Clinical investigation of the performance and safety of ProsFit original prosthetic sockets

Not Applicable

Completed

• Conditions: Prosthetic sockets for below-knee amputees; Not Applicable; Prosthetic sockets

• Registration Number: ISRCTN14301627
• Lead Sponsor: ProsFit Technologies UK Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2015-03-14
• Study Start: 2015-03-17
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

1. Amputee with trans-tibial amputation
2. Aged 18 years or above
3. Patient of SMRC
4. Activity Level Special Interest Group in Amputee Medicine (SIGAM) grade E or F (no significant limitations on walking distance, no use of walking aids, able to walk up shallow slopes and climb stairs, near normal gait or normal gait)
5. Willing and able to attend the planned research Visits, giving full attempt to adhere to the Investigation protocol in good faith (the patient may withdraw from the study at any point, without necessarily providing any reasons for doing so)
6. Willing and able to provide informed consent
7. Has a prosthesis that allows for its components to be disconnected from the traditional socket and then to be connected to the ProsFit Original prosthetic socket, and reconnected back, for the purposes of the research (connecting and reconnecting done by the prosthetist of the investigation team)
8. Uses an appropriate roll-on liner (this is worn between the residuum and the socket for cushioning and prosthesis suspension purposes) and is willing to use it during the Investigation
9. Willing to also use their own socket (non-ProsFit) as a comparator
10. Patient is expected to attend the clinic before and/or during the period in which the clinical investigation is taking place
11. No conflicts of interest related to participation or the results of the Investigation

Exclusion Criteria

1. Pre-existing medical conditions that might put the patient at risk or lead to a failure to complete the study. This includes diabetes, ischaemic heart disease (angina), epilepsy, skin conditions that might lead to skin breakdown such as Ehlers-Danlos Syndrome, chronic obstructive airway disease.
2. Current acute medical conditions such as skin infections, stump sores / blisters or recent trauma to the stump
3. Under 18
4. Mental health disorders that may lead to difficulties with participation or understanding protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified