At a glance
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Development of Adaptive Vacuum Suspension to Improve Prosthetic Fit and Residual Limb Health
In Brief
A clinical study evaluating Active vacuum test prosthesis for Lower Limb Amputation. Completed, enrolled 60 participants across 1 site.
Detailed Summary
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket. The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also significantly impact an amputee's limb health. If the prosthesis is not held securely to the amputee's limb, relative movement between the limb and prosthetic interface can cause bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can lead to much more serious health conditions. A positive solution to creating secure and comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists in preventing movement in the socket. The clinical benefits associated with vacuum suspension include volume retention, increased proprioception, secure suspension, and frequently reported observations of wound healing. However, the long term effects of vacuum suspension on circulation remain undetermined or undocumented. This study examines a vacuum suspension system on the health of the residual limb (amputated limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin of the residual limb.
Study Details
Timeline
Interventions
The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.