Clinical Evidence Finder – Lower Limb Prosthetics

AvalonK2

Improvements in Clinical Outcomes using Avalon compared to non-hydraulic feet

• Mobility

  Improved gait performance

  • Faster self-selected walking speed¹
  • Smoother centre-of-pressure progression¹

  Keel and ankle designed for Activities of Daily Living

  • Easier sit-to-stand²
• Loading symmetry
  • Mean 34% reduction in stance phase timing asymmetry³
  • Maximum 86% reduction in stance phase timing asymmetry³
  • More symmetrical inter-limb loading¹
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains⁴

Clinical Outcomes using the Avalon/Navigator keel design

• Mobility
  • Shorter keel allows for more consistent rollover radius of curvature, regardless of changing footwear⁵
  • The most energy efficient radius of curvature for a rollover shape has been identified as 30% of the walker’s leg length. For a person of a typical adult height between 1.5m and 1.8m, this equates to approximately 245-290mm. The Avalon keel design has a rollover shape of ~250mm⁵

AvalonK2VAC

Improvements in Clinical Outcomes using Avalon compared to non-hydraulic feet

• Mobility

  Improved gait performance

  • Faster self-selected walking speed¹
  • Smoother centre-of-pressure progression¹

  Keel and ankle designed for Activities of Daily Living

  • Easier sit-to-stand²
• Loading symmetry
  • Mean 34% reduction in stance phase timing asymmetry³
  • Maximum 86% reduction in stance phase timing asymmetry³
  • More symmetrical inter-limb loading¹
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains⁴

Improvements in Clinical Outcomes using Avalon compared to non-hydraulic feet

• Safety

  Fewer falls and less chance of multiple falls

  • No trans-tibial EVS users reported multiple falls, while 75% of the non-EVS users did⁵

  Better balance in functional clinical tests

  • Significant improvements in the Berg Balance Scale (BBS), the Four Square Step Test (FSST) and the Timed-Up-and-Go (TUG) test⁶

  Better balance reported in patient-reported outcome measures

  • Improvements in the Activity Balance Confidence (ABC) scale questionnaire⁷
• Mobility
  • Fewer gait compensations^8-10
  • Knee contact forces not significantly different to those of able-bodied controls¹¹
• Suspension

  Decreased pistoning

  • Reductions of over 69% and 83%, compared to suction^10,12 and pin-lock¹³ suspensions, respectively, with other researchers and practitioners reporting similar observations^7,8,14,15

  Maintain residual limb volume

  • Suction suspension = mean 6.5% loss in volume; EVS = mean 3.7% increase in volume (N.B. it is possible that the increase may have been due to the fact that these individuals attended the clinic wearing their regular prostheses before using the EVS system).¹⁰
  • Other studies have since confirmed the observation that residuum volume loss is prevented by EVS^8,16-19
• Residual Limb Health

  Healthier residual limb tissue and skin

  • Higher trans-cutaneous oxygen measurement after activity²⁰
  • Decreased trans-epidermal water loss after activity²⁰
  • Decreased attenuated reactive hyperemia²⁰

  Reduced interface pressures

  • Pressures reduced by a mean of 4% compared to suction suspension²¹
  • Pressure impulses reduced by a mean of 7.5% compared to suction suspension²¹

  Improved wound management

  • Continued prosthesis use while the wounds healed^22-24
  • Wounds heal more quickly with EVS than other suspension methods²⁵

  Less painful than other suspension methods

  • Expert opinion⁸ and clinical case studies²⁶ agree that EVS is less painful and more comfortable than other suspension methods.
  • Improved Socket Comfort Score compared to other suspension methods⁵
• User satisfaction
  • Patients are more satisfied wearing their prosthesis^{5,7,8,15,23,26-28}

Clinical Outcomes using the Avalon/Navigator keel design

• Mobility
  • Shorter keel allows for more consistent rollover radius of curvature, regardless of changing footwear²⁹
  • The most energy efficient radius of curvature for a rollover shape has been identified as 30% of the walker’s leg length. For a person of a typical adult height between 1.5m and 1.8m, this equates to approximately 245-290mm. The Avalon keel design has a rollover shape of ~250mm²⁹

Other Evidence

• Other Internal unpublished Blatchford research

  Vacuum levels generated:

  When sensory control of the lower limb joints is lost, it is essential that the replacement behaves predictably. Consistency of performance is vital in providing prosthetic confidence. In terms of socket suspension method, this means providing the same good connection throughout a gait cycle, from one step to the next, and day-to-day, over the lifetime of the socket.

  The difference between the vacuum levels generated by suction suspension, and that generated when using EVS, can be demonstrated by using a negative pressure gauge³⁰. Figure 1 illustrates these measurements. Commonly, when the user bears weight on their prosthesis during stance phase, with suction suspension, the magnitude of the vacuum is low. When the leg is lifted into swing phase, the vacuum increases in magnitude, holding the socket to the residual limb. Comparatively, EVS retains a high level during stance phase – higher, in fact, than the peak swing phase vacuum with suction. Additionally, the difference between stance and swing phase is less pronounced, so that the vacuum level is more consistent throughout the gait cycle. For the amputee illustrated in the graph³⁰, EVS gave an approximate 85% increase in peak vacuum magnitude and an approximate 67% reduction in the ‘amplitude’ of the vacuum measurement signal.

