Recherches et études cliniques (en anglais)

Brunelli, S., Delussu, A. S., Paradisi, F., Pellegrini, R. & Traballesi, M. A Comparison Between the Suction Suspension System and the Hypobaric Iceross Seal-In® X5 in Transtibial Amputees. Prosthet Orthot Int (2013). [Epub ahead of print] doi:10.1177/0309364613476531

Synopsis:

Objective: To compare the effects of the hyperbolic Iceross Seal-In® (Seal- In X5) liner with that of a suction suspension system for quality of life, pistoning and prosthesis efficiency in unilateral transtibial amputees.

Methods: Ten unilaterarally amputated persons were enrolled in the study. The pistoning test (to evaluate vertical movement of the stump within the socket) and the energy cost of walking test were carried out when the amputees were wearing the suction suspension system and after 2, 5, and 7 weeks of Seal-In® X5 use. The Prosthesis Evaluation Questionnaire (PEQ) and the Houghton Scale Questionnaire of perceived mobility and quality of life with the prosthesis (HSQ), and the Timed Up&Go Test (TUGT) and the Locomotor Capability Index (LCI) for functional mobility were also administered at the beginning and end of the study.

Findings: The results showed significantly less displacement (pistoning), 3,9 mm on average, after 7 weeks on the Seal-In X5 liner compared to the suction socket system. Walking speed increased 5.5% on the Seal-In liner compared to the suction socket but the difference was not significant. LCI and TUGT data showed a trend toward improvement using the Seal-In X5 but a statistically significant improvement was observed in HSQ. In addition the PEQ data showed a statistically significant improvement in the “Appearance” domain, that is, the amputees thought the Seal-In X5 liner system prosthesis had a more pleasing appearance.

Interpretation: The study results show that by using the hypobaric Iceross Seal-In® X5, there are fewer pistoning movements in the socket. This is associated with a statistically significant improvement in quality of life, as reported by users. Moreover, Seal-In X5 liner use led to improvement on the HSQ, which indicates more intensive and safe use of the prosthesis. The main indicator of suspension system efficiency in lower-limb prostheses is pistoning in the socket. Reduced pistoning of the hypobaric Iceross Seal-In® X5 may contribute to amputees’ rehabilitation.

Ali S, Abu Osman NA, Naqshbandi MM, Eshraghi A, Kamyab M, Gholizadeh H. Qualitative Study of Prosthetic Suspension Systems on Transtibial Amputees' Satisfaction and Perceived Problems with their Prosthetic Devices. Arch Phys Med Rehabil. 2012 Nov;93(11):1919-23.:

Synopsis:

Objective: To investigate the effects of 3 dissimilar suspension systems on participants' satisfaction and perceived problems with their prostheses.

Methods: Persons with unilateral transtibial amputation (N=243), using prostheses with polyethylene foam liner, silicone liner with shuttle lock, and seal-in liner participated in the study. Questionnaire survey was administered to participants. Descriptive analyses were performed on the demographic information, satisfaction, and prosthesis-related problems of the study participants.

Findings: The results showed significant differences between the 3 groups regarding the degree of satisfaction and perceived problems with the prosthetic device. Study participants were more satisfied with the seal-in liner and experienced fewer problems with this liner. The silicone liner with shuttle lock and seal-in liner users reported significant differences in maintenance time compared with the polyethylene foam liner. Users of the silicone liner with shuttle lock experienced more sweating, while those who used the seal-in liner had greater problems with donning and doffing the device.

Interpretation: The results of the survey provide a good indication that prosthetic suspension is improved with the seal-in liner as compared with the polyethylene foam liner and silicone liner with shuttle lock. However, further prospective studies are needed to investigate which system provides the most comfort and the least problems for participants.

Gholizadeh, H, Abu Osman NA, Kamyab M, Eshraghi A, Lúðvíksdóttir ÁG, Wan Abas WAB. Clinical Evaluation of Two Prosthetic Suspension Systems in a Bilateral Transtibial Amputee. Am J Phys Med Rehabil. 2012 Oct;91(10):894-8.

