AmputationNCT02678247
Functional Performance Evaluation of NU-FlexSIV Socket
A study testing Northwestern University Flexible Sub-Ischial Vacuum Socket and Ischial Containment Socket in people with Amputation and Artificial Limbs, run by Northwestern University at 3 sites in United States.
Trial summary
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Amputation, Artificial Limbs
- What is being tested?
- Northwestern University Flexible Sub-Ischial Vacuum Socket and Ischial Containment Socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2016to Dec 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unilateral transfemoral amputation
- have used a prosthesis for two or more years
- have a residual limb that is stable in volume and free from wounds
- be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
- have no previous experience of the sub-ischial socket
- able to complete all visits for the duration of the protocol
Who cannot join
- have a residual limb femur of less than 5-inches
- co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
- do not speak and read English
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Jesse Brown VA Medical Center Motion Analysis Research Laboratory
Chicago, Illinois, 60611
Northwestern University Prosthetics-Orthotics Center
Chicago, Illinois, 60611
Scheck and Siress Prosthetics Orthotics
Oakbrook Terrace, Illinois, 60181
About this study
Official title: Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
Read the detailed description
The proposed clinical trial will be an assessor-blinded prospective randomized cross-over trial wherein participants with unilateral transfemoral amputation will be randomized to using one of two socket conditions (i.e., sub-ischial or ischial containment) before crossing over to the other socket condition. Random allocation (computer-generated) utilizing blocks of random size will be used to assign the initial treatment condition. The trial will be balanced such that all subjects will receive all treatments (i.e., both socket conditions) and that all subjects will participate for the same number of periods (i.e., two). While a washout period is not strictly necessary, it is effectively included as subjects will need to transition back to their usual, pre-study socket/prosthesis while the second test socket is fabricated.
Allocation of intervention will be concealed from the investigators until after a subject is enrolled. The starting socket design will be enclosed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and other details are written on the appropriate envelope.
Blinding of prosthetic interventions is challenging given that they are devices that must be custom-fabricated and donned each day by the subject. Hence, for this study only the assessor will be blinded. The blinded assessor will be responsible for administration of the clinical performance and patient-reported measures as well as processing of motion analysis data.
- Conditions
- Amputation, Artificial Limbs
- Being tested
- Northwestern University Flexible Sub-Ischial Vacuum Socket, Ischial Containment Socket
- Keywords
- prosthesis, prosthetic socket, transfemoral amputation, socket comfort, gait biomechanics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Northwestern University Flexible Sub-Ischial Vacuum SocketDevice
Also called NU-FlexSIV Socket
NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.
Ischial Containment SocketDevice
Also called IC Socket
Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.
| Study group | Role | What they receive |
|---|---|---|
| NU-FlexSIV Socket | Active comparator | The Northwestern University Flexible Sub-Ischial Vacuum Socket is a novel socket design for transfemoral amputees. Receives: Device: Northwestern University Flexible Sub-Ischial Vacuum Socket; Device: Ischial Containment Socket |
| IC Socket | Active comparator | The Ischial Containment Socket is the standard of care socket design for transfemoral amputees. Receives: Device: Northwestern University Flexible Sub-Ischial Vacuum Socket; Device: Ischial Containment Socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks.
Socket comfort was assessed after each socket was worn for 7 weeks. SCS is an ordinal scale where the subject responds to the question, "On a 0 to 10 scale, if 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit, how would you score the comfort of the socket of your artificial limb at the moment?"
Measured: 7 weeks
Secondary outcomes (11)
Walking Speed Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Walking speed was assessed after each socket was worn for 7 weeks. Participants walked along a 12 meter, level walkway at their normal self-selected speed. Marker based motion capture was used to assess walking speed (m/s).
Measured: 7 weeks
Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Step length was assessed after each socket was worn for 7 weeks. Participants walked along a 12 meter, level walkway at their normal self-selected speed. Marker based motion capture was used to assess step length (cm).
Measured: 7 weeks
Hip Extension Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Hip extension was assessed after each socket was worn for 7 weeks. Participants walked along a 12 meter, level walkway at their normal self-selected speed. Marker based motion capture was used to assess hip extension (degrees).
Measured: 7 weeks
Hip Range of Motion Between the IC Socket and NU-FlexSIV Socket 7 Weeks.
Hip range of motion was assessed after each socket was worn for 7 weeks. Participants walked along a 12 meter, level walkway at their normal self-selected speed. Marker based motion capture was used to assess hip range of motion (degrees).
Measured: 7 weeks
Trunk Motion Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Trunk motion was assessed after each socket was worn for 7 weeks. Participants walked along a 12 meter, level walkway at their normal self-selected speed. Marker based motion capture was used to assess trunk motion (degrees).
