Transfemoral AmputationNCT05925712
Aerofit Post Market Investigation
A study testing AeroFit Seal-In Liner / Socket and Seal-In Silicone Liner in people with Transfemoral Amputation and Amputation, run by Össur Iceland ehf at 7 sites in United States.
Trial summary
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfemoral Amputation, Amputation, Skin Health
- What is being tested?
- AeroFit Seal-In Liner / Socket and Seal-In Silicone Liner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 7 sitesUnited States
- Study dates
- 6 Jun 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50Kg< body weight < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
- Congenital transverse deficiency at femoral level
- Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
- Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8 Minimum socket height per liner profile.
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- Residual limb profile: Standard or conical
- Willing and able to participate in the study and follow the protocol
- Confident (all day) prosthetic users for more than 3 months
- Older than 18 years
Who cannot join
- Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
- Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Baker Orthotics and Prosthetics
Arlington, Texas, 76015
Oakland Orthopedic
Bay City, Michigan, 48708
Gainesville Prosthetics
Gainesville, Florida, 32606
NuTech Institute LLC
Indianapolis, Indiana, 46202
SRT Prosthetics & Orthotics NPC
Indianapolis, Indiana, 46202
Perry Prosthetics
Perrysburg, Ohio, 43551
Reach Orthotics and Prosthetics Services
Virginia Beach, Virginia, 23452
About this study
Official title: Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.
- Conditions
- Transfemoral Amputation, Amputation, Skin Health
- Being tested
- AeroFit Seal-In Liner / Socket, Seal-In Silicone Liner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeroFit Seal-In Liner / SocketDevice
Össur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket.
Seal-In Silicone LinerDevice
Seal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system.
| Study group | Role | What they receive |
|---|---|---|
| Crossover ABA | Experimental | Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. Receives: Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner |
| Crossover BAB | Experimental | Group 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. Receives: Device: AeroFit Seal-In Liner / Socket; Device: Seal-In Silicone Liner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject perceived skin health (PEQ-RLH)
PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH
Measured: 4 weeks
Secondary outcomes (3)
Subject perceived activity restriction and prosthesis use, TAPES-R
Self-report: TAPES-R (Trinity Amputation and Prosthesis Experiences Scales) - Activity Restriction scale Mean of ten 3-point scale items, higher score indicates less restriction
Measured: 4 weeks
Subject perceived quality of life EQ-5D-5L
Self-report: EQ-5D-5L 5-level EQ-5D version (EQ-5D-5L) Use of AeroFit system provides non-inferior quality of life* 0-1.00 index value, higher value indicates higher QALY
Measured: 4 weeks
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
Self-report: In-house generated questionnaire on prosthesis slippage and the need to remove prosthesis due to moisture .
Higher score means worse slippage experience.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start6 Jun 2023
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925712
- Sponsor's protocol ID
- CIP2022020161
- Status last verified
- Oct 2024
- First submitted
- 31 May 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Benefits of a Ventilating Suspension Interface for Individuals With Transfemoral Amputation, a Randomized Controlled Cross-over Trial
- ClinicalTrials.gov ID
- NCT05925712
- Acronym / sponsor ID
- CIP2022020161
- Conditions
- Transfemoral Amputation, Amputation, Skin Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical investigation is to evaluate the clinical benefits of a ventilating suspension interface for individuals with transfemoral amputation. The main aim of the investigation will be to evaluate the clinical user-reported benefits to skin health from using a ventilating lower limb prosthetic suspension system and compare it to a non-ventilating suspension system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crossover ABA | Experimental | Device: AeroFit Seal-In Liner / Socket, Device: Seal-In Silicone LinerGroup 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. |
| Crossover BAB | Experimental | Device: AeroFit Seal-In Liner / Socket, Device: Seal-In Silicone LinerGroup 1 starts using the ventilating suspension system (condition A), group 2 starts using non-ventilating suspension system (condition B) and then they cross-over to the other system, two times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 50Kg< body weight < 136Kg
- Cognitive ability to understand all instructions and questionnaires in the study
- Intended for unilateral/bilateral individuals that fit the indications for use, fit within the specified criteria and with the limb length, shape and ability to use a prosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputation level: transfemoral
- Congenital transverse deficiency at femoral level
- Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFit Socket
Key exclusion criteria (2 listed)
- Participating in another research study that may affect the participation or results of this study (in the opinion of the investigator)
- Users that have received Botox injection as treatment for residual limb sweat issue in the last 4 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeroFit Seal-In Liner / SocketÖssur AeroFit® solution is a transfemoral breathable prosthetic interface, combining the AeroFit® Seal-In liner and AeroFit® Socket. | Device | Crossover ABA, Crossover BAB |
| Seal-In Silicone LinerSeal-In Silicone Lineris transfemoral prosthetic interface used in combination with a prosthetic socket system. | Device | Crossover ABA, Crossover BAB |
Primary outcome
Subject perceived skin health (PEQ-RLH)
Time frame: 4 weeks
PEQ-RLH (Prosthesis Evaluation Questionnaire - Residual Limb Health) Questionnaire Mean of six 1-10 point scale items, higher score indicates better RLH
3 secondary outcomes
Subject perceived activity restriction and prosthesis use, TAPES-R
Time frame: 4 weeks
Subject perceived quality of life EQ-5D-5L
Time frame: 4 weeks
Incidents of prosthesis slippage, the need to remove liner to dry limb or liner and incidents of complete loss of suspension.
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeroFit Seal-In Liner / Socket and Seal-In Silicone Liner in people with Transfemoral Amputation and Amputation, run by Össur Iceland ehf at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject perceived skin health (PEQ-RLH) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.