Synopsis:

Objective: To investigate the effects of 3 dissimilar suspension systems on participants' satisfaction and perceived problems with their prostheses.

Methods: The test subject was a 51-yr-old woman with bilateral transtibial amputation due to peripheral vascular disease. The subject had bony and painful residual limbs, especially at the distal ends. The subject used Seal-in Liners for 2 weeks, on both residual limbs and Dermo liners for 2 weeks. Both conditions had Flex Foot Talux as the prosthetic ankles. Once the 2 wks had passed, the pistoning within the socket was assessed and the patient was questioned as to her satisfaction with both liners.

Findings: This study revealed that Seal-In X5 liner decreased the residual limb pain experienced by the patient and that 1-2 mm less pistoning occurred within the socket compared with the Dermo liner. However, the patient needed to put in extra effort for donning and doffing the prosthesis.

Interpretation: Despite this, it is clear that the Seal-In X5 liner offers a viable alternative for individuals with transtibial amputations who do not have enough soft tissue around the bone, especially at the end of the residual limb.

Gholizadeh H, Osman NA, Kamyab M, Eshraghi A, Abas WA, Azam MN. Transtibial Prosthetic Socket Pistoning: Static evaluation of Seal-In(®) X5 and Dermo(®) Liner using motion analysis system. Clin Biomech. 2012 Jan;27(1):34-9.

Synopsis:

Objective: The objective of this study was to compare the pistoning effect of Seal-In®X5 and Dermo® Liner by using Vicon Motion System.

Methods: Six transtibial amputees, using both the Iceross Seal-In® X5 and the Iceross Dermo® Liner, participated in the study. The vertical displacement (pistoning) was measured between the liner and socket in single limb support on the prosthetic limb (full-weight bearing), double limb support (semi-weight bearing), and non-weight bearing on the prosthetic limb, and also under three static vertical loading conditions (30 N, 60 N, and 90 N).

Findings: The results demonstrated that the pistoning within the socket when Seal-In® X5 was used, decreased by 71% in comparison to the Iceross Dermo® Liner. In addition, a significant difference between the two liners under different static conditions was found (p<0.05).

Interpretation: Seal-in® X5 liner provided less pistoning compared to Dermo® liner.

Tanner, J. and Berke, G. Radiographic Comparison of Vertical Tibial Translation Using Two Types of Suspensions on a Transtibial Prosthesis: A Case Study. J Prosth Orthot, 13, 14-16, 2001.

Synopsis:

Two types of suspensions, the neoprene sleeve and the silicone suction socket suspension with lock, were compared on a single patient by using radiographic measurement of vertical tibial displacement and vertical soft-tissue displacement. The neoprene sleeve suspension allowed 1.8 cm more distal soft-tissue displacement than did the silicone suction socket suspension with a lock. The patient experienced less pistoning with the lock compared to the neoprene sleeve.

Viejo MAG, Huerta MJC. Muscular Atrophy and Demineralization in Low Limb Amputees. Causes and Consequences. Rehabilitation, 34, 285-293, 2000.

Synopsis:

In a study of 47 lower limb amputees (33 transfemoral and 14 transtibial) significant muscular atrophy and bone demineralization was found on both levels of amputation. The authors recommend that the amputees should use silicone liner with shuttle lock to avoid the atrophy and demineralization.

Lake, C. and Supan, T. The Incidence of Dermatological Problems in the Silicone Suspension Sleeve User. J Prosthet Orthot, 9, 97-106, 1997.

Synopsis:

The authors have reviewed pertinent literature on dermatological problems. They suggest the elderly diabetic/PVD amputee would benefit most from silicone suspension due to transfer of shear forces from between the skin and socket to between liner and socket.