  

  Figure 1: Negative pressure within the socket when walking using a one-way valve suction suspension (grey) and an elevated vacuum (EV) suspension. N.B. Data recorded with Echelon Vac system.

  The difference in vacuum generated by the AvalonVAC, compared to that generated by the Echelon Vac, is shown in Figure 2. Despite differences in the method used (keel vs springs, different socket, different pressure gauge), when the same patient was asked to walk at ‘K2 walking speed’ (~2km/h, short steps), the trend of vacuum level to number of steps taken was comparable to when measured at ‘K3 walking speed’ (4-5km/h) with Echelon Vac.

  

  Figure 2: Comparison of the EchelonVAC and AvalonVAC vacuum generation by number of steps

BladeXT

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Child’s 4-Bar Knee

Improvements in Clinical Outcomes using four-bar, polycentric knees compared to monoaxial knees

• Safety
  • Increased mean prosthetic minimum toe clearance^2,4, reducing the likelihood of tripping.
  • Fully satisfies stance phase stability³
• User satisfaction
  • Acceptable cosmetics for knee disarticulation amputees and trans-femoral amputees with long residua¹
  • Meets all the design requirements for paediatric patients³

Comfort Liner

• Clinical Evidence Overview

  There are two published literature reviews that discuss different aspects of lower limb prosthetic liner technology^1,2.

  • The main purpose of prosthetic liners is to cushion the transfer of loads from the prosthetic socket to the residual limb¹.
  • Based on load-displacement data from the compressive stiffness tests, silicone was one of three materials that were recommended for situations where it is desirable for the liner to maintain thickness and volume since these materials had the least non-recovered strain^1,3.
  • Under cyclic compressive loading, silicone was one of two materials that had the greatest cycles to failure under compressive loading, while the Pedilin and polyurethane samples lasted orders of magnitude less^1,4.
  • Prosthetic liners and sockets are highly resistive to heat conduction and could be a major contributor to elevated skin temperatures^1,5.
  • There are reduced residual limb pressures with the silicone liner compared to other conditions (no liner; soft inserts) suggesting that silicone has an ability to distribute pressure evenly to the residual limb^1,6.
  • In terms of patient outcomes, there was no clear preference between silicone and Pelite liners^1,7.

Echelon

Improvements in Clinical Outcomes using Echelon compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^1,2

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)³
• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds⁴
  • Mean 20.2% reduction in energy use on slopes, across all gradients⁴
  • Mean 8.3% faster walking speed for the same amount of effort⁴
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^2,5-7
  • Higher PLUS-M scores than FlexFoot and FlexWalk style feet⁸

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking⁹
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking⁹

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement⁵
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance⁵
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase⁵
  • Reduced peak negative COP velocity⁷
  • Reduced COP posterior travel distance⁷

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent¹⁰
  • Increased dorsiflexion range during slope ascent¹⁰
• Residual Limb Health

  Helps protect vulnerable limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb¹¹
  • Reduced stress RMS on residual limb¹¹
  • Reduced loading rates on residual limb¹¹
• Loading symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee negative work⁶

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment⁶
  • Reduced intact limb peak dorsiflexion moment⁶
  • Reduced intact ankle negative work and total work⁶
  • Reduced intact limb total joint work⁶

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees³

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments¹²

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure¹³

  Improved gait symmetry

  • Reduced stance phase timing asymmetry¹⁴
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains¹⁵
  • Bilateral patients showed highest mean improvement in satisfaction¹⁵

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle¹³

EchelonVAC

Improvements in Clinical Outcomes using Echelon compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^1,2

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)³
• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds⁴
  • Mean 20.2% reduction in energy use on slopes, across all gradients⁴
  • Mean 8.3% faster walking speed for the same amount of effort⁴
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^2,5-7
  • Higher PLUS-M scores than FlexFoot and FlexWalk style feet⁸

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking⁹
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking⁹

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement⁵
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance⁵
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase⁵
  • Reduced peak negative COP velocity⁷
  • Reduced COP posterior travel distance⁷

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent¹⁰
  • Increased dorsiflexion range during slope ascent¹⁰
• Residual Limb Health

  Helps protect vulnerable limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb¹¹
  • Reduced stress RMS on residual limb¹¹
  • Reduced loading rates on residual limb¹¹
• Loading symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee negative work⁶

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment⁶
  • Reduced intact limb peak dorsiflexion moment⁶
  • Reduced intact ankle negative work and total work⁶
  • Reduced intact limb total joint work⁶

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees³

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments¹²

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure¹³

  Improved gait symmetry

  • Reduced stance phase timing asymmetry¹⁴
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains¹⁵
  • Bilateral patients showed highest mean improvement in satisfaction¹⁵

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle¹³

Improvements in Clinical Outcomes using EVS compared to other suspension types

• Safety

  Fewer falls and less chance of multiple falls

  • No trans-tibial EVS users reported multiple falls, while 75% of the non-EV users did¹⁶

