Prosthesis UserNCT04388488
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
A study testing CONNECT TF adaptable socket system and Any conventional handmade socket in people with Prosthesis User and Amputation, run by Össur Iceland ehf at 2 sites in United States.
Trial summary
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthesis User, Amputation
- What is being tested?
- CONNECT TF adaptable socket system and Any conventional handmade socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2020to 25 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Lower limb amputees
- Uni- or bilateral TF amputees
- 40 < body weight < 125Kg
- Activity level: K1-K2;
- Liner size: 28-45;
- Max 1 user in sizes 28 and 45, respectively
Show all 12Show fewer
- Residual limb parameters; perineum to distal end: 205 to 280 mm
- Older than 18 years
- Prosthetic users for more than 3 months
- Components of conventional socket functionally compatible to Össur components (foot-pylon-knee combination)
- Users understanding the function of the device
- Willing and able to participate in the study and follow the protocol
Who cannot join
- Other amputees
- 40> body weight > 125Kg
- Amputees with broken skin on the residual limb
- Younger than 18 years
- Prosthetic users for less than 3 months
- Using no liner
- Using a microprocessor controlled prosthetic knee not manufactured by Össur
- Users not understanding the function of the device
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
IU Health Comprehensive Wound Center at Methodist Hospital
Indianapolis, Indiana, 46206-1367
About this study
Official title: Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System for
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.
Read the detailed description
Design:
This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design comparing subject´s current conventional socket and the CONNECT TF. The subjects will be asked to use the CONNECT TF as their primary prosthesis for up to six weeks. Subject will be fitted with the same foot-pylon-knee prosthetic system as used with their current conventional socket, with the CONNECT TF socket.
Procedures:
There are four scheduled study events. At the initial visit, the first study event, for each subject a qualified researcher will obtain an informed consent. Prior to fitting the patient subject to CONNECT TF he/she will be asked to provide feedback and perform tasks on/using their current conventional prosthetic socket. The patient subjects will be fitted with the CONNECT TF within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
The CPO (Certified Prosthetis/Orthotist) will conduct the fitting and aligning of the CONNECT TF.
A Co-Investigator will time the fitting procedure; from unpacking the device until it is correctly adjusted and properly fit to the subject.
Data on initial feedback on the device will be collected from the subjects using the instruments specified above. Afterwards an appointment at 2 weeks is made and the subjects leave the clinic on the device.
If the fitting of CONNECT TF fails, i.e. the PI/CPO does not manage to fit the device properly or the subject cannot use the device as intended during training at the clinic, a new appointment is made, if the subject is willing to continue participation.
The second event will be according to the appointment scheduled 2 weeks earlier. During this visit the same set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A 6 week follow up (6WFU) visit is scheduled and the subject leaves on the CONNECT TF socket.
The third event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A final 6WFU visit is scheduled and the subjects are fitted back to and leave on their current conventional socket.
The fourth event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. End of study.
Data analysis:
The dataset will be assessed with inferential statistics based on the acceptance criteria for the data, as applicable.
Outcomes at each time point will be visually inspected for normality using histograms and qq-plots. If the data are deemed to be normal the hypothesis will be tested using a two-tailed, paired, student's t-test for 2WFU evaluation and mixed models for the 6WFU evaluation. Non-normal data will be tested using the Wilcoxon signed-rank test.
- Conditions
- Prosthesis User, Amputation
- Being tested
- CONNECT TF adaptable socket system, Any conventional handmade socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECT TF adaptable socket systemDevice
Prefabricated, adaptable socket system
Any conventional handmade socketDevice
Subjects current socket
| Study group | Role | What they receive |
|---|---|---|
| Conventional socket compared to Connect TF Socket | Experimental | The investigation will be of a non-randomized single group open label prospective repeated measures (ABBA) design Receives: Device: CONNECT TF adaptable socket system; Device: Any conventional handmade socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Total Score
The Comprehensive Lower-limb Amputee Socket Survey (CLASS) is a participant-reported measure of prosthetic socket satisfaction for individuals with lower-limb amputation. The questionnaire evaluates perceived socket stability, suspension, comfort, and appearance during common activities. Responses are combined to generate a total score, which is converted to a percentage of the maximum possible score. Scores range from 0% to 100%, with higher percentages indicating greater satisfaction and better perceived socket performance.
Measured: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Secondary outcomes (4)
Residual Limb Health Subscale Score (PEQ-RLH)
The Residual Limb Health (RLH) subscale of the Prosthesis Evaluation Questionnaire (PEQ) is a participant-reported outcome measure assessing perceived residual limb health while using a prosthesis. The RLH subscale consists of 6 items addressing issues such as perspiration, odor, swelling, skin irritation, and other residual limb problems. Each item is rated on a 0-10 Likert-type scale. Item scores are summed and converted to a percentage of the maximum possible subscale score, resulting in a score ranging from 0% to 100%, where higher percentages indicate better residual limb health and fewer residual limb problems.
Measured: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Prosthesis Evaluation Questionnaire (PEQ) Sounds Subscale Score
The Sounds subscale of the Prosthesis Evaluation Questionnaire (PEQ) assesses the participant's perception of sounds generated by the prosthesis during use. The subscale consists of 2 items. Responses are averaged to produce a subscale score. Scores range from 0 to 10 likert scale, where higher scores indicate a more favorable outcome (less bothersome prosthetic sounds/noise).
