| Registry | NCT05279885 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: none, supportive care |
| Enrollment | 13 (Actual) |
| Sponsor | Jóna Valgerður Kristjánsdóttir (Industry); collaborators: Indiana University |
| Conditions | Prosthesis User |
| Interventions | Vented suspension system, Non-vented suspension system (Device) |
| Dates | start 2021-10-22, primary completion 2022-03-10, completion 2022-03-10, first posted 2022-03-15, last updated 2026-10-21 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Prosthesis User All trials of Vented suspension system All trials of Non-vented suspension system
The objective of the investigation is to measure the humidity within a transfemoral amputee's prosthesis during physical activity in a pre-heated room, using both the vented AeroFit system and a non-vented comparator.
The AeroFit System is a vented suspension system for transfemoral amputees, and it is combined with both a vented liner and a vented socket. Both the liner and the socket are designed to allow humidity to evaporate from the residual limb skin and out of the socket. The system is intended to reduce sweat build-up on the amputees' residual limb.
At least ten transfemoral amputees will be fitted to the AeroFit socket and liner. After a minimum of 2 weeks of adaptation, subjects will have two humidity measurement sessions on two separate days, one day for the investigational device and one for the comparator. Each measurement session will take place during the same time of the day.
During the humidity measurement sessions, humidity and temperature sensors will be placed directly on the subject's residual limb, and the subject will walk for 20 minutes at self-selected walking speed on a treadmill in a pre-heated room of 28 degrees Celsius. After 20 minutes of walking and 10 minutes of rest, the subject will perform the four square step test and walk stairs and humidity and temperature measurements will be collected throughout the whole time. After the stairs activity, the subject will be seated and will remove the socket, liner and sensors.
The subject group will be randomized into two groups, A and B. Group A's first measurement session will be using the investigational device, Group B's first measurement session will be using the comparator.
Amputees often deal with sweat inside their prostheses, which can affect their suspension and skin health. The Aerofit system is intended to assist with that problem. The investigation is the first step in collecting a pivotal dataset to confirm the sweat build-up inside amputees' prosthesis is reduced with a breathable suspension system.
The clinical investigation will be a pre-market, confirmatory, pivotal clinical investigation. The clinical investigation will be designed to collect data on the effectiveness and clinical performance of AeroFit, the investigational device. Burden to subjects is interventional. Results from early feasibility clinical investigation on objective humidity measurements on skin indicate that the vented AeroFit TF system (investigational device) reduces the amount of humidity collected on skin during period of exercise in heated room compared to non-vented suspension system. Self-reported measures indicate no worse experience with the new vented system with regards to subjects perceived comfort, suspension and stability.
Investigational device will be Aerofit system, a vented liner and socket system which allows for humidity evaporation from subject.
The clinical investigation is a randomized cross-over design. Measurements on comparator and investigational device will be randomized.
The primary objective of the investigation will be to evaluate the efficacy of the vented investigational device compared to conventional non-vented suspension system regarding measured relative humidity on skin during increased perspiration. Secondary objectives are to evaluate if the measured moisture reduction during increased perspiration results in reduction in perceived moisture on skin. Tertiary objectives are to evaluate equivalent perceived system stability, suspension and comfort between investigational device and comparator.
Absorbent sweat patches will be used to collect quantifiable measures on amount of sweat collected on skin after the physical activity. Outcome from sweat patches measurement will only be exploratory. The patches will be analyzed to generate a microbiology culture report for exploratory purposes without related hypothesis. Outcomes from stair walking and FSST will also be exploratory.
The following clinical claims are to be evaluated:
* Measured moisture on skin is reduced
* Perceived moisture on skin is reduced
* Perceived stability is no worse
* Perceived suspension is no worse
* Perceived comfort is no worse
The subjects will use the investigational device (AeroFit System) for 3-10 weeks. Formal testing days for humidity measurements will be two days for each subject. Approximately 3-4 hours/day, one day for comparator testing and one day for investigational device testing.
Testing days will take place 2-9 weeks after the subject has been fitted to the investigational device. A minimum of 2 weeks adaptation time will be required before testing takes place.
After testing days have been completed, subject will get a new appointment at the clinic, and will be fitted back to their prescribed device.