  Better balance in functional clinical tests

  • Significant improvements in the Berg Balance Scale (BBS), the Four Square Step Test (FSST) and the Timed-Up-and-Go (TUG) test¹⁷

  Better balance reported in patient-reported outcome measures

  • Improvements in the Activity Balance Confidence (ABC) scale questionnaire¹⁸
• Mobility

  Fewer gait compensations^19-21

  Knee contact forces not significantly different to those of able-bodied controls²²

• Suspension

  Decreased pistoning

  • Reductions of over 69% and 83%, compared to suction^21,23 and pin-lock²⁴ suspensions, respectively, with other researchers and practitioners reporting similar observations^18,19,25,26

  Maintain residual limb volume

  • Suction suspension = mean 6.5% loss in volume; EVS = mean 3.7% increase in volume (N.B. it is possible that the increase may have been due to the fact that these individuals attended the clinic wearing their regular prostheses before using the EVS system)²¹
  • Other studies have since confirmed the observation that residuum volume loss is prevented by EVS^19,27-30
• Residual Limb Health

  Healthier residual limb tissue and skin

  • Higher trans-cutaneous oxygen measurement after activity³¹
  • Decreased trans-epidermal water loss after activity³¹
  • Decreased attenuated reactive hyperemia³¹

  Reduced interface pressures

  • Pressures reduced by a mean of 4% compared to suction suspension³²
  • Pressure impulses reduced by a mean of 7.5% compared to suction suspension³²

  Improved wound management

  • Continued prosthesis use while the wounds healed^33-35
  • Wounds heal more quickly with EVS than other suspension methods³⁶

  Less painful than other suspension methods

  • Expert opinion¹⁹ and clinical case studies³⁷ agree that EVS is less painful and more comfortable than other suspension methods.
  • Improved Socket Comfort Score compared to other suspension methods³⁸
• User satisfaction

  Patients are more satisfied wearing their prosthesis^{18,19,26,34,37-38}.

EchelonVT

Improvements in Clinical Outcomes using Echelon compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^1,2

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)³
• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds⁴
  • Mean 20.2% reduction in energy use on slopes, across all gradients⁴
  • Mean 8.3% faster walking speed for the same amount of effort⁴
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^2,5-7
  • Higher PLUS-M scores than FlexFoot and FlexWalk style feet⁸

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking⁹
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking⁹

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement⁵
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance⁵
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase⁵
  • Reduced peak negative COP velocity⁷
  • Reduced COP posterior travel distance⁷

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent¹⁰
  • Increased dorsiflexion range during slope ascent¹⁰
• Residual Limb Health

  Helps protect vulnerable limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb¹¹
  • Reduced stress RMS on residual limb¹¹
  • Reduced loading rates on residual limb¹¹
• Loading symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee negative work⁶

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment⁶
  • Reduced intact limb peak dorsiflexion moment⁶
  • Reduced intact ankle negative work and total work⁶
  • Reduced intact limb total joint work⁶

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees³

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments¹²

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure¹³

  Improved gait symmetry

  • Reduced stance phase timing asymmetry¹⁴
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains¹⁵
  • Bilateral patients showed highest mean improvement in satisfaction¹⁵

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle¹³

Improvements in Clinical Outcomes using shock-absorbing pylon/torque absorber compared to rigid pylon

• Safety
  • Reduced back pain during twisting movements e.g. golf swings¹⁶
• Mobility
  • Reduced compensatory knee flexion at loading response¹⁷
  • No reduction in step activity¹⁸
  • Blatchford torsion adaptors match the able-bodied rotational range¹⁹
• Residual Limb Health
  • Reduced loading rate on prosthetic limb²⁰, particularly at fast walking speeds²¹
  • Users feel less pressure on their residual limb²²
• User satisfaction
  • Patient preference, citing improved comfort, smoothness of gait and easier stairs descent²⁰

Elan

Improvements in Clinical Outcomes using Elan compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^1,2

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment³

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)4
• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds⁵
  • Mean 20.2% reduction in energy use on slopes, across all gradients⁵
  • Mean 8.3% faster walking speed for the same amount of effort⁵
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^2,6-9

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking¹⁰
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking¹⁰

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement⁷
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance⁷
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase⁷
  • Reduced peak negative COP velocity⁹
  • Reduced COP posterior travel distance⁹

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent³
  • Increased dorsiflexion range during slope ascent³

  Less effort on residual hip for trans-femoral amputees on varied terrains

  • Reduced the mean hip extension and flexion moments¹¹

  Effects consistent over time

  • Same gait variable changes in two gait lab sessions one year apart⁶
  • Magnitude of changes comparable between sessions⁶

  Brake mode during slope descent to control momentum build up

  • Reduced mean prosthetic shank angular velocity in single support¹²
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work¹²

  Less gait compensation movements during slope descent

  • Reduced residual knee flexion at loading response¹²
• Residual Limb Health

  Helps protect vulnerable limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb¹³
  • Reduced stress RMS on residual limb¹³
  • Reduced loading rates on residual limb¹³
    