Dasgupta, A. K., McCluskie, P. J., Patel, V. S. and Robins, L. The Performance of the ICEROSS Prostheses Amongst Transtibial Amputees with a Special Reference to the Workplace: A preliminary study. Icelandic Roll on Silicone Socket. Occup Med (Lond), 47, 228-36, 1997.

Synopsis:

A clinical trial on randomly selected 27 male transtibial amputees, fitted with ICEROSS. There were overall improvements in comfort and performance of amputees with ICEROSS.

Narita, H., Yokogushi, K., Shii, S., Kakizawa, M. and Nosaka, T. Suspension Effect and Dynamic Evaluation of the Total Surface Bearing (TSB) Trans-tibial Prosthesis: A comparison with the patellar tendon bearing (PTB) trans-tibial prosthesis. Prosthet Orthot Int, 21, 175-8, 1997.

Synopsis:

A clinical X-ray study on nine amputees comparing PTB and TSB sockets with ICEROSS liners. The suspension of the TSB socket with the ICEROSS liner was superior to that of PTB prosthesis. The stability of the TSB prosthesis was statistically better than the PTB prosthesis. 

McCurdie, I., Hanspal, R. and Nieveen, R. ICEROSS--A Consensus View: A questionnaire survey of the use of ICEROSS in the United Kingdom. Prosthet Orthot Int, 21, 124-8, 1997.

Synopsis:

42 doctors and 43 senior prosthetists received a questionnaire about prescribing ICEROSS liners. Positive indications for using ICEROSS liners were pistoning, shear-sensitive skin and insufficient suspension due to change in type or level of activity.

Datta, D., Vaidya, S. K., Howitt, J. and Gopalan, L. Outcome of Fitting an ICEROSS Prosthesis: Views of trans-tibial amputees. Prosthet Orthot Int, 20, 111-5, 1996.

Synopsis:

Outcome of fitting 54 amputees with ICEROSS liners. The amputees considered that the rated stump skin breakdown with ICEROSS liners was significant less compared with the traditional PTB prosthesis. The amputees overall rating of the prosthesis with an ICEROSS liner were scored significantly higher compared to the PTB prosthesis.

Lilja M, Öberg T Knall H, Tovborg-Jensen R. Movements in Prosthetic Sockets: A comparison between ICEROSS and PTB-socket. Abstract Swedish Medical Society, Hygiea. 1994.

Synopsis:

An X-ray study on tibial movements inside prostheses with ICEROSS liners compared to earlier studies on PTB prostheses. A reduction of tibial movements was seen in the ICEROSS prostheses compared to the PTB prostheses.

Cluitmans, J., Geboers, M., Deckers, J. and Rings, F. Experiences with Respect to the ICEROSS System for Trans-tibial Prostheses. Prosthet Orthot Int, 18, 78-83, 1994.

Synopsis:

Some 43 patients participated in this survey. In general all patients perceived the prosthesis with ICEROSS liner to be of benefit. Of the 26 patients who had another prosthesis previously 22 said that they did not whant to go back to previous prosthesis.

Aloe vera studies:

Abdullah, K. M., Abdullah, A., Johnson, M. L., Bilski, J. J., Petry, K., Redmer, D. A., Reynolds, L. P. and Grazul-Bilska, A. T. Effects of Aloe Vera on Gap Junctional Intercellular Communication and Proliferation of Human Diabetic and Nondiabetic Skin Fibroblasts. J Altern Complement Med, 9, 711-8, 2003.

Synopsis:

In vitro study using human type II diabetic and nondiabetic skin fibroblast cell lines. The results demonstrate that Aloe vera has the ability to stimulate GJIC (gap junctional intercellular communication) and proliferation of human skin fibroblasts in diabetes mellitus. Therefore Aloe vera may improve wound healing in diabetes mellitus.

Davis, R. H., Leitner, M. G. and Russo, J. M. Aloe vera. A Natural Approach for Treating Wounds, Edema, and Pain in Diabetes. J Am Podiatr Med Assoc, 78, 60-8, 1988.

