A Prospective Assessment of an Adjustable, Immediate Fit, Subischial Transfemoral Prosthesis.

Objective: To assess the feasibility of an adjustable, subischial transfemoral prosthesis by comparing self-reported outcome measures regarding socket comfort, fit and utility relative to a persons' conventionally made socket. Assessing limb compressibility was another aim of this study. Design: A single-group pre-post intervention design. Setting: Physical medicine and rehabilitation biomechanics laboratory. Participants: All 18 enrolled participants (N = 18) completed the feasibility trial. There were 16 men and 2 women with an average age of 59.4 (±7) years. Most of the participants (61.1%) had worn a socket for 1 to 10 years before the trial, 22.2% of the participants had worn one for less than a year, and 16.7% of the participants had worn a prosthesis for more than 10 years. Intervention: Participants were fit with the study prosthesis and used it for a 2-week home trial. Main Outcome Measures: A Prosthetic Comfort and Utility Questionnaire was completed on the participant's conventional prosthetic device and the subischial socket system after the trial. Results: The adjustable subischial prostheses were rated superior overall to the participant's conventional sockets (40.9 ± 7.2 vs 32.8 ± 10.8; Conclusions: The adjustable, immediate fit, subischial prosthesis provided safe, comfortable, and functional ambulation for persons with transfemoral limb loss in this short-term feasibility study. This study supports the consideration of a new paradigm in transfemoral prosthetics-adjustable subischial sockets. These devices should be tested in a larger multi-center study.