Unilateral Transfemoral AmputationNCT07768072
A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions
An observational study of Unilateral Transfemoral Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Transfemoral Amputation
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.
Who may be able to join
- For all participants:
- Ability to complete the experimental protocol without undue fatigue or health risks
- Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)
- In addition for persons with lower limb amputation:
- Prosthesis user for a minimum of 2 years with their current socket design
- Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
- Good skin integrity on their residual limb upon visual inspection
- Does not require the use of assistive devices to walk
Who cannot join
- Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
- Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
Rebecca Stine, MS, (312) 503-5726, rebecca.stine@va.gov
Steven A Gard, PhD, (312) 503-5718, steven.gard@va.gov
About this study
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.
Read the detailed description
The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.
The specific aims and hypotheses of this project are:
Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.
Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.
Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.
- Conditions
- Unilateral Transfemoral Amputation
- Keywords
- transfemoral amputation, prosthetic socket design, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ischial Containment Socket user | Person with unilateral transfemoral amputation wearing an ischial containment socket | |
| Sub-Ischial Socket user | Person with unilateral transfemoral amputation wearing a sub-ischial socket | |
| Able-bodied control | Person without an amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Secondary outcomes (5)
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
EMG activity will be assessed using surface electrodes attached bilaterally to the erector spinae at and below T12/L1 and on the external oblique muscle. Data will be collected during the quantitative motion analysis.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Lumbar flexion will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Hip Joint ROM will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate hip joint ROM.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Dynamic LLD will be calculated for all participants during the walking trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculated dynamic LLD.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Lumbar joint loading during walking will be analyzed by performing musculoskeletal modeling simulations using data collected during the quantitative motion analysis.
Measured: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Transfemoral AmputationStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Rebecca Stine, MS, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07768072
- Sponsor's protocol ID
- RRD2-014-25W
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Ischial-Containment and Sub-Ischial Prosthetic Sockets to Determine Their Effects on Secondary Health Conditions
- ClinicalTrials.gov ID
- NCT07768072
- Acronym / sponsor ID
- RRD2-014-25W
- Conditions
- Unilateral Transfemoral Amputation
- Keywords
- transfemoral amputation, prosthetic socket design, low back pain
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Aug 2026 (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.
Long-term above-knee prosthesis users are at an increased risk of developing secondary musculoskeletal conditions compared to the general able-bodied population. One secondary physical concern is low back pain (LBP), for which the development is not entirely understood, but in above-knee prosthesis users it is believed to relate to asymmetries and compensations that are typically demonstrated and required to stand and walk. Understanding spinal motion and compensations will enhance our knowledge of the factors contributing to LBP, and possibly lead to the development of new prosthetic and therapeutic interventions to prevent or alleviate LBP, thereby improving mobility and quality of life for prosthesis users.
Detailed description
The purpose of this study is to investigate and compare the effects of the standard ischial containment (IC) socket to a sub-ischial (SI) socket design on the spinal and pelvic motions and leg length (LLD) discrepancies of transfemoral prosthesis users. Data will be collected from 2 groups of transfemoral prosthesis users (15 SI socket wearers and 15 IC socket wearers) and a group of 15 able-bodied (AB) control participants. Gait and standing analyses will be conducted on each participant using a marker based motion capture system. Prosthesis users will wear their own conventional sockets for the gait and standing analyses. Kinematic and kinetic data will be analyzed for differences between the 2 groups of socket wearers and will also be compared to the control group.
The specific aims and hypotheses of this project are:
Aim 1: To measure dynamic leg length and kinematics of the pelvis and spinal segments in unilateral, transfemoral prosthesis users during gait. Quantitative motion analyses will be performed on two groups of 15 research participants with lower limb amputation using 2 different socket designs (IC and SI) walking over level ground at three self-selected walking speeds (normal, moderately fast, fastest). Data will be compared between socket type and to an AB control group. Hypothesis 1a-IC socket wearers will have a greater anterior pelvic tilt compared to SI socket wearers and AB controls, and they will exhibit considerably greater rotations of the pelvis and spinal segments during walking. Hypothesis 1b-The EMG activity of the lumbar erector spinae for SI socket users will better approximate the patterns of AB controls as compared to IC socket wearers. Hypothesis 1c-The dynamic LLD will be greater for IC socket users compared to SI socket wearers and AB controls.
