Evaluation of the new, patient-adjustable socket system Varos in the early phase of prosthetic rehabilitation: a pilot study.

Abstract

Current prosthetic sockets often provide limited anatomical fit, especially in patients with residual limb volume changes and fluctuations. To address these issues, Ottobock has developed the Varos Socket, a modular socket that can be adjusted by the user. The aim of this study was to evaluate the potential benefits and acceptance of a newly designed patient-adjustable socket in transfemoral amputees in early phase of prosthetic rehabilitation. A prospective A-B-A pilot study was conducted. The setting of the study was an Orthopedic Rehabilitation Clinic. Ten patients with unilateral transfemoral amputation and recent amputation. All patients underwent a standard rehabilitation program with physical therapy. The outcome measures included the Comprehensive Lower-limb Amputee Socket Survey (CLASS), Score Comfort Scale (SCS), a Socket Fit Scale, frequency of falls and stumbles, perceived pain, and satisfaction. The total CLASS score and three sub-scores (i.e., stability, suspension, comfort) were significantly higher with Varos socket. Significantly improved comfort and quality of socket fit were observed as measured by the Socket-Comfort-Scale and Socket-Fit-Scale and a trend towards reduced residual limb pain. 87.5% of the patients reported higher satisfaction than with the standard socket. The results suggest that the Varos socket improved comfort, stability, suspension, appearance, pain, and satisfaction in transfemoral amputees during the early rehabilitation program. A larger study and a longer observation period are warranted to confirm the results of this study. Quick and easy socket fitting as well as instant adjustability by the patient bear substantial potential to improve and accelerate the rehabilitation process in the early phase after amputation.