ASSIST

Summary

After patients have a below-knee amputation, they are fitted with an artificial leg or ‘prosthesis’. The connection between the remaining limb and the prosthesis is called the socket. It is traditionally manufactured by taking a plaster-cast mould of the patient’s residual limb, before fabricating a polypropylene or laminate socket.

The patient’s residual limb often changes shape during the first-year post-amputation, necessitating the fabrication of a new socket.

A different type of socket can be used to the traditional, ‘usual care’ socket. It is shaped directly onto the remaining limb and can be re-shaped in future by heating it (i.e. it is remouldable). This type of socket may improve patient outcomes by making the socket fit better and readjusting the shape more quickly so patients can walk sooner and may reduce waiting times and manufacturing costs.

What we plan to do

The ASSIST study aims to inform the feasibility of conducting a future randomised controlled trial to evaluate the clinical and cost effectiveness of a remouldable socket system compared to the traditional socket for patients with a transtibial (below-knee) amputation who are being fitted for their first prosthesis.

80 patients with a below-knee amputation who are expected to receive a prosthesis will be recruited from up to 5 NHS prosthetics centres. They will be randomised to receive either the remouldable socket (intervention) or usual care socket (control). Recruitment rates and times across prosthetics services will be determined.

Patients will be asked to rate their quality of life, socket comfort, function with a prosthesis and adjustment to using a prosthesis. Number of clinic visits, manufacturing time and time to receipt of socket/prosthesis will be compared between groups, and patients and healthcare professionals will be asked about their experiences of the sockets.