Measured: 7 weeks
Orthotics and Prosthetics Users' Survey (OPUS) Lower-Extremity Functional Status Measure Between the IC Socket and NU-FlexSIV Socket at 7 Weeks
Lower-Extremity Functional Status was assessed after each socket was worn for 7 weeks. The OPUS Lower-Extremity Functional Status measure is a self-report instrument that assesses functional status in persons who use orthoses and prostheses. It is comprised of 20 items rated on a 5-point rating scale. Responses to items are summed to produce a total score for the measure (0 to 80) with higher scores representing better functional status.
Measured: 7 weeks
Orthotics andProsthetics Users' Survey (OPUS) Health Related Quality of Life Index Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Health Related Quality of life was assessed after each socket was worn for 7 weeks. The OPUS Health Related Quality of Life measure is self-report instrument comprised of 23 items that are evaluated with a 5-point rating scale. Responses to items are summed to produce a total score for the index (0 to 92) with higher scores representing better quality of life.
Measured: 7 weeks
Orthotics and Prosthetics Users' Survey (OPUS) Satisfaction With Device Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Satisfaction with Device was assessed after each socket was worn for 7 weeks. The OPUS Satisfaction with Device measure is a set of 11 items rated on a 5-point rating scale. Responses to items are summed to produce a total score. 9 items were used in this study for a possible score of 9 to 45 with higher scores representing better satisfaction.
Measured: 7 weeks
5-Times Rapid Sit-to-Stand Test (RSTS) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
The 5-Times Rapid-Sit-to-Stand Test was assessed after each socket was worn for 7 weeks. Participants were asked to rise from a chair of standard height five times as fast as possible with their arms folded across their chests. Performance was timed.
Measured: 7 weeks
Four-Square-Step Test (FSST) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
The Four-Square-Step Test was assessed after each socket was worn for 7 weeks. Four sticks were placed flat on the floor in a cross that denoted a square. Participants were asked to complete a stepping sequence as fast as possible. Performance was timed.
Measured: 7 weeks
T-Test of Agility (T-Test) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
The T-Test was assessed after each socket was worn for 7 weeks. Four markers were set out so a "T" could be traced among them. The subject was asked to move as fast as possible between the markers, moving forwards, sideways and backwards. Performance was timed and reported in seconds.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2019
- Study completionDec 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Jesse Brown VA Medical Center, Scheck and Siress
- Responsible party
- Principal investigator, Stefania Fatone, PhD, BPO(Hons), Northwestern University
- Investigators
- Stefania Fatone, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678247
- Sponsor's protocol ID
- W81XWH-15-1-0708
- Status last verified
- May 2021
- First submitted
- 2 Feb 2016
- Last updated
- 15 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Upon request, the PI will share de-identified data and outcomes. If the requests are excessive, data will be made available via a link on the Northwestern University Prosthetics-Orthotics Center (NUPOC) website.
Publications
Fatone S, Stine R, Caldwell R, Angelico J, Gard SA, Oros M, Major MJ. Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1515-1523. doi: 10.1016/j.apmr.2022.02.013. Epub 2022 Mar 13.
PubMed 35296398Fatone S, Caldwell R, Angelico J, Stine R, Kim KY, Gard S, Oros M. Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.
PubMed 34214499
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Performance Evaluation of the Northwestern University Flexible Sub-Ischial Vacuum (NU-FlexSIV) Socket for Persons With Transfemoral Amputation
- ClinicalTrials.gov ID
- NCT02678247
- Acronym / sponsor ID
- W81XWH-15-1-0708
- Conditions
- Amputation, Artificial Limbs
- Keywords
- prosthesis, prosthetic socket, transfemoral amputation, socket comfort, gait biomechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Jesse Brown VA Medical Center, Scheck and Siress
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to provide a more comfortable and functional prosthetic socket for persons with transfemoral amputation that will ultimately improve their quality of life.
Detailed description
The proposed clinical trial will be an assessor-blinded prospective randomized cross-over trial wherein participants with unilateral transfemoral amputation will be randomized to using one of two socket conditions (i.e., sub-ischial or ischial containment) before crossing over to the other socket condition. Random allocation (computer-generated) utilizing blocks of random size will be used to assign the initial treatment condition. The trial will be balanced such that all subjects will receive all treatments (i.e., both socket conditions) and that all subjects will participate for the same number of periods (i.e., two). While a washout period is not strictly necessary, it is effectively included as subjects will need to transition back to their usual, pre-study socket/prosthesis while the second test socket is fabricated.
Allocation of intervention will be concealed from the investigators until after a subject is enrolled. The starting socket design will be enclosed in sequentially numbered, opaque, sealed envelopes. Envelopes will be opened sequentially and only after the participant's name and other details are written on the appropriate envelope.
Blinding of prosthetic interventions is challenging given that they are devices that must be custom-fabricated and donned each day by the subject. Hence, for this study only the assessor will be blinded. The blinded assessor will be responsible for administration of the clinical performance and patient-reported measures as well as processing of motion analysis data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NU-FlexSIV Socket | Active comparator | Device: Northwestern University Flexible Sub-Ischial Vacuum Socket, Device: Ischial Containment SocketThe Northwestern University Flexible Sub-Ischial Vacuum Socket is a novel socket design for transfemoral amputees. |
| IC Socket | Active comparator | Device: Northwestern University Flexible Sub-Ischial Vacuum Socket, Device: Ischial Containment SocketThe Ischial Containment Socket is the standard of care socket design for transfemoral amputees. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unilateral transfemoral amputation
- have used a prosthesis for two or more years
- have a residual limb that is stable in volume and free from wounds
- be physically fit enough to participate in the performance tests (Medicare Functional Classification Level K3 or K4)
- have no previous experience of the sub-ischial socket
Key exclusion criteria (3 listed)
- have a residual limb femur of less than 5-inches
- co-morbidities that affect function, including neurologic abnormalities (e.g. neuropathic pain that would interfere with the study)
- do not speak and read English
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 |
|---|---|---|
| Northwestern University Flexible Sub-Ischial Vacuum SocketAlso: NU-FlexSIV SocketNU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket. | Device | IC Socket, NU-FlexSIV Socket |
| Ischial Containment SocketAlso: IC SocketIschial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort. | Device | IC Socket, NU-FlexSIV Socket |
Primary outcome
Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks.
Time frame: 7 weeks
Socket comfort was assessed after each socket was worn for 7 weeks. SCS is an ordinal scale where the subject responds to the question, "On a 0 to 10 scale, if 0 represents the most uncomfortable socket fit you can imagine, and 10 represents the most comfortable socket fit, how would you score the comfort of the socket of your artificial limb at the moment?"
11 secondary outcomes
Walking Speed Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Hip Extension Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Hip Range of Motion Between the IC Socket and NU-FlexSIV Socket 7 Weeks.
Time frame: 7 weeks
Trunk Motion Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Orthotics and Prosthetics Users' Survey (OPUS) Lower-Extremity Functional Status Measure Between the IC Socket and NU-FlexSIV Socket at 7 Weeks
Time frame: 7 weeks
Orthotics andProsthetics Users' Survey (OPUS) Health Related Quality of Life Index Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Orthotics and Prosthetics Users' Survey (OPUS) Satisfaction With Device Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
5-Times Rapid Sit-to-Stand Test (RSTS) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Four-Square-Step Test (FSST) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
T-Test of Agility (T-Test) Between the IC Socket and NU-FlexSIV Socket at 7 Weeks.
Time frame: 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35296398Fatone S, Stine R, Caldwell R, Angelico J, Gard SA, Oros M, Major MJ. Comparison of Ischial Containment and Subischial Sockets Effect on Gait Biomechanics in People With Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2022 Aug;103(8):1515-1523. doi: 10.1016/j.apmr.2022.02.013. Epub 2022 Mar 13.
- Derived from this study: PubMed 34214499Fatone S, Caldwell R, Angelico J, Stine R, Kim KY, Gard S, Oros M. Comparison of Ischial Containment and Subischial Sockets on Comfort, Function, Quality of Life, and Satisfaction With Device in Persons With Unilateral Transfemoral Amputation: A Randomized Crossover Trial. Arch Phys Med Rehabil. 2021 Nov;102(11):2063-2073.e2. doi: 10.1016/j.apmr.2021.05.016. Epub 2021 Jun 29.
- Individual participant dataSharing planned: Yes. Upon request, the PI will share de-identified data and outcomes. If the requests are excessive, data will be made available via a link on the Northwestern University Prosthetics-Orthotics Center (NUPOC) website.
Related trials for Amputation
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
Recruiting
Bio Leg: Advancing Mobility (BAM)
Amputation of Lower Limb Above Knee, Amputee
Recruiting
Prosthetic Socket Fit Testing System
Amputation
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.
Stefania Fatone, PhD principal investigator
Northwestern University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Northwestern University Flexible Sub-Ischial Vacuum Socket and Ischial Containment Socket in people with Amputation and Artificial Limbs, run by Northwestern University at 3 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 6 inclusion and 3 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 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 27 Apr 2021). 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?
Socket Comfort Score (SCS) Between IC Socket and NU-FlexSIV Sockets at 7 Weeks. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02678247, which also lists 2 linked publications.
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 15 Jun 2021.