ABSTRACT
BACKGROUND: Current prosthetic sockets often provide limited anatomical fit, especially in patients with residual limb volume changes and fluctuations. AIM: 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. DESIGN: A prospective A-B-A pilot study was conducted. SETTING: The setting of the study was an Orthopedic Rehabilitation Clinic. POPULATION: Ten patients with unilateral transfemoral amputation and recent amputation. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. CLINICAL REHABILITATION IMPACT: 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.
