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Clinical Studies on Liners and Locks

In order of most recent publication first:

  • 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


      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.

      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.

      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.

      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.  Rehabilitacion, 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.