Synopsis:

The authors studied Aloe vera as a mode of treatment to alleviate some of the consequences associated with diabetes. As an aid in improving diabetic wound healing the test group showed almost 100% increased wound reduction compared with the control group. They show that Aloe vera is an effective agent in treatment of wounds, edema and pain associated with diabetes.

Two variable damping knees, the magnetorheological-based knee RHEO KNEE by Össur, and the hydraulic-based Otto Bock C-Leg were compared with the mechanically passive, hydraulic-based Mauch SNS Knee by Össur. When using the RHEO KNEE, metabolic rate decreased by 5% compared with the Mauch Knee and by 3% compared with the C-leg. Furthermore, the RHEO KNEE showed an enhanced smoothness of gait, a decrease in hip work production, a lower peak hip flexion moment at terminal stance, and a reduction in peak hip power generation at toe-off compared to the Mauch Knee.

This study compared the Total Knee 2000 to the 3R80. It shows that the Total Knee 2000 increases stability via an increase in velocity, stride length, duration of prosthetic single limb support and a decrease duration of double limb support. Stability, confidence and comfort while walking in crowds, on uneven terrain and while ascending steps was shown subjectively to increase.

Synopsis: The Total Knee demonstrated a slight initial knee flexion during stance, similar to non amputees. Walking velocity and stride length were improved with the knee and overall the gait parameters were more favorable with the Total Knee.

Synopsis: A comparison between Total Knee and OB 3R46. Downhill walking were performed with a higher speed for the Total Knee and the joint were considered to be more stable than the OB 3R46. Total Knee seemed to be the easiest knee to control.

Synopsis: 60 transfemoral amputees were fitted with the Mauch SNS hydraulic knee with a success rate of 93%. 47 patients were available for direct surbey and the clinical evidence have shown that the knee unit is superior to single axis device. The Mauch knee units are recommended for use in the active transfemoral amputees.

Synopsis: The hydraulic Mauch knee were fitted to sixty one transfemoral amputees and only one rejected the knee for another device. A significant majority of the amputees stated that the Mauch knee unit gave them a smoother gait, ability to change cadence together with increased activity level and stability.

Sixteen transtibial amputees [TTAs] were compared to non-amputees when walking up and down a ramp. Conventional 3D gait analysis was carried out when walking with a neutral ankle and with the ankle adapted. When participants walked up a ramp with a dorsiflexed ankle, the kinematics and kinetics were closer to physiological normal gait and the compensation mechanism was reduced. When walking down a ramp, the kinematics and kinetics were less physiological. However, patients reported feeling safer when walking with the adapted ankle, suggesting that PROPRIO also brings about improvements in ramp descent although it does not appear in the gait analysis.

“According to these results [ramp ascent], the increased dorsiflexion was beneficial to the TTAs by improving the kinematics and the kinetics of the lower limb, particularly on the involved side”
“..patients reported benefits by the plantarflexed ankle during ramp descent. They mentioned they felt safer and had a better support during roll over with reduced stress at the knee joint”

View the full article here.

The socket pressures for 12 PROPRIO FOOT wearing, unilateral amputees were measured and synchronised with 3D gait analysis in level, stair and incline walking. The measurements taken on the stairs and incline were done both with the ankle set in neutral and in adaptation mode (dorsi/plantar flexion according to the walking condition). Analysis of the data showed that for incline and stair walking the pressure was more evenly distributed when the foot was used in adaptation mode. Furthermore the socket pressures were closer to that of level ground walking when using the adaptation mode.

“Adapting the prosthetic ankle is a valuable means of modifying joint kinetics and thereby the pressure distribution at the stump”

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Sixteen transtibial amputees were compared to non-amputees when walking on stairs. For the amputees measurements were taking when walking with a neutral ankle and with the ankle adapted to 4 deg dorsiflexion. Analysis showed that gait biomechanics on the stairs were closer to normal when the amputees were using the adapted ankle. In particular, the knee flexion and knee moment on the involved side was improved by the adapted PROPRIO ankle.

