AmputationNCT02773056
Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
A study testing Ischial Ramus Containment (IRC), Dynamic Socket Ischial Ramus Containment (IRC) and Sub-Ischial Interface (Sub-I) in people with Amputation, run by University of South Florida at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with… Read more about this study
- Who is it for?
- Ages 18 to 44 years
- Conditions the study is for
- Amputation
- What is being tested?
- Ischial Ramus Containment (IRC), Dynamic Socket Ischial Ramus Containment (IRC) and Sub-Ischial Interface (Sub-I)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unilateral above the knee amputees of non-dysvascular etiology
- 100-275 lbs
- ≥ 1 yr. of prosthetic experience
- Independent community ambulator
- Self-reported ability to walk for 20min consecutively
Who cannot join
- Above the knee amputees of dysvascