Clinical Investigation of Performance and Safety of ProsFit O. Sockets
Research type
Research Study
Full title
Clinical Investigation of the Performance and Safety of ProsFit Original Prosthetic Sockets
IRAS ID
162635
Contact name
Alan Hutchison
Contact email
Duration of Study in the UK
0 years, 2 months, 10 days
Research summary
The clinical investigation is designed to determine the performance and safety* of ProsFit Original prosthetic sockets and their use by amputee patients, including a comparison to the patients’ own traditionally manufactured sockets (a prosthetic socket is externally-applied as the container in which the residual limb (residuum) is embedded, and attached to the prosthesis assembly (collectively: prosthesis)). The investigation is constructed to be similar to the socket-fitting process that amputee patients are familiar with as part of standard clinical practice.
Each participant will undergo a medical and fitness assessment including training in using the Alter-G (‘anti-Gravity’) Treadmill. Each participating patient (with informed consent) will be fitted with a ProsFit Original prosthetic socket. There are 6 Phases of mobility testing in the protocol. Outcome measures will be taken at specific intervals, and will include: Socket comfort score, TAPES, EQ-5D-5L, PCI. AMPnoPro, 2 min. walk test, 6 min. walk test, Visual analogue score (pain), and berg balance score. The questionnaires and outcome measure that are not self-questionnaires will be administered by a member of the team. Each participant’s own traditionally manufactured socket may also be used in certain visits as a comparator (randomized, single-blind).
The investigation involves approximately 12-15 participants and should take 10 weeks overall. Each individual participant’s involvement is planned over 5-6 weeks, with 4-6 visits.
Two main cohorts are recruited before the investigation – 1) Regular users of the device, with activity level of SIGAM E or F, and, 2) High-intensity users (e.g. athletes, military veterans, etc.).
*Performance and safety of a prosthetic socket includes the ability to connect to a prosthesis assembly and be used as defined, in a comfortable way that enables walking over durations expected, with an acceptable style of walking (gait), over a long-term period of regular use, and without device deficiencies or provoked adverse events.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1373
Date of REC Opinion
19 Dec 2014
REC opinion
Further Information Favourable Opinion