A comparison between the suction suspension system and the hypobaric Iceross Seal-In® X5 in transtibial amputees

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 relevanceThe 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.

Systematic review of effects of current transtibial prosthetic socket designs—Part 2: Quantitative outcomes

“…The most frequent design was a crossover design (n = 9) [27][28][30][31][32][33][41][42][43], followed by five single-subject/case studies [34][35][38][39]44], four randomized crossover trials [13][14]21,29], and three case series [26,[46][47]. The remaining studies were repeated-measure design (n = 1) [45], randomized controlled trials (n = 2) [22,24], cross-sectional design (n = 2) [36][37], and prospective study (n = 1) [40] Table 1.…”

“…Out of these studies, three were classified as having weak evidence [37][38]40], six as having moderate evidence [22,28,33,43,45,48], and two as having robust evidence [13,24]. [45].…”

“…Brunelli et al (DBS 22) reported that people with a TSB socket with sleeve suspension system demonstrated a floor walking speed of 1.72 ± 0.18 m/s [28]. Subjects switched to a TSB socket with hypobaric Seal-In liner and were retested after a familiarization period of 7 wk.…”

“…One study was rated as having robust evidence [13], nine as having moderate evidence [21,[28][29][30][31][32]43,[49][50], and two as having weak evidence [34,44] TSB. Moderate evidence-Based on a case series by Hachisuka et al (DBS 23), pistoning, tightness of socket during walking, and ease of swing were regarded as "good" or "somewhat good" for TSB sockets with laminated silicone liners by more than 75 percent of participants [49].…”

“…Brunelli et al (DBS 22) measured the pistoning movement between two different silicone liners and a TSB socket using digital photography methods [28]. The amount of pistoning during non-weight-bearing was significantly different between the TSB socket with Seal-In liner (3.6 ± 3.1 mm) and the TSB socket with sleeve suspension (7.5 ± 4.7 mm).…”