Effect of Transfemoral Adjustable-Volume Sockets on Socket Comfort and Quality of Life: A Randomized Controlled Trial.

Objective: To determine if adjustable-volume sockets affect patient comfort and quality of life.

Design: Randomized controlled trial.

Setting: Two prosthetics clinics and 2 research laboratories.

Participants: A convenience sample of individuals with unilateral transfemoral amputation who used prescribed conventional laminated sockets or adjustable-volume sockets (N=29).

Interventions: Each participant was fitted with 3 commercially available adjustable-volume prosthetic sockets that were each used at home for separate 4-week trials. Adjustable socket styles included the Infinite Socket (LIM Innovations), CJ Sail (CJ Socket Technologies), and Quatro (Quorum).

Main outcome measures: The primary outcomes were Socket Fit Comfort Score, Prosthetic Evaluation Questionnaire (PEQ) subscales, socket-specific individual questions from the PEQ, and health-related quality of life (36-Item Short-Form Health Survey). Assessments were conducted after at least 3 weeks of socket use.

Results: Participants abandoned a large number of sockets during the acclimation due to discomfort or instability: CJ (41%), Infinite Socket (25%), and Quatro (24%). When successful, CJ and Quatro sockets improved the Utility, Ambulation, and Social Burden PEQ subscales as well as fit, feel, and sitting comfort compared with the laminated socket. There were a few differences in the Infinite Socket, though it was perceived as having a poorer appearance. Participants who selected adjustable designs at the conclusion of the study reported measurable improvements in socket comfort.

Conclusions: Adjustable-volume sockets offer an alternative to conventional laminated sockets that can positively affect comfort, perceived mobility, and prosthetic utility. Future work should identify the characteristics of individuals that predict success with different socket designs.