Investigation Into the Functional Performance of a New Thermoplastic Elastomer (TPE) Transtibial Liner

Amputation Stumps

The clinical investigation is designed as an uncontrolled open prospective, multicenter, 2 group, pre-test post-test study. Testing will be conducted in the USA and Canada at 3-6 clinics, depending on enrolment requirements. 20 subjects currently using the comparator liner will be recruited: 10 using cushion/sleeve and 10 using pin-lock. The study consists of 4 study events, requiring subjects to visit the clinic at least 4 times; as this study requires the manufacturing of a new socket, more than one iterations might be required. These events will be as follows

The study is of an uncontrolled open prospective multicentre 2 group pre-test post-test design. i) Recruitment phase Potential subjects will be identified from the customer base of the Local Principal Investigator (LPI). LPI evaluates, based on previous experience of interaction with and servicing of patients, if a potential participant is cognitively capable. If a potential participant fits the inclusion and exclusion criteria the LPI will contact them via telephone. During the telephone call the LPI will verify if they are interested in participating in a study. If interest is expressed at this point they will answer some screening questions and if the eligibility criteria are met an appointment will be made for the clinical visit and signing of the ICF. Questions relating to the duration of the study, number of clinical visits required and the investigational device will be answered. The LPI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate. ii) Test procedure 3-10 users will be recruited at each site. User Profile instrument will be filled in at the initial visit. It will be filled in by the CPI/LPI with input from the subject. Baseline instrument will also be filled in at the initial visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ - Residual Limb Health (PEQ-RLH), Comfort and other (noise and satisfaction). They only include VAS items and comment boxes. Additionally the pistoning test output is documented at the end. The first part, socket fit comfort, of the Socket fitting instrument will be administrated each time as required, depending on iterations needed. CPO feedback, usability and comfort will only be administrated when the subject comes in for the first time for the fitting. The 2 week follow up instrument will be administrated at the 2 week post successful fitting visit. It consists of 5 parts: Usability, Suspension Questionnaire, PEQ-RLH, and Comfort and Other; same as Baseline. Additionally the pistoning test output for both the trial liner (ICEROSS TPE) and is ICEROSS COMFORT is documented at the end. The Retrofitting instrument is also administrated at study event 3 (expected visit 3). The instrument used at the 6 month follow up consists of 4 parts: Suspension Questionnaire, PEQ-RLH, Comfort, and Other. The Other part has additional questions compared to the instruments used at earlier visits. All items are in-house developed except for the socket fit comfort score\[4\] and PEQ-RLH\[5\]. iii) Visit Schedule and forms to fill out There are at least four scheduled study events. Each visit, except when fitting to trial product will take approximately 2 hours. The trial product fitting visits (event nr. 2, 2a, 2b, etc.) should last for no more than 30 minutes. The first event is a visit within the normal treatment procedures of prosthetic care when the users are measured for a new socket. The ICF will be signed prior to any study activity. During the visit the subjects will also fill in the User Profile and Baseline instruments, with the help of their CPO as required. This test, as is standard for liner testing, requires that the users will be fitted with a new socket. Attaining a proper fit of a new socket requires at least one iteration, often more, and few days to complete, and hence some users might require more study visits than others. The second study event will be 1-2 weeks post first visit, when the new socket is ready. Subjects will come in and fit the new socket while wearing the investigational device. To verify that the socket is acceptable subjects will be asked to fill in the Socket fitting instrument. If the outcome is positive the subject will be scheduled for the 2 week follow up and subject goes home with the new prosthetic liner. If not, a new socket must be made or adjustments to the one manufactured and another visit set up for this event. The third study event is the 2 week follow up. During the visit the subject will fill in the 2 week follow up instrument and the Retrofitting instrument, after retrofitting. Subject keeps using the investigational device. The final study event, and expected fourth visit, is at 6 months post successful fitting. The subject fills in the 6 month follow up instrument, receives compensation as applicable and ends study participation. The subjects will return the trial device at the 6 month visit.

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United States