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| Name | Class |
|---|---|
| United States Department of Defense | FED |
| Jesse Brown VA Medical Center | FED |
| Scheck and Siress | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NU-FlexSIV Socket | Active Comparator | The Northwestern University Flexible Sub-Ischial Vacuum Socket is a novel socket design for transfemoral amputees. |
|
| IC Socket | Active Comparator | The Ischial Containment Socket is the standard of care socket design for transfemoral amputees. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Northwestern University Flexible Sub-Ischial Vacuum Socket | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 7 weeks |
| Step Length Between the IC Socket and NU-FlexSIV Socket at 7 Weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefania Fatone, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jesse Brown VA Medical Center Motion Analysis Research Laboratory | Chicago | Illinois | 60611 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35296398 | Derived | 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. | |
| 34214499 |
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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.
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Once results are published.
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.
30 subjects were randomized.
Recruitment occurred between April 2016 and May 2019. Subjects were recruited and sockets fit and fabricated at local prosthetic clinical care facilities. Data were collected in an academic research lab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ischial Containment Socket Then NU-FlexSIV Socket | Participants first received the Ischial Containment Socket which they wore for 7 weeks, then they received the NU-FlexSIV Socket which they wore for 7 weeks. |
| FG001 | NU-FlexSIV Socket Then Ischial Containment Socket | Participants first received the NU-FlexSIV Socket which they wore for 7 weeks, then they received the Ischial Containment Socket which they wore for 7 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (7 Weeks) |
|
| |||||||||||||||||||||
| Second Intervention (7 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ischial Containment Socket Then NU-FlexSIV Socket | Participants wore the Ischial Containment Socket for 7 weeks then wore the NU-FlexSIV Socket for 7 weeks. |
| BG001 | NU-FlexSIV Socket Then Ischial Containment Socket |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data missing for subjects who withdrew before first data collection session. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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?" | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
7 weeks for each intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ischial Containment Socket | Participants wore the Ischial Containment Socket for 7 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| residual limb skin issue | Injury, poisoning and procedural complications | Non-systematic Assessment | residual limb itching, skin reaction, blister or sore |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefania Fatone, Principle Investigator | Northwestern University | 3125035717 | s-fatone@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 14, 2019 | Dec 26, 2020 | Prot_SAP_000.pdf |
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|
|
| Ischial Containment Socket | Device | 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. |
|
|
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). |
| 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 7 weeks |
| Northwestern University Prosthetics-Orthotics Center |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Scheck and Siress Prosthetics Orthotics | Oakbrook Terrace | Illinois | 60181 | United States |
| Fatone 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. |
| Physician Decision |
|
| NOT COMPLETED |
|
|
Participants wore the NU-FlexSIV Socket for 7 weeks then wore the Ischial Containment Socket for 7 weeks.
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time Since Amputation | Data missing for subjects who withdrew before first data collection session. | Mean | Standard Deviation | years |
|
| Cause of Amputation | Count of Participants | Participants |
|
| K-Level Classification | Rating system used by Medicare to indicate a person's rehabilitation potential. Rating from 0 to 4 indicates a person's potential to use a prosthetic device. K0: no ability/potential. K1: household ambulator. K2: limited community ambulator. K3: community ambulator. K4: exceeds basic ambulation skills. | Count of Participants | Participants |
|
| Amputee Mobility Predictor with Prosthesis | A 21-item performance-based measure of ambulatory potential with a lower limb prosthesis. Scored from 0 to 47, with higher scores indicating better ambulatory ability with prosthesis. | Data missing for subjects who withdrew before first data collection session. | Mean | Standard Deviation | score: 0-47 |
|
| Ischial Containment Socket |
Participants wore the Ischial Containment Socket for 7 weeks |
|
|
|
| Secondary | 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). | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | m/s | 7 weeks |
|
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|
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| Secondary | 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). | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | cm | 7 weeks |
|
|
|
|
| Secondary | 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). | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | degrees | 7 weeks |
|
|
|
|
| Secondary | 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). | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | degrees | 7 weeks |
|
|
|
|
| Secondary | 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). | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | degrees | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | score on a scale | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | seconds | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Deviation | seconds | 7 weeks |
|
|
|
|
| Secondary | 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. | Cross-sectional analysis was conducted with the 19 participants who completed the 7-week data collection visit for this outcome measure for each socket. | Posted | Mean | Standard Error | seconds | 7 weeks |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 14 |
| 25 |
| EG001 | NU-FlexSIV Socket | Participants wore the NU-FlexSIV Socket for 7 weeks. | 0 | 25 | 0 | 25 | 18 | 25 |
|
| fall during testing | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| low back pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| prosthetic foot came loose | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| residual limb volume changes | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| muscle soreness or cramping | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| socket caused pain/discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Vascular |
|
| Infection |
|
| Unknown |
|