【米国FDAの承認または認可を受けていない機器の治験】
Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system.
IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 50Kg< body weight < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Unilateral/bilateral trans-femoral amputees
- Activity level: high K2-K4
- Liner: Össur Seal-In TF silicone liner
- Socket: All subjects shall be using Direct Socket, and have been for minimum 4 weeks
- Willing and able to participate in the study and follow the protocol
- Confident prosthetic users for more than 3 months
- Older than 18 years
- Residual limb profile: Standard or conical. At least 30% of subjects must be either conical or standard.
- Subgroup: Minimum 10 subjects shall fit inclusion for subgroup of amputees with history of skin issues.
Exclusion Criteria:
- 50Kg> body weight > 136Kg
- Users with cognitive impairment
- Participating in another research study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：IceExplore TF breathable liner and Direct Socket drilled with holes for additional breathability
The primary objective of this investigation will be to evaluate perceived secure suspension and perceived moisture on skin. The secondary objective will be to evaluate subjects skin health and perceived comfort. Thirdly, to evaluate perceived stability and suspension during increased perspiration and hygiene. Additionally, usability parameters will be explored, both for amputees and CPOs. Amputees usability such as inverting liner, donning/doffing liner and socket, ease of cleaning the liner, number of instances that the user dons/doffs socket per one day and general user satisfaction of the amputee will be explored. Subjects mobility will be evaluated between comparator (baseline) and investigational device with the use of PLUS-M (Prosthetic Limb Users Survey of Mobility). |
The IceExplore TF liners are similar in intended use, methods of operation and materials to other seal-in TF silicone liners manufactured by Össur. The main difference is that the internal structure of the predicate liner is formed entirely of airtight silicone whereas the proximal 70% (approx.) of the IceExplore TF liner consists of a breathable structure, allowing water vapor to move both transversely away from the skin and longitudinally towards the proximal edge of the prosthetic socket. The investigational device is a part of a prosthesis system targeted for users with lower extremity amputation (trans-femoral amputees), physically fit for using a prosthesis to replace the function of an amputated lower limb. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Average Perceived Socket Suspension Score at 12 Weeks Equal or Above 72%
時間枠：12 weeks
|
The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Suspension subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the security of suspension during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized suspension score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived suspension. |
12 weeks
|
|
Difference in Average Perceived Moisture on Skin With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
PEQ item Q is one question from Prosthetic Evaluation Questionnaire (PEQ) - "Over the past four weeks rate how much you sweat inside your prosthesis (in the sock, liner, socket)".
A self-reported measure on a scale from 1-10 were 1 is extreme amount of sweat and 10 is no sweat at all.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference in Average Perceived Skin Health With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
PEQ Residual Limb Health (PEQ-RLH) is a set of 6 questions.
The scale has been validated for internal consistency and temporal stability.
The questions are self-reported on a scale 1-10 about sweat, smell, swollen limb, rashes, ingrown hairs and blisters or sores.
Participants rated each item on a 10-point Likert scale, where higher scores indicated better residual limb health and fewer skin-related problems.
The overall PEQ-RLH score was calculated as the mean of the six item scores
|
12 weeks
|
|
Difference in Average Perceived Comfort With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
The Comprehensive Lower Limb Amputee Socket Survey (CLASS) is a patient-reported outcome measure designed to assess satisfaction with a prosthetic socket across four domains: suspension, stability, comfort, and appearance. Items are rated on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with 0 indicating that an item is not applicable. In this study, the CLASS Comfort subscale was used to evaluate participants' perceived security of prosthetic suspension. Participants rated the socket comfort during four activities: sitting, standing, walking, and ascending or descending stairs. The ratings for all activities were summed and divided by 16, the maximum possible score, to generate a normalized comfort score, with higher scores indicating greater perceived suspension security. The resulting value was multiplied by 100 and reported as a percentage score ranging from 25-100, where higher scores indicate better perceived comfort. |
12 weeks
|
|
Difference in Average Perceived Stability During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
Perceived stability during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, more stability.
"When experiencing increased perspiration, during activities of daily living, I feel stable in the socket".
|
12 weeks
|
|
Difference in Average Perceived Suspension During Increased Perspiration With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
Perceived suspension during increased perspiration, an in-house developed self-report measure on the scale from 1-10, higher number corresponds with a more positive response, better suspension.
"When experiencing increased perspiration, during activities of daily living, suspension between my residual limb and liner feels".
|
12 weeks
|
|
Difference in Average Perceived Hygiene With IceExplore TF Liner and Direct Socket With or Without Holes at 12 Weeks Compared to Össur seal-in Silicone Liners and Direct Socket TF
時間枠：12 weeks
|
Perceived hygiene evaluated with Prosthetic Evaluation Questionnaire, item R (Over the past 4 weeks rate how smelly your prosthesis was at its worst.
A self-reported measure on a scale from 1-10 were 1 is extremely smelly and 10 is no at all smelly.
|
12 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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