• Loading symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee peak extension moment⁶
  • Decreased residual knee peak flexion moment⁶
  • Increased residual knee negative work⁸

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment⁸
  • Reduced intact limb peak dorsiflexion moment⁸
  • Reduced intact ankle negative work and total work⁸
  • Reduced intact limb total joint work⁸

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees⁴

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments¹⁴

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment¹⁴
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres¹⁴

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure¹⁵

  Improved gait symmetry

  • Reduced stance phase timing asymmetry¹⁶
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains¹⁷
  • Bilateral patients showed highest mean improvement in satisfaction¹⁷

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle¹⁵

Improvements in Clinical Outcomes using Elan compared to non-microprocessor-control hydraulic ankle-feet

• Safety

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment³
• Mobility

  Improved ground compliance when walking down slopes

  • Reduced time to foot flat¹²

  Brake mode during slope descent increases resistance to dorsiflexion to control momentum build up

  • Reduced dorsiflexion range during slope descent³
  • Reduced mean prosthetic shank angular velocity in single support¹²
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work¹²
  • Transition from dorsiflexion to plantarflexion moment occurs earlier in stance phase¹⁸
  • Increase in mean prosthetic ‘ankle’ plantarflexion moment integral¹⁸

  Assist mode during slope ascent decreases resistance to dorsiflexion to allow easier progression

  • Transition from dorsiflexion to plantarflexion moment occurs later in stance phase¹⁸
  • Decrease in mean prosthetic ‘ankle’ plantarflexion moment integral¹⁸

  Less gait compensation movements during slope descent

  • Reduced residual knee flexion at loading response¹²
• Loading symmetry

  Greater reliance on prosthetic side for bodyweight support during slope descent

  • Increased support moment integral¹⁸

  Less reliance on sound side for bodyweight support during slope descent

  • Decreased support moment integral¹⁸

  Less reliance on sound side for bodyweight support during slope ascent

  • Decreased support moment integral¹⁸

  Reduced sound joint moments during standing of a slope

  • Significant reductions in sound support moment¹⁴

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment¹⁴
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres¹⁴

ElanIC

Improvements in Clinical Outcomes using Elan compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^1,2

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment³

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)4
• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds⁵
  • Mean 20.2% reduction in energy use on slopes, across all gradients⁵
  • Mean 8.3% faster walking speed for the same amount of effort⁵
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^2,6-9

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking¹⁰
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking¹⁰

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement⁷
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance⁷
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase⁷
  • Reduced peak negative COP velocity⁹
  • Reduced COP posterior travel distance⁹

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent³
  • Increased dorsiflexion range during slope ascent³

  Less effort on residual hip for trans-femoral amputees on varied terrains

  • Reduced the mean hip extension and flexion moments¹¹

  Effects consistent over time

  • Same gait variable changes in two gait lab sessions one year apart⁶
  • Magnitude of changes comparable between sessions⁶

  Brake mode during slope descent to control momentum build up

  • Reduced mean prosthetic shank angular velocity in single support¹²
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work¹²

  Less gait compensation movements during slope descent

  • Reduced residual knee flexion at loading response¹²
• Residual Limb Health

  Helps protect vulnerable limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb¹³
  • Reduced stress RMS on residual limb¹³
  • Reduced loading rates on residual limb¹³
    
• Loading symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee peak extension moment⁶
  • Decreased residual knee peak flexion moment⁶
  • Increased residual knee negative work⁸

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment⁸
  • Reduced intact limb peak dorsiflexion moment⁸
  • Reduced intact ankle negative work and total work⁸
  • Reduced intact limb total joint work⁸

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees⁴

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments¹⁴

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment¹⁴
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres¹⁴

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure¹⁵

  Improved gait symmetry

  • Reduced stance phase timing asymmetry¹⁶
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains¹⁷
  • Bilateral patients showed highest mean improvement in satisfaction¹⁷

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle¹⁵

Improvements in Clinical Outcomes using Elan compared to non-microprocessor-control hydraulic ankle-feet

• Safety

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment³
• Mobility

  Improved ground compliance when walking down slopes

  • Reduced time to foot flat¹²

  Brake mode during slope descent increases resistance to dorsiflexion to control momentum build up

  • Reduced dorsiflexion range during slope descent³
  • Reduced mean prosthetic shank angular velocity in single support¹²
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work¹²
  • Transition from dorsiflexion to plantarflexion moment occurs earlier in stance phase¹⁸
  • Increase in mean prosthetic ‘ankle’ plantarflexion moment integral¹⁸

  Assist mode during slope ascent decreases resistance to dorsiflexion to allow easier progression

  • Transition from dorsiflexion to plantarflexion moment occurs later in stance phase¹⁸
  • Decrease in mean prosthetic ‘ankle’ plantarflexion moment integral¹⁸

  Less gait compensation movements during slope descent

  Reduced residual knee flexion at loading response¹²

• Loading symmetry

  Greater reliance on prosthetic side for bodyweight support during slope descent

  • Increased support moment integral¹⁸

  Less reliance on sound side for bodyweight support during slope descent

  • Decreased support moment integral¹⁸

  Less reliance on sound side for bodyweight support during slope ascent

  • Decreased support moment integral¹⁸

  Reduced sound joint moments during standing of a slope

  • Significant reductions in sound support moment¹⁴

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment¹⁴
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres¹⁴