Aim 2: To measure pelvic orientation and static leg length in unilateral, transfemoral prosthesis users during standing. A multi-segment model of the spine and pelvis will be used to determine neutral spinal, pelvis, and prosthetic alignment during standing for the research and AB control participants. Hypothesis 2a-IC socket wearers will demonstrate greater anterior pelvic tilt during standing compared to SI socket wearers and control participants. Hypothesis 2b-The prosthetic and sound leg lengths for both prosthesis user groups will be within 1.0 cm of each other during standing.
Aim 3: To estimate joint contact forces in the legs and lower back of unilateral, transfemoral prosthesis users and controls during gait. Computational musculoskeletal simulations will be used to comprehensively evaluate the data from Aim 1 to compare the lumbar joint loads between IC and SI socket wearers. Hypothesis 3-IC socket wearers will exhibit greater lumbar joint loads than SI socket wearers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischial Containment Socket user | – | –Person with unilateral transfemoral amputation wearing an ischial containment socket |
| Sub-Ischial Socket user | – | –Person with unilateral transfemoral amputation wearing a sub-ischial socket |
| Able-bodied control | – | –Person without an amputation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty unilateral transfemoral prosthesis users (15 with an ischial containment socket and 15 with a sub-ischial socket) and 15 able-bodied control participants.
Key inclusion criteria (8 listed)
- Ability to complete the experimental protocol without undue fatigue or health risks
- Low Back Pain scale assessment (0-10) less than 4 (activities of daily living or quality of life not impacted)
- Prosthesis user for a minimum of 2 years with their current socket design
- Good fit with either an ischial containment (IC) or sub-ischial (SI) socket
- Good skin integrity on their residual limb upon visual inspection
Key exclusion criteria (2 listed)
- Previously diagnosed with a spine condition (e.g., pinched nerve, bulging disc, etc.)
- Previously diagnosed with an orthopedic or neuromuscular condition that may affect walking or balance (e.g., ankle fusion, Parkinson's disease, stroke, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Anterior Pelvic Tilt will be calculated for all participants during the walking and standing trials. Participants will walk along a 10 meter walkway at varying speeds. Quantitative motion analysis using a marker based motion measurement system will be used to calculate anterior pelvic tilt.
5 secondary outcomes
Electromyography (EMG) Activity of the Lumbar Erector Spinae Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Lumbar Flexion Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Hip Joint Range of Motion (ROM) between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Dynamic Leg Length Discrepancy (LLD) Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Peak Lumbar Joint Loading Between the IC Socket wearers and the SI Socket wearers/Able-bodied Controls
Time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Unilateral Transfemoral Amputation
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Impact of Anterior Load Carriage on Gait in Individuals With Transfemoral Amputation
Unilateral Transfemoral Amputation in Prosthetic Users
Recruiting
The Analgesic Efficacy of Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Ultrasound Guided Peripheral Nerve Blocks as a Solo Anesthetic Technique in High Risk Patients Undergoing Unilateral Above Knee Amputation .
Analgesia Assessment, Above Knee Amputation
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Real-time Motion Capture and Visual Feedback for Amputation Gait Training
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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.
Rebecca Stine, MS principal investigator
Jesse Brown VA Medical Center, Chicago, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral Transfemoral Amputation, run by VA Office of Research and Development at 1 site 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 8 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Stine, MS ((312) 503-5726, rebecca.stine@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Pelvic Tilt Angle Between the IC Socket wearers and the SI Socket wearers/Able-Bodied Controls (time frame: To be measured on day 1 of the single study visit, within an estimated 3-hour timeframe). 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 17 Aug 2026.