Quantification of prosthetic outcomes: elastomeric gel liner with locking pin suspension versus polyethylene foam liner with neoprene sleeve suspension.

For this randomized crossover trial, we compared two common transtibial socket suspension systems: the Alpha liner with distal locking pin and the Pe-Lite liner with neoprene suspension sleeve. Our original hypotheses asserted that increased ambulatory activity, wear time, comfort, and satisfaction would be found with the elastomeric suspension system. Thirteen subjects completed the study. Following 2.5-month accommodation to each condition, ambulatory activity was recorded (steps/minute for 2 weeks), and subjects completed three questionnaires specific to prosthesis use and pain: the Prosthesis Evaluation Questionnaire (PEQ), a Brief Pain Inventory (BPI) excerpt, and the Socket Comfort Score (SCS). Upon completion, subjects selected their favored system for continued use. Ten subjects preferred the Pe-Lite and three the Alpha. Subjects spent 82% more time wearing the Pe-Lite and took 83% more steps per day. Ambulatory intensity distribution did not differ between systems. No statistically significant differences were found in questionnaire results. Subject feedback for each system was both positive and negative.

RCT Entities:   Population Interventions Outcomes