This design iteration investigation will be a single group prospective repeated measures (AB) design. Up to 25 amputees will be recruited in total from both investigational sites and followed-up for 12 weeks, all subjects will be invited to extend period up to additional 3 months.
Recruitment Potential subjects will be identified from the customer base of the Principal Investigator (PI). PI 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 PI will contact them via telephone. During the phone call the PI will verify if they are interested in participating in a study. If interest is expressed at this point, the CPO will go through the Enrollment Log, subjects will answer some screening questions (Screening Questionnaire) and provide their profile information (Profile).
If the eligibility criteria are met an appointment will be made for Site Visit 1 and signing of the Informed Consent Form. Questions relating to the duration of the study, number of clinical visits required, and the investigational device will be answered.
Potential risk of participating in the investigation will be explained to the subject at this point to the candidate for enrolment.
The PI will communicate to the study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate and provide results from Screening Questionnaire and Profile.
Test procedure There are five scheduled study events. Three investigational site visits. Site Visit 1 (baseline), Site Visit 2 (4 weeks follow-up) and Site Visit 3 (12 weeks follow-up). Two follow-up phone calls will be made, one after 2 weeks and one after 8 weeks, Phone Call Checklists will be administered through phone, including video calls, if applicable.
Up to 25 study subjects will be recruited in total.
Site Visit 1 (baseline):
At the first site visit, a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
Prior to fitting, the subject will provide feedback on their current liner (Study Subject Questionnaire Baseline and Study Subject Usability Baseline).
Next step will be fitting of the investigational device. All subjects will be fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain. Additionally, subjects' sockets will be drilled with holes, as previously described.
It is expected that some subjects might need a new socket, this can be because of limb volume changes and/or other reasons. The Principal Investigator oversees this decision, and if deemed necessary, a new Direct Socket TF will be made, on site, during the time of the first site visit.
At the end of Site Visit 1, all subjects will be provided with a new appointment to come back to the clinic after 4 weeks. All subjects will leave the clinic wearing the investigational device. Subjects will get a copy of the Potential Product Failures Sheet to be able to monitor any product failures and asked to call Principal Investigator, whenever needed.
Each CPO subject will answer one CPO Usability Questionnaire at the end of the Site Visit 1 regarding their experience of fitting/training of the investigational device.
Site Visit 2 (4-week follow-up):
After 4 weeks of using the investigational device, each subject will come in for the second site visit. The main purpose with this visit is for the CPO to meet each subject, evaluate the durability of the investigational device and discuss if there are any problems that have occurred. Subjects will answer Study Subject Questionnaire 4 weeks follow-up and Study Subject Usability 4 weeks follow-up, same set of questions as for baseline.
Follow-up Phone Calls:
Follow-up Phone calls will be made at 2 weeks and 8 weeks and subjects will answer set of check-up questions (Phone Call Checklist).
Site Visit 3 (12-week follow-up):
The last test procedure is the third site visit, subjects will provide feedback on the investigational device by filling in set of questions (Study Subject Questionnaire 12 weeks follow-up). At this point, the condition (durability) of the investigational device will be evaluated by Principal Investigator, CPO and Co-Investigators. If the condition evaluation is deemed acceptable and subject is interested, subjects will be invited to wear the investigational device for up to additional 3 months. If not interested or condition of device is not acceptable, subjects will return their investigational device and will be fitted to their previous device. All will be provided with a new Direct Socket, if needed.
Subjects might be asked to come in for additional visits throughout the study timeline (unscheduled visits) in case of product failure or any other problems that might occur during the investigation that requires further evaluation.
During all site visits, photos will be taken of both baseline liner, test liner and residual limb.
- residual limb
- baseline on limb (only Site Visit 1)
- test liner on limb Also photos of specific current skin issues in any areas on limb All information from site visits and phone calls, including the questionnaires will be sent to study monitor immediately after each procedure, study monitor will report the results to product designers, results will be evaluated, and actions taken if required.
See Table 1 below.