Measured: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Mobility (2-Minute Walk Test)
The 2-Minute Walk Test (2MWT) is a performance-based measure of walking capacity. Participants were instructed to walk as far as possible in 2 minutes. The total distance walked during the test was recorded in meters. Greater distances indicate better mobility and walking endurance.
Measured: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Balance During Ambulation (Timed Up and Go Test [TUG])
The Timed Up and Go (TUG) test is a performance-based measure of functional mobility and balance. Participants were instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the task was recorded in seconds. Lower completion times indicate better mobility and balance performance.
Measured: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start3 Aug 2020
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prosthesis UserStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Responsible party
- Sponsor
- Investigators
- Sashwati Roy, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388488
- Sponsor's protocol ID
- CIP2020021338
- Status last verified
- Sep 2025
- First submitted
- 30 Apr 2020
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System for
- ClinicalTrials.gov ID
- NCT04388488
- Acronym / sponsor ID
- CIP2020021338
- Conditions
- Prosthesis User, Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- Indiana University
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.
Detailed description
Design:
This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design comparing subject´s current conventional socket and the CONNECT TF. The subjects will be asked to use the CONNECT TF as their primary prosthesis for up to six weeks. Subject will be fitted with the same foot-pylon-knee prosthetic system as used with their current conventional socket, with the CONNECT TF socket.
Procedures:
There are four scheduled study events. At the initial visit, the first study event, for each subject a qualified researcher will obtain an informed consent. Prior to fitting the patient subject to CONNECT TF he/she will be asked to provide feedback and perform tasks on/using their current conventional prosthetic socket. The patient subjects will be fitted with the CONNECT TF within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.
The CPO (Certified Prosthetis/Orthotist) will conduct the fitting and aligning of the CONNECT TF.
A Co-Investigator will time the fitting procedure; from unpacking the device until it is correctly adjusted and properly fit to the subject.
Data on initial feedback on the device will be collected from the subjects using the instruments specified above. Afterwards an appointment at 2 weeks is made and the subjects leave the clinic on the device.
If the fitting of CONNECT TF fails, i.e. the PI/CPO does not manage to fit the device properly or the subject cannot use the device as intended during training at the clinic, a new appointment is made, if the subject is willing to continue participation.
The second event will be according to the appointment scheduled 2 weeks earlier. During this visit the same set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A 6 week follow up (6WFU) visit is scheduled and the subject leaves on the CONNECT TF socket.
The third event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A final 6WFU visit is scheduled and the subjects are fitted back to and leave on their current conventional socket.
The fourth event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. End of study.
Data analysis:
The dataset will be assessed with inferential statistics based on the acceptance criteria for the data, as applicable.
Outcomes at each time point will be visually inspected for normality using histograms and qq-plots. If the data are deemed to be normal the hypothesis will be tested using a two-tailed, paired, student's t-test for 2WFU evaluation and mixed models for the 6WFU evaluation. Non-normal data will be tested using the Wilcoxon signed-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design.
| Arm | Type | Receives |
|---|---|---|
| Conventional socket compared to Connect TF Socket | Experimental | Device: CONNECT TF adaptable socket system, Device: Any conventional handmade socketThe investigation will be of a non-randomized single group open label prospective repeated measures (ABBA) design |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Lower limb amputees
- Uni- or bilateral TF amputees
- 40 < body weight < 125Kg
- Activity level: K1-K2;
- Liner size: 28-45;
Key exclusion criteria (8 listed)
- Other amputees
- 40> body weight > 125Kg
- Amputees with broken skin on the residual limb
- Younger than 18 years
- Prosthetic users for less than 3 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 |
|---|---|---|
| CONNECT TF adaptable socket systemPrefabricated, adaptable socket system | Device | Conventional socket compared to Connect TF Socket |
| Any conventional handmade socketSubjects current socket | Device | Conventional socket compared to Connect TF Socket |
Primary outcome
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Total Score
Time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
The Comprehensive Lower-limb Amputee Socket Survey (CLASS) is a participant-reported measure of prosthetic socket satisfaction for individuals with lower-limb amputation. The questionnaire evaluates perceived socket stability, suspension, comfort, and appearance during common activities. Responses are combined to generate a total score, which is converted to a percentage of the maximum possible score. Scores range from 0% to 100%, with higher percentages indicating greater satisfaction and better perceived socket performance.
4 secondary outcomes
Residual Limb Health Subscale Score (PEQ-RLH)
Time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Prosthesis Evaluation Questionnaire (PEQ) Sounds Subscale Score
Time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Mobility (2-Minute Walk Test)
Time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Balance During Ambulation (Timed Up and Go Test [TUG])
Time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sashwati Roy, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNECT TF adaptable socket system and Any conventional handmade socket in people with Prosthesis User and Amputation, run by Össur Iceland ehf at 2 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 12 inclusion and 8 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Comprehensive Lower-limb Amputee Socket Survey (CLASS) Total Score (time frame: Visit 1 (Baseline), Visit 2 (2 weeks), Visit 3 (6 weeks), and Visit 4 (12 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 21 Oct 2026.