From being fitted to the investigational device and until subjects are back to prescribed device, subjects are expected to use the investigational device for their daily living activities as they would with any other prosthesis, for up to 18 hours a day depending on the amputee.
The comparator device will be Össur Seal-In Silicone Liner in combination with AeroFit Socket. The holes of the socket will be sealed with a silicone sheet during testing for the purpose of closing off holes and thereby prevent any moisture evaporation from the socket. The chance of moisture evaporation is extremely small when subject is using enclosed silicone liner underneath an open socket, but to completely prevent the possibility, the holes will be sealed. The function of the AeroFit Socket, during comparator testing, will therefore be the same as a standard, enclosed, Direct Socket. The Össur Seal-In Silicone liner has the same intended use as the AeroFit Liner. Furthermore, it is indicated for the same condition and population group. It is a widely accepted device, providing clinical benefits to the user, and one of the most common type of such a device on the market.
The subject will be using the remaining part of their current prosthetic system (prosthetic knee and foot) with the investigational device, as it is used with the comparator device.
No other device, medication or intervention will be used. 10 subjects are to be enrolled and therefore 10 investigational systems (socket and liner) will be used for testing, as the devices are intended to be used by a single subject: one for each subject. All subjects will be provided with two AeroFit TF liners to use during daily activities, before and after the humidity measurement days.
Procedures There are six scheduled study events.
Screening Potential subjects will be identified from the customer base of SRT, the National Prosthetic Center. Co-Investigator (CI) 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 CI will contact them via telephone. During the telephone call the CI will verify if they are interested in participating in a study. If interest is expressed at this point, CI will go through the enrollment log and if the eligibility criteria is met an appointment will be made for the first site 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.
Potential risk of participating in the investigation will be explained to the subject at this point.
The CI will communicate to the PI and study monitor the number of users he has identified that meet the inclusion criteria and are willing to participate.
Training and protocol test run Training and protocol test run will take place prior to start of formal investigation procedures and data collection. Sponsor research assistances will handle training and take part in protocol procedures test run.
Visit 1 - Informed Consent and Investigational Device fitting At the initial visit, the first study event, for each subject a researcher qualified to obtain informed consent will seat the subject and proceed as described in chapter 13.8 Informed consent.
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.
Next, subject will be randomized into either group A or B. Group A will start with visit 2A, Group B will start with visit 2B. Randomization allocation will be done using envelopes including either the letter A or B. 10 subjects are required to complete the protocol procedures and therefore 5 envelopes will be prepared per letter.
Visits 2A and 2B - Humidity measurements in heated room (28 degrees Celsius), functional tests, and questionnaires.
* Visit 2A: Investigational Device humidity measurements
* Visit 2B: Comparator humidity measurements Visits 2A and 2B will take place on two separate days, during the same time of the day.
Humidity measurement procedure is the same for investigational device and comparator. Only difference is that for comparator testing, additional silicone sheets will be used to close socket body holes prior to test procedures start. Additionally, absorbent sweat patches will be placed on the participant's skin surface with the purpose of utilizing Gravimetric techniques for microbial analysis and in order to collect quantifiable measures on amount of sweat collected on subjects' skin after physical activity in heated room.
Visit 3 Fitting back to prescribed device. All subjects will be fitted within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
The investigational device will be provided as needed for the study population. Devices will not be packaged but will be labeled according to FDA regulatory requirements. Subjects will not be blinded.
The LPI will keep records documenting the receipt, use and return of the investigational device in the Investigational Device Management Form.
Statistical design and procedures The area under the relatively humidity curve from the time of donning the liner to the time of exiting the hot room will be the primary outcome to assess the efficacy of the intervention. The test liner will be compared to the control liner using a generalized linear model. Relative humidity at the time point immediately prior to liner donning will be included in the model as a covariate.
Perceived sweat will be compared with a one-sample, two-tailed t-test. All CLASS subscales will be compared using a one-tailed Wilcoxon-Signed-Ranks test.
Acceptance criteria for the data, as applicable, is defined in Table 6 Endpoints, test methods and hypotheses. Subgroup analysis will not be performed as no subgroups are defined.
Sample size calculation It is expected that 10 subjects are required to complete the protocol with a power of 0.95 and significance at 0,05. Effect size was estimated based early feasibility investigation results.
For pass/fail criteria, see Table 6 Endpoints, test methods and hypotheses.
