Prosthetics and Orthotics International - Fondazione Santa Lucia

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476531POI0010.1177/0309364613476531Prosthetics and Orthotics InternationalBrunelli et al. 2013 Original Research Report A comparison between the suction suspension system and the hypobaric Iceross Seal-In ® X5 in transtibial amputees INTERNATIONAL SOCIETY FOR PROSTHETICS AND ORTHOTICS Prosthetics and Orthotics International 0(0) 1 –9 © The International Society for Prosthetics and Orthotics 2013 Reprints and permission: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0309364613476531 poi.sagepub.com Stefano Brunelli 1 , Anna Sofia Delussu 1 , Francesco Paradisi 1 , Roberto Pellegrini 2 and Marco Traballesi 1 Abstract Background: The two passive vacuum suspension systems currently available in total surface-bearing sockets are the hypobaric Iceross Seal-In ® and the suction suspension system. Objectives: The purpose of this study was to compare the effect of the hypobaric Iceross Seal-In ® liner with that of the suction suspension system for quality of life, pistoning, and prosthesis efficiency in unilateral transtibial amputees. Study design: Single-group repeated measures. Methods: Ten amputees were enrolled. The pistoning test, used to compare 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 and the Houghton Scale Questionnaire of perceived mobility and quality of life with the prosthesis, and the Timed Up&Go Test and the Locomotor Capability Index for functional mobility were also administered at the beginning and end of the study. Results: The hypobaric Iceross Seal-In ® X5 led to significant pistoning reduction and improvement on the Houghton Scale Questionnaire and 3 of 9 domains of the Prosthesis Evaluation Questionnaire. No statistical changes were observed in functional mobility or the energy cost of walking tests. Conclusion: Replacing the suction suspension system with the hypobaric Iceross Seal-In ® X5 improves quality of life in transtibial amputees. Clinical relevance 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. Keywords Amputees, lower-limb loss, prosthetic design, suspension Date received: 5 July 2012; accepted: 8 January 2013 Background The efficiency of the prosthesis is mainly guaranteed by its suspension method for securing the socket to the stump. 1 A proper method of prosthetic suspension ensures a well-functioning and safe prosthesis. 2 Transtibial amputees (TTA) reduce their activity and limit prosthetic use because of residual limb problems and discomfort experienced at the socket interface. 3 In fact, the socket is the critical interface between the stump and the prosthesis. 4 Residual limb volume and shape changes lead to gait instability, which causes poor adaptation to the socket by altering limb– socket interface pressure and increasing shear stress. 5 These events occur even in a “mature” residual limb (defined by Berke 6 as >18 months post amputation); in fact, unpredictable individual daily fluctuations of residual limbs were observed in transtibial prosthetic users. 7 Board et al. 8 1 Fondazione Santa Lucia, Scientific Institute for Research, Hospitalization and Health Care, Operative Unit D, Rome, Italy 2 ITOP, Officine Ortopediche, Rome, Italy Corresponding author: Dr Stefano Brunelli, Fondazione Santa Lucia, Scientific Institute for Research, Hospitalization and Health Care, Operative Unit D, Via Ardeatina 306, 00179 Rome, Italy. Email: s.brunelli@hsantalucia.it Downloaded from poi.sagepub.com at Fondazione Santa Lucia on May 22, 2013
2 Prosthetics and Orthotics International 0(0) reported an average 6.5% residual limb volume reduction after only 30 min of walking with a standard Total Surface Bearing (TSB) socket with a one-way valve. Residual limb volume loss due to prosthetic use leads to increased vertical movement of the stump in the socket, called “pistoning.” 9,10 This phenomenon is minimized by a good suspension system that secures the socket to the amputee’s stump, guaranteeing prosthesis efficiency. 1,11 As pistoning increases, fit deteriorates, interface pressure and shear stresses increase, and skin ulcerations may appear and limit the amputee’s mobility and autonomy. 8,11 The range of pistoning in the TSB socket of TTA has been studied using various methods. Board et al. 8 adopted a roentgen approach and applied different loads and found a mean tibia bone displacement relative to the end of the socket of 4 and 3.3 cm for the socket with electric vacuum pump and suction suspension system (SSS), respectively. With the static photographic method, a mean displacement of 0.9 and 1.3 cm was found in the shuttle lock prosthesis during non-weight-bearing and when 30 N was applied, respectively. 12 Using a motion analysis system to investigate the Seal-In ® X5 liners, Gholizadeh et al. reported 0.0, 0.1, 0.1, and 0.2 cm of pistoning in non-weight-bearing, 30, 60, and 90 N conditions, respectively. 1 Many studies have compared different suspension systems. 1,7,8,13–17 As far as we know, however, no articles have been published to date that compare the two passive vacuum suspension systems currently available in TSB sockets, that is, the hypobaric Iceross Seal-In ® (HIS) and the SSS. TSB suction sockets are widely used in clinical practice because of their better fit and suspension. The passive vacuum system is obtained in both systems by means of a one-way valve positioned in the distal part of the socket. This valve creates negative pressure between the liner and the socket. In Össur’s hypobaric Iceross Seal-In ® (HIS) prosthetic liner, the liner holds five silicone hypobaric seals that are able to adapt to the internal surface of the socket, guaranteeing vacuum socket suspension without an external sleeve (Figure 1). 1 In the SSS, the vacuum is obtained by placing a urethane knee sleeve over the proximal onehalf of the exterior socket wall and the distal three-quarters of the thigh (Figure 1). 8 This study aimed to evaluate the influence of the HIS suction system on pistoning, quality of life, and efficiency compared with SSS in unilateral TTA. To achieve our goals, we used the following tests and questionnaires: the pistoning test (PT) to compare vertical movement of the stump within the socket, energy cost of walking (ECW) to check prosthesis efficiency, the Prosthesis Evaluation Questionnaire (PEQ) and the Houghton Scale Questionnaire (HSQ) to evaluate perceived mobility and quality of life with the prosthesis, and the Timed Up&Go Test (TUGT) and the Locomotor Capability Index (LCI) for functional mobility. We were also interested in determining the time needed by a new HIS Seal-In X5 user to reach or surpass the same suspension stability and ECW they had obtained using the SSS. Figure 1. Transtibial suspension systems used in the study. Suction suspension system socket components are on the left and hypobaric Iceross Seal-In ® X5 membrane components are on the right. We hypothesized that the vacuum obtained with the hypobaric seals would provide better socket suspension than that obtained with the external sleeve, and that this would result in less pistoning, and better user satisfaction and performance with the prosthesis. Materials and methods To participate in the study, subjects had to meet the following inclusion criteria: (a) unilateral amputation of lower limb at below-knee level, (b) age 20–65 years, (c) body mass
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