Adjustable-volume prosthetic sockets: Market overview and value propositions

Abstract

The prosthetic socket is commonly considered to be the most important part of the prosthesis and lack of fit can lead to skin breakdown, reduction in wear, reduction in activity, and consequential deleterious health effects. Furthermore, approximately 90% of amputations are due to a vascular etiology, which affect fluid retention regularity, and even small limb volume fluctuations can lead to lack of fit. Adjustability in the socket volume has been suggested as a potential solution to common fit issues but has lacked market penetration mostly due to lack of reimbursement. Despite this there are several adjustable-volume sockets emerging on the market today including prefabricated, modular, custom with adjustable-volume component, custom with adjustable-volume feature, and adjustable-hybrid sockets. Prefabricated sockets are mass produced in common sizes and fit directly to the patient by a prosthetist using pad kits, BOA dials, or straps. Modular sockets are assembled to a patient or model with panels or struts attached to an adjustable base. Custom sockets with adjustable-volume elements are traditionally-fabricated sockets made to a model of a patient's limb with a volume-adjustable component added or volumeadjustable feature built in. Custom-hybrid sockets are made custom to a model of the patient's limb and incorporate several aspects of the previous socket types and include some radically-unique design aspects which cannot be limited to one category. These adjustable-volume sockets offer several advantages to traditional rigid-volume sockets for the patient, prosthetist, and providing clinic. The microadjustability for the patient allows them to alter fit without removing the socket, maintaining a more intimate fit throughout the day than traditional sockets. The macro-adjustability for the prosthetist allows for increased options for fit customization including the ability to reverse or undo changes without necessarily re-making the socket. This allows for the most optimal fit for the patient. Adjustable volume also present efficiencies in the fitting process by simplifying or eliminating steps including residual limb shape capture, form modification, diagnostic fabrication, iterative alteration, and definitive fabrication with the different socket types affecting different steps. Due to these factors, adjustable-volume sockets have disrupted the market to the point where reimbursement reform is needed including additional L-codes in the United States and fee-for-service or fee-for-outcome associated with prosthetic follow-up care. Prosthetic care should also be separated from durable medical equipment to allow for alternative reimbursement models. As reimbursement adapts prosthetists must adapt correspondingly to differentiate their skillset from other allied health providers including incorporating more objective methods to show superior care outcomes. This adaptation should include a continued push for state and municipal licensure of prosthetists.