Additional statistical matters There is no provision for interim analysis and no criteria for early termination of the clinical investigation on statistical grounds.
Any deviations from the statistical plan provided in this protocol will have to be approved by the sponsor and the reasons for the deviation reported in the clinical investigational report. Dropouts and withdrawn participants will be included in the data analysis for the procedures that they completed. They will be grouped together and compared to the group that finished the protocol. Any statistical differences of the two groups will be reported. If the participants have not provided any data, they will not be included in the data analysis. No particular information will be excluded from the statistical analysis and tests, as described above.
The clinical investigation is sponsored by Össur Iceland ehf.
It shall be conducted:
* in accordance with the ethical principles that have their origin in the Declaration of Helsinki
* in compliance with the ISO 14155 International Standard
* in compliance with any regional or national legislations, as applicable The clinical investigation shall not commence until the required approval from the IRB/REB/REC, and regulatory authority as applicable, has been obtained.
Any additional requirements imposed by the IRB/REB/REC or regulatory authority shall be followed, as applicable.
Subjects are provided with health insurance with expenses covered of up to 5.000.000 USD relating to any adverse health outcomes in relation the clinical investigation.
A patient using the investigational device may or may not benefit clinically from using the device vis-a-vis using another Össur Seal-In® TF silicone liner and Direct Socket commercially available.
Expected benefits while using the investigational device:
* Measured moisture on skin is reduced
* Perceived moisture on skin is reduced
* Perceived stability is no worse
* Perceived suspension is no worse
* Perceived comfort is no worse Compared to not using an Össur Seal-In® TF silicone liner and Direct Socket, in combination with the remaining part of the prosthesis, the patient will benefit significantly in terms of mobility and ability to live independently. Further on the user will be trained on a new prosthetic component to experience the unprecedented functionality of the new component to mitigate the known deficiencies associated with his amputation.
Additionally, the benefit for the user during the testing is that he/she helps in developing a new and novel vented Össur TF silicone liner and socket design.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Group A - Vented Suspension System First, Non-vented Second | Other | Device: Vented suspension system; Device: Non-vented suspension system | Subjects will be randomized in to two groups, A and B. Group A starts with humidity measurements on vented suspension system. |
| Group B - Non-vented Suspension System First, Vented Second | Other | Device: Vented suspension system; Device: Non-vented suspension system | Subjects will be randomized in to two groups, A and B. Group B starts with humidity measurements on non-vented suspension system. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 50Kg< body weight < 136Kg * Cognitive ability to understand all instructions and questionnaires in the study * Unilateral/ bilateral trans-femoral amputee * Able to walk on a treadmill for 20 minutes * Using Össur Seal-In Silicone Liner and Direct Socket * Stump Length: Subjects must fall into the predefined criteria for minimum stump length dependent on liner size and residual limb shape * Direct Socket Length: Subjects must fall into the predefined criteria for minimum socket length dependent on liner size and residual limb shape. Measured from the distal end of the socket to the lowermost point on the medial side of the socket. * Residual limb profile: Standard or conical * Willing and able to participate in the study and follow the protocol * Confident prosthetic users for more than 3 months * Older than 18 years Exclusion Criteria: * 50Kg> body weight > 136Kg * Users with cognitive impairment * Participating in another research study * Previous diagnosis or history of cardiovascular disease
| Milestone | Group A - Vented Suspension System First, Non-vented Second | Group B - Non-vented Suspension System First, Vented Second |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 3 |
| Not completed | 0 | 3 |
Time frame: Adverse events were collected from baseline device fitting to final study participation, including both crossover assessment visits and device return (up to approximately 8 weeks)
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Vented Suspension System | 0/13 (0.0%) | 0/13 (0.0%) | 1/13 (7.7%) |
| Non-vented Suspension System | 0/13 (0.0%) | 0/13 (0.0%) | 1/13 (7.7%) |
| Term | Organ system | Vented Suspension System | Non-vented Suspension System |
|---|---|---|---|
| skin irritation | Skin and subcutaneous tissue disorders | 1/13 | 0/13 |
| medical condition | General disorders | 0/13 | 1/13 |
| Facility | City | Country | Status |
|---|---|---|---|
| SRT Prosthetics & Orthotics NPC - National Prosthetic Center | Indianapolis, Indiana | United States |