Elite Blade

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Elite BladeVT

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Improvements in Clinical Outcomes using shock-absorbing pylon/torque absorber compared to rigid pylon

• Safety
  • Reduced back pain during twisting movements e.g. golf swings⁹
• Mobility
  • Reduced compensatory knee flexion at loading response¹⁰
  • No reduction in step activity¹¹
  • Blatchford torsion adaptors match the able-bodied rotational range¹²
• Residual Limb Health
  • Reduced loading rate on prosthetic limb¹³, particularly at fast walking speeds¹⁴
  • Users feel less pressure on their residual limb¹⁵
• User Satisfaction
  • Patient preference, citing improved comfort, smoothness of gait and easier stairs descent¹³

Elite2

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

EliteVT

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Improvements in Clinical Outcomes using shock-absorbing pylon/torque absorber compared to rigid pylon

• Safety
  • Reduced back pain during twisting movements e.g. golf swings⁹
• Mobility
  • Reduced compensatory knee flexion at loading response¹⁰
  • No reduction in step activity¹¹
  • Blatchford torsion adaptors match the able-bodied rotational range¹²
• Residual Limb Health
  • Reduced loading rate on prosthetic limb¹³, particularly at fast walking speeds¹⁴
  • Users feel less pressure on their residual limb¹⁵
• User Satisfaction
  • Patient preference, citing improved comfort, smoothness of gait and easier stairs descent¹³

Epirus

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Clinical Outcomes using Multiflex-style ankles

• Safety
  • Low stiffness at weight acceptance leads to early foot-flat and greater stability for lower mobility patients²²
  • No loss of stability during standing with Multiflex than fixed ankle/foot²³
  • Easier to walk on uneven ground with Multiflex than fixed ankle/foot^23,24
  • Easier to walk up a slope with Multiflex than fixed ankle/foot²³
• Mobility
  • Little to no difference in gait mechanics compared to flexible, “energy storing” prosthetic feet²⁵
  • Increased prosthetic ankle range-of-motion with Multiflex compared to fixed ankle/foot^23,24,26-28
  • Increased prosthetic ankle power with Multiflex compared to fixed ankle/foot²⁴
  • Prosthetic rollover shape closer to natural biomechanics than fixed ankle/foot²⁶
  • Users can walk longer distances and report “smoother” gait with Multiflex compared to fixed ankle/foot²⁴
  • Benefits in mobility for bilateral users^23,24,26,27
  • Mixed objective results when user group was more active than is recommended for Multiflex^29,30 so may benefit more from a similar but higher activity foot like Epirus.
• Residual Limb Health
  • Equivalent socket comfort to higher technology, energy-storing feet²⁹
• Loading Symmetry
  • Improved stance phase timing symmetry with Multiflex compared to fixed ankle/foot²⁸
  • Reduced sound limb loading with Multiflex compared to fixed ankle/foot²⁸
• User Satisfaction
  • Mixed subjective feedback around preferences when user group was more active than is recommended for Multiflex²⁵ so may benefit more from a similar but higher activity foot like Epirus.
  • Majority of users rate Multiflex as either “good” or “acceptable”³¹ and prefer Multiflex to fixed ankle/foot²⁴

Esprit

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Javelin

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

KX06

Improvements in Clinical Outcomes using four-bar, polycentric knees compared to monoaxial knees

• Safety
  • Increased mean prosthetic minimum toe clearance^2,4, reducing the likelihood of tripping.
  • Fully satisfies stance phase stability³
• User satisfaction
  • Acceptable cosmetics for knee disarticulation amputees and trans-femoral amputees with long residua¹
  • Meets all the design requirements for paediatric patients³

Linx

Improvements in Clinical Outcomes using Linx compared to mechanical knees

• Safety
  • Significantly reduced number of falls^1,2
  • Reduced centre-of-pressure fluctuations by 9-11% with standing support active when standing on sloped ground³
  • Less cognitive demand during walking, leading to reduced postural sway⁴
• Mobility
  • Increased walking speed⁵
  • Easier to walk at different speeds⁶
  • Higher scores in mobility-related patient-reported outcome measures⁷
  • More natural gait^6,8
  • Easier to walk on slopes⁶
• Energy Expenditure
  • Reduced energy expenditure compared to mechanical knees^9-13
  • Equivalent energy expenditure to other MPKs¹⁴
  • Reduced self-perceived effort^6,8
  • Energy expenditure closer to that of able-bodied control subjects¹⁵
  • Able to walk further before becoming tired⁶
• Symmetry
  • Better step length symmetry⁵
  • Reduced loading asymmetry with standing support active when standing on sloped ground³
• User satisfaction
  • Reduced fear of falling¹
  • Reduced limitations due to an emotional problem⁸
  • Preference over other prosthetic knees^1,6
  • Greater prosthetic confidence in slope descent and gait termination¹⁶
• Health Economics
  • Reductions in direct and indirect healthcare costs when using an MPK¹⁷