“This improved knee function which partially compensates for the absence of ankle motion and proprioception can be regarded as a substantial benefit in the patient group investigated"

“Prosthetic ankles such as the PROPRIO FOOT ® constitute a good alternative for active patients whose life induces a lot of stair ambulation”

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Synopsis: This comparison study objectifiesthe effect of symmetric versus asymmetric foot desing on the progression of center of pressure in the medio-lateral directions. A design with variable medio-lateral characteristics was compared to the conventional symmetric foot design. Objective measurement equipment shows that the use of an asymmetric foot design results in a more natural roll-over of the foot module.

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Synopsis: This is a literature review evaluating energy storage and return and conventional prosthetic feet presented in various studies. Results suggest that while experimental methodologies may limit the statistical significance of objective gait analysis results, consistent trends in temporal, kinetic, and kinematic parameters correlate well with perceptive impressions of DER feet. These correlations provide insight to subtle changes in gait parameters that are deemed neither clinically nor statistically significant, yet are perceived by amputees to affect their preference for and performance of prosthetic feet during locomotion. It is suggested how to design studies revealing more statistical significant results. The Flex-Foot was found to be superior in late stance dorsiflexion.

Synopsis: The study compared three different feet (SACH,Modular III and Re-Flex) in walking at different speeds and running. Five young and active subjects were included in this test. The session were performed on a treadmill measuring energy cost per meter traveled(mL O2/kg/m)
The Re-Flex VSP appears to have a positive effect on energy cost, gait efficiency, and relative exercise intensity compared with other prosthetic foot types during walking and running

Synopsis: This study compared exercise intensity, oxygen uptake and gait efficiency of five male subjects in two test sessions. Active traumatic transfemoral amputees used a SACH foot or a Flex-Foot" attached below a hydraulic knee joint. Walking on level surface at three different speeds was performed. Heart rate was recorded by telemetry, and expired gas was collected. The analysis indicate that the Flex-Foot was associated with significantly lower exercise intensity, less energy expenditure and improved gait efficiency compared to the SACH foot.

Synopsis: The study investigated the effects of prosthetic foot design on the vertical ground reaction forces experienced by the sound limb of seven dysvascular below-knee male amputees. Stride characteristics, joint motion, and ground reaction forces were recorded simultaneously during a self-selected free walking velocity in seven subjects wearing five different prosthetic feet (SACH, Flex-Foot, Carbon Copy II, Seattle, Quantum). The use of the Flex-Foot resulted in the lowest sound limb vertical forces, which appears to be related to its large arc of dorsiflexion motion. In addition, there was increased loading response knee flexion of the sound limb indicating an attempt by these subjects to modulate floor impact. This indicates the Flex-Foot protects the sound limb against excessive vertical forces by virtue of its flexible long keel and large arc of dorsiflexion motion.

Synopsis: Comparison of sound-limb to prosthetic-limb symmetry is the used method to analyze and evaluate different prosthetic feet in this study. Six male vascular amputee showed they benefit from the high range of ankle motion of the Flex-Walk especially when walking inclines

Synopsis: This is a preliminary investigation on a comparison of physiological and biomechanical measurements of three below-knee-amputee and two normal children. Oxygen uptake, heart rate and vertical displacement of a marker approximating the whole body center of mass were measured. One was fitted to a Flex foot and two wore a SACH foot. Measurements were taken on a treadmill in four different speeds. Results indicated the children with the SACH generally displayed greater effort for all walking speeds when compared to respective values of the normal children and the one fitted with the Flex-Foot.

Synopsis: The study on seven male unilateral BK amputees showed significantly differences on the subjects using an FF compared to a CF. It appears the increased length of time the subjects were willing to spend in single support on the FF as compared to the CF allows them to take larger, more normal steps with their uninvolved leg and, hence, they needed fewer steps per minute to match CF walking speeds. Walking with the Flex Foot was associated with a smoother, more uniform vertical trunk motion, suggesting an increase in biomechanical efficiency.