 and 2002)
reduced cognitive demand to walk and improved multi-tasking (Morgan et al. 2015,
Kannenberg et al. 2014, Hafner et al. 2009, Williams et al. 2006)
potential to increase overall mobility / K-level (Kannenberg et al. 2014, Hafner et al. 2009,
Kahle et al. 2008)
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012
Which clinical benefits can be supported by evidence?
19
C-Leg/Compact vs. non-MPK´s in K2 patients
Up to 80% reduction in falls, reduced risk of falling, improved balance confidence
14-25% faster walking speed on level ground
20% faster walking speed on uneven terrain
30% faster slope descent, improved quality of stair descent
improved performance in activities of community ambulation – about 50% of K2 improved mobility level to K3
improved indoor ADL performance
(Kannenberg et al. 2014, Eberly et al. 2013, Burnfield et al. 2012, Theeven et al. 2012 and 2011, Hafner et al. 2009, Kahle et al. 2008)
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 20
Courtesy of Dale Berry, CPO, Hanger Clinic
Improved slope ambulation and reduced cognitive load
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 21
Improved stair ambulation and multi-tasking
Courtesy of Dale Berry, CPO, Hanger Clinic
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012
The Genium Bionic Prosthetic Knee:A Further Advancement of MPKs
Andreas Kannenberg, MD PhD, Executive Medical Director North America
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 23
Clinical study Genium v. C-Leg v. able-bodied subjects
Objectiveto compare Genium and C-Leg in K3 unilateral TF amputees in terms of: function safety quality of life
Study population
20 amputees (16 males, 4 females, age 46.5 ± 14.2 yrs)
• unilateral MFCL-3 TF or knee disarticulation• experience with the C-Leg for at least 1 year
5 able-bodied subjects as physiologic controls
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 24
Enrolled patients Randomization
C-Leg
C-LegGenium
Genium
C-Leg
C-Leg
C-Leg
60 days
2 weeks
acclimation: 67.9+27.1 days
acclimation: 67.9+27.1 days
2 weeks
Study design Genium v. C-leg
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 25
Highsmith MJ, Kahle JT, Miro RM, Lura DJ, Dubey RV, Carey SL, Quillen WS, Megelkoch LJ: Perceived differencesbetween the Genium and the C-Leg microprocessor prosthetic knees in prosthetic-related function and quality oflife. Techn Innov 2014, 15: 369-375
Outcome measures
Genium v. C-Leg
Prosthesis Evaluation Questionnaire (PEQ) and its subdomains Ambulation Utility Well-Being Perceived response Sounds Residual limb health Social burden Frustration Appearance
measure perceived prosthetic function and prosthesis-related quality of life using an ordinal scaling (0-7).
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 26
Highsmith MJ, Kahle JT, Miro RM, Lura DJ, Dubey RV, Carey SL, Quillen WS, Megelkoch LJ: Perceived differencesbetween the Genium and the C-Leg microprocessor prosthetic knees in prosthetic-related function and quality oflife. Techn Innov 2014, 15: 369-375
Results: PEQ (*p≤ .05)
Genium
C-Leg
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 27
Results: PEQ
Histograms
0
10
20
30
40
50
60
0 1 2 3 4 5 6 7
Residual limb health
C-Leg
Genium
0
10
20
30
40
50
60
70
0 1 2 3 4 5 6 7
Utility
0
5
10
15
20
25
30
35
40
0 1 2 3 4 5 6 7
Social burden
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 28
Highsmith MJ, Kahle JT, Miro RM, Lura DJ, Dubey RV, Carey SL, Quillen WS, Megelkoch LJ: Perceived differencesbetween the Genium and the C-Leg microprocessor prosthetic knees in prosthetic-related function and quality oflife. Techn Innov 2014, 15: 369-375
Results: Individual PEQ items and aggregate score
Aggregate PEQ score (items of all subdomains) is significantly higherwhen using Genium (p<.001).
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 29
10 ADLs• Carry a weighted pot a distance of 1 m• Donning and removing a jacket • Place and remove a sponge from an
adjustable shelf• Floor sweeping with broom and dustpan• Pick up four scarves from the floor• Sit and stand up from the floor• Carry groceries• Stair climbing• Moving laundry from washer to dryer• 6 minute walk test
PFP-10 Subdomains
• Upper body strength
• Upper body flexibility
• Lower body strength
• Balance and Coordination
• Endurance
SOFTWARE
Physical Functional Performance Measure (PFP-10)
Highsmith MJ: Comparative outcomes of the C-leg and X2 prosthetic knees prosthesis. Dissertation, University of South Florida, Tampa, December 2012, publications in preparation
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 30
+ Genium vs C-Leg (p<0.05)
++ C-Leg vscontrol (p<0.05)
C-Leg
Genium
Controls
Results: PFP-10 subdomains
Highsmith MJ, Kahle JT, Miro RM, Cress ME, Lura DJ, Dubey RV, Carey SL, Quillen WS, Megelkoch LJ: Effects of the Genium Knee in Persons with Transfemoral Amputation using the Continuous Scale Physical Functional Performance-10 (CS-PFP10) Assessment. Accepted by J Rehabil Res Dev, in press.
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 31
Results: PFP-10 subdomain summary
Highsmith MJ, Kahle JT, Miro RM, Cress ME, Lura DJ, Dubey RV, Carey SL, Quillen WS, Megelkoch LJ: Effects of the Genium Knee in Persons with Transfemoral Amputation using the Continuous Scale Physical Functional Performance-10 (CS-PFP10) Assessment. Accepted by J Rehabil Res Dev, in press.
Able-bodied subjects v. amputees with Genium
significantly higher score only in the endurance domain (p=.05)
no differences in the CS-PFP total score and the other 4 domains
Able-bodied subjects v. amputees with C-Leg
Significantly higher scores in the CS-PFP total score and 4/5 domains,
except upper body strength
Genium v. C-Leg
Significantly higher CS-PFP total score (p=.03)
Significantly higher scores in 3/5 domains (upper body flexibility, balance,
endurance), except upper body strength and lower body strength
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 32
Study design
14 wounded servicemembers with a unilateral transfemoral amputationwere studied for
- the self-sected strategy to ascend stairs (Stair Assessment Index [SAI])
- gait biomechanics during walking upstairs
when using the Ottobock X2® MP controlled prosthetic knee (meanacclimation 130 ± 41 days) as compared to the C-Leg (12 pts.) or theTotal Knee (2 pts.).
I © Otto Bock HealthCareAldridge Whitehead JM, Wolf EJ, Scoville CR, Wilken JM: Does a microprocessor-controlled prosthetic knee affect stair ascent strategies in persons with transfemoral amputations? Clin Orthop Rel Res 2014 Feb 11 [epub ahead of print].
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 33
Stair Assessment Index (SAI)
I © Otto Bock HealthCare
Score Mobility Descriptor
0 Cannot do/ refuses to do
1 Needs assist
2 With rail and assistive device, step-to pattern
3 With rail, step-to pattern
4 With assistive device, step-to pattern
5 Without rail or assistive device, step-to pattern
6 With rail and assistive device, skipping step pattern
7 With rail, skipping step pattern
8 With assistive device, skipping step pattern
9 Without rail or assistive device, skipping step pattern
10 With rail and assistive device, step-over-step pattern
11 With rail, step-over-step pattern
12 With assistive device, step-over-step pattern
13 Without rail or assistive device, step-over-step pattern
Hafner BJ, Willingham LL, Buell NC, Allyn KJ, Smith DG: Evaluation of Function, Performance, and Preference as Transfemoral Amputees Transition from Mechanical to Microprocessor Control of the Prosthetic Knee. Arch Phys Med Rehabil 2007; 88: 207-217
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 34
Results
Self-selected stair ascend strategy
I © Otto Bock HealthCareAldridge Whitehead JM, Wolf EJ, Scoville CR, Wilken JM: Does a microprocessor-controlled prosthetic knee affect stair ascent strategies in persons with transfemoral amputations? Clin Orthop Rel Res 2014 Feb 11 [epub ahead of print].
step-over-
step (A)
step-to
(B)
skip-step
(C)
X2 10 2 2
C-Leg /
NMPK
1 10 3
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 35
Results
Stair Assessment Index (SAI) - medians
X2 11 (step-over-step with handrail use)
C-Leg 5 (step-to without handrail use)
Significantly improved quality of stair ascend (p=.005).
I © Otto Bock HealthCareAldridge Whitehead JM, Wolf EJ, Scoville CR, Wilken JM: Does a microprocessor-controlled prosthetic knee affect stair ascent strategies in persons with transfemoral amputations? Clin Orthop Rel Res 2014 Feb 11 [epub ahead of print].
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012
Which clinical benefits can be supported by evidence?
improved and more consistent, speed-independent toe clearance due to improved
swing knee flexion control (Bellmann et al. 2012, Lura et al. 2015)
36
Genium/X3 vs. “standard“ MPK´s (e. g. C-Leg)
improved swing release and toe clearance in small steps (Bellmann et al. 2012)
safe walking backwards (Kannenberg et al. 2013)
improved knee flexion and thus toe clearance in slope ascent and descent (Bellmann et
al. 212, Lura et al. 2015), greater perceived ease of slope negotiation (Kannenberg et al. 2013)
tendency to greater ease of uneven terrain negotiation (Highsmith et al. 2014, Kannenberg et al.
2013)
70-80% of subjects adopt reciprocal stair ascent (Aldridge Whitehead et al. 2014, Highsmith et al.
2014, Schmalz et al. 2014, Bellmann et al. 2012), greater ease of stair ascent and descent
(Kannenberg et al. 2013)
Greater perceived safety and ease of ADL execution (Kannenberg et al. 2013) and improved
prosthetic function (Highsmith et al. 2014)
improved ability to stand still for longer periods of time (Bellmann et al. 2012)
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 37
Genium/X3: Stair climbing
| © Otto Bock HealthCareAndreas Kannenberg – Baltimore, MD - March 28, 2012 38
Genium/X3: Stepping over obstacles
Stepping over obstacles with the prosthesis (left leg)