Improvements in Clinical Outcomes using Linx compared to ESR feet

• Safety

  Reduced risk of tripping and falls

  • Increased minimum toe clearance during swing phase^18,19

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment²⁰

  Improving standing balance on a slope

  • 24-25% reduction in mean inter-limb centre-of-pressure root mean square (COP RMS)³

   

• Energy Expenditure

  Reduced energy expenditure during walking

  • Mean 11.8% reduction in energy use on level ground, across all walking speeds²¹
  • Mean 20.2% reduction in energy use on slopes, across all gradients²¹
  • Mean 8.3% faster walking speed for the same amount of effort²¹
• Mobility

  Improved gait performance

  • Faster self-selected walking speed^18,22-25

  Improved ground compliance when walking on slopes

  • Increased plantarflexion peak during level walking, fast level walking and cambered walking²⁶
  • Increased dorsiflexion peak during level walking, fast level walking and cambered walking²⁶

  Less of a prosthetic “dead spot” during gait

  • Reduced aggregate negative COP displacement²³
  • Centre-of-pressure passes anterior to the shank statistically significantly earlier in stance²³
  • Increased minimum instantaneous COM velocity during prosthetic-limb single support phase²³
  • Reduced peak negative COP velocity²⁵
  • Reduced COP posterior travel distance²⁵

  Improved ground compliance when walking on slopes

  • Increased plantarflexion range during slope descent¹⁹
  • Increased dorsiflexion range during slope ascent¹⁹

  Less effort on residual hip for trans-femoral amputees on varied terrains

  • Reduced the mean hip extension and flexion moments²⁷

  Effects consistent over time

  • Same gait variable changes in two gait lab sessions one year apart²²
  • Magnitude of changes comparable between sessions²²

  Brake mode during slope descent to control momentum build up

  • Reduced mean prosthetic shank angular velocity in single support²⁸
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work²⁸

  Less gait compensation movements during slope descent

  • Reduced residual knee flexion at loading response²⁸
• Residual Limb Health

  Helps protect vulnerable residual limb tissue, reducing likelihood of damage

  • Reduced peak stresses on residual limb²⁹
  • Reduced stress RMS on residual limb²⁹
  • Reduced loading rates on residual limb²⁹
• Loading Symmetry

  Greater contribution of prosthetic limb to support during walking

  • Increased residual knee peak extension moment²²
  • Decreased residual knee peak flexion moment²²
  • Increased residual knee negative work²⁴

  Reduced reliance on sound limb for support during walking

  • Reduced intact limb peak hip flexion moment²⁴
  • Reduced intact limb peak dorsiflexion moment²⁴
  • Reduced intact ankle negative work and total work²⁴
  • Reduced intact limb total joint work²⁴

  Better symmetry of loading between prosthetic and sound limbs during standing on a slope

  • Degree of asymmetry closer to zero for 5/5 amputees²⁰

  Reduced residual and sound joint moments during standing of a slope

  • Significant reductions in both prosthetic and sound support moments³⁰

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment³⁰
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres³⁰

  Less pressure on the sole of the contralateral foot

  • Peak plantar-pressure³¹

  Improved gait symmetry

  • Reduced stance phase timing asymmetry³²
• User satisfaction

  Patient reported outcome measures indicate improvements

  • Mean improvement across all Prosthesis Evaluation Questionnaire domains³³
  • Bilateral patients showed highest mean improvement in satisfaction³³

  Subjective user preference for hydraulic ankle

  • 13/13 participants preferred hydraulic ankle³¹

   

Improvements in Clinical Outcomes using Linx compared to non-microprocessor-control hydraulic ankle-feet

• Safety

  Improved knee stability on the prosthetic side during slope descent

  • Increased mid-stance external prosthetic knee extensor moment¹⁹
• Mobility

  Improved ground compliance when walking down slopes

  • Reduced time to foot flat²⁸

  Brake mode during slope descent increases resistance to dorsiflexion to control momentum build up

  • Reduced dorsiflexion range during slope descent¹⁹
  • Reduced mean prosthetic shank angular velocity in single support²⁸
  • Increased Unified Deformable Segment (prosthetic ‘ankle’) negative work²⁸
  • Transition from dorsiflexion to plantarflexion moment occurs earlier in stance phase³⁴
  • Increase in mean prosthetic ‘ankle’ plantarflexion moment integral³⁴

  Assist mode during slope ascent decreases resistance to dorsiflexion to allow easier progression

  • Transition from dorsiflexion to plantarflexion moment occurs later in stance phase³⁴
  • Decrease in mean prosthetic ‘ankle’ plantarflexion moment integral³⁴

  Less gait compensation movements during slope descent

  • Reduced residual knee flexion at loading response²⁸
• Loading Symmetry

  Greater reliance on prosthetic side for bodyweight support during slope descent

  • Increased support moment integral³⁴

  Less reliance on sound side for bodyweight support during slope descent

  • Decreased support moment integral³⁴

  Less reliance on sound side for bodyweight support during slope ascent

  • Decreased support moment integral³⁴

  Reduced sound joint moments during standing of a slope

  • Significant reductions in sound support moment³⁰

  Reduced residual joint moments during standing of a slope for bilateral amputees

  • Significant reductions in prosthetic support moment³⁰
  • Permitted ‘natural’ ground reaction vector sagittal plane position, relative to knee joint centres³⁰
• User satisfaction
  • Greater prosthetic confidence in slope descent and gait termination¹⁶

Mini BladeXT

Clinical Outcomes using e-carbon feet

• Safety
  • High mean radius of curvature for Esprit-style e-carbon feet²: “The larger the radius of curvature, the more stable is the foot”
• Mobility
  • Allow variable running speeds³
  • Increased self-selected walking speed⁴
  • Elite-style e-carbon feet (L code VL5987) or VT units demonstrate the second highest mobility levels, behind only microprocessor feet⁵
• Loading symmetry
  • Users demonstrate confidence in prosthetic loading during high activity⁶
  • Improved prosthetic push-off work compared to SACH feet⁷
  • Increased prosthetic positive work done⁴
• User satisfaction
  • High degree of user satisfaction, particularly with high activity users⁸

Multiflex

Clinical Outcomes using Multiflex feet

• Safety
  • Low stiffness at weight acceptance leads to early foot-flat and greater stability for lower mobility patients¹⁴
  • No loss of stability during standing with Multiflex than fixed ankle/foot¹⁵
  • Easier to walk on uneven ground with Multiflex than fixed ankle/foot^15,16
  • Easier to walk up a slope with Multiflex than fixed ankle/foot¹⁵
• Mobility
  • Little to no difference in gait mechanics compared to flexible, “energy storing” prosthetic feet¹⁷
  • Increased prosthetic ankle range-of-motion with Multiflex compared to fixed ankle/foot^15,16,18-20
  • Increased prosthetic ankle power with Multiflex compared to fixed ankle/foot for bilateral users¹⁶
  • Prosthetic rollover shape closer to natural biomechanics than fixed ankle/foot¹⁸
  • Bilateral users can walk longer distances and report “smoother” gait with Multiflex compared to fixed ankle/foot¹⁶
  • Benefits in mobility for bilateral users^15,16,18,19
• Residual Limb Health
  • Equivalent socket comfort to higher technology, energy-storing feet²¹
• Loading symmetry
  • Improved stance phase timing symmetry with Multiflex compared to fixed ankle/foot²⁰
  • Reduced sound limb loading with Multiflex compared to fixed ankle/foot²⁰
• User satisfaction
  • Majority of users rate Multiflex as either “good” or “acceptable”²² and bilateral users prefer Multiflex to fixed ankle/foot¹⁶

Navigator

Clinical Outcomes using Navigator

• Mobility
  • Shorter keel allows for more consistent rollover radius of curvature, regardless of changing footwear¹
  • The most energy efficient radius of curvature for a rollover shape has been identified as 30% of the walker’s leg length. For a person of a typical adult height between 1.5m and 1.8m, this equates to approximately 245-290mm. Navigator has a rollover shape of ~250mm¹.

Clinical Outcomes using Multiflex-style ankles

• Safety
  • Low stiffness at weight acceptance leads to early foot-flat and greater stability for lower mobility patients¹⁵
  • No loss of stability during standing with Multiflex than fixed ankle/foot¹⁶
  • Easier to walk on uneven ground with Multiflex than fixed ankle/foot^16,17
  • Easier to walk up a slope with Multiflex than fixed ankle/foot¹⁶
• Mobility
  • Little to no difference in gait mechanics compared to flexible, “energy storing” prosthetic feet¹⁸
  • Increased prosthetic ankle range-of-motion with Multiflex compared to fixed ankle/foot^16,17,19-21
  • Increased prosthetic ankle power with Multiflex compared to fixed ankle/foot¹⁷
  • Prosthetic rollover shape closer to natural biomechanics than fixed ankle/foot¹⁹
  • Users can walk longer distances and report “smoother” gait with Multiflex compared to fixed ankle/foot¹⁷
  • Benefits in mobility for bilateral users^17,19-21
• Residual Limb Health
  • Equivalent socket comfort to higher technology, energy-storing feet²²
• Loading symmetry
  • Improved stance phase timing symmetry with Multiflex compared to fixed ankle/foot²¹
  • Reduced sound limb loading with Multiflex compared to fixed ankle/foot²¹
• User satisfaction
  • Majority of users rate Multiflex as either “good” or “acceptable”²³ and prefer Multiflex to fixed ankle/foot¹⁷

Orion3

Improvements in Clinical Outcomes using microprocessor-controlled prosthetic knees

• Safety
  • Significantly reduced number of falls^1,2
  • Reduced centre-of-pressure fluctuations by 9-11% with standing support active when standing on sloped ground³
  • Less cognitive demand during walking, leading to reduced postural sway⁴
• Mobility
  • Increased walking speed⁵
  • Easier to walk at different speeds⁶
  • Higher scores in mobility-related patient-reported outcome measures⁷
  • More natural gait^6,8
  • Easier to walk on slopes⁶
• Energy expenditure
  • Reduced energy expenditure compared to mechanical knees^9-13
  • Equivalent energy expenditure to other MPKs¹⁴
  • Reduced self-perceived effort^6,8
  • Energy expenditure closer to that of able-bodied control subjects¹⁵
  • Able to walk further before becoming tired⁶
• Symmetry
  • Better step length symmetry⁵
  • Reduced loading asymmetry with standing support active when standing on sloped ground³
• User satisfaction
  • Reduced fear of falling¹
  • Reduced limitations due to an emotional problem⁸
  • Preference over other prosthetic knees^1,14
• Health Economics
  • Reductions in direct and indirect healthcare costs when using an MPK¹⁶

Silcare Breathe Cushion Liner

Clinical Outcomes using Sweat Management liners

• Residual Limb Health
  • Improvements in residual limb health problems and wound healing^1,2
  • Fewer residual skin issues²
  • Reduction in pain in residual and phantom limb²
  • Improved heat dissipation compared to other temperature regulation solutions³
  • Removes sweat from skin interface^1,2,4
  • Perforations do not damage the skin⁴
• User satisfaction
  • Patients reported a preference for their perforated liners^1,4
  • Reduces the need to remove prosthesis throughout the day to dry residual limb⁴
• Clinical Outcomes using Silicone liners

  There are two published literature reviews that discuss different aspects of lower limb prosthetic liner technology^5,6.

  • The main purpose of prosthetic liners is to cushion the transfer of loads from the prosthetic socket to the residual limb⁵.
  • Based on load-displacement data from the compressive stiffness tests, silicone was one of three materials that were recommended for situations where it is desirable for the liner to maintain thickness and volume since these materials had the least non-recovered strain^5,7.
  • Under cyclic compressive loading, silicone was one of two materials that had the greatest cycles to failure under compressive loading, while the Pedilin and polyurethane samples lasted orders of magnitude less^5,8.
  • Prosthetic liners and sockets are highly resistive to heat conduction and could be a major contributor to elevated skin temperatures^5,9.
  • There are reduced residual limb pressures with the silicone liner compared to other conditions (no liner; soft inserts) suggesting that silicone has an ability to distribute pressure evenly to the residual limb^4,10.
  • In terms of patient outcomes, there was no clear preference between silicone and Pelite liners^5,11.

Silcare Breathe Locking Liner

Clinical Outcomes using Sweat Management liners

• Residual Limb Health
  • Improvements in residual limb health problems and wound healing^1,2
  • Fewer residual skin issues²
  • Reduction in pain in residual and phantom limb²
  • Improved heat dissipation compared to other temperature regulation solutions³
  • Removes sweat from skin interface^1,2,4
  • Perforations do not damage the skin⁴
• User satisfaction
  • Patients reported a preference for their perforated liners^1,4
  • Reduces the need to remove prosthesis throughout the day to dry residual limb⁴
• Clinical Outcomes using Silicone liners

  There are two published literature reviews that discuss different aspects of lower limb prosthetic liner technology^5,6.

  • The main purpose of prosthetic liners is to cushion the transfer of loads from the prosthetic socket to the residual limb⁵.
  • Based on load-displacement data from the compressive stiffness tests, silicone was one of three materials that were recommended for situations where it is desirable for the liner to maintain thickness and volume since these materials had the least non-recovered strain^5,7.
  • Under cyclic compressive loading, silicone was one of two materials that had the greatest cycles to failure under compressive loading, while the Pedilin and polyurethane samples lasted orders of magnitude less^5,8.
  • Prosthetic liners and sockets are highly resistive to heat conduction and could be a major contributor to elevated skin temperatures^5,9.
  • There are reduced residual limb pressures with the silicone liner compared to other conditions (no liner; soft inserts) suggesting that silicone has an ability to distribute pressure evenly to the residual limb^4,10.
  • In terms of patient outcomes, there was no clear preference between silicone and Pelite liners^5,11.

SmartIP

Improvements in Clinical Outcomes using prosthetic knees with microprocessor-controlled swing phase

• Safety
  • Less cognitive demand during walking, leading to reduced postural sway¹
• Mobility
  • Increased walking speed^2-5
  • Easier to walk at different speeds^4,6
  • More natural gait⁴
  • Easier to walk on slopes^4,6
• Energy Expenditure
  • Reduced energy expenditure compared to (non-MPK) mechanical knees^3-8
  • Equivalent energy expenditure to other MPKs (swing and stance controlled)⁹
  • Reduced self-perceived effort^4,6
  • Energy expenditure closer to that of able-bodied control subjects¹⁰
  • Able to walk further before becoming tired⁴
• Symmetry
  • Better step length symmetry^2,6
• User satisfaction
  • Preference over other prosthetic knees^4,6

SuperSACH

Clinical Outcomes using SACH feet

• Safety
  • Low stiffness at weight acceptance leads to early foot-flat and greater stability for lower mobility patients¹
• Mobility
  • Satisfactory for patients with limited mobility in order to maintain mobility level²
  • Lightweight keel increases ease of use and is ideal for elderly users or those with limited strength²
  • Durability tests confirm foot to be long-lasting for those with low mobility levels³
• User satisfaction
  • 54% satisfaction rate²
  • Satisfaction rates increase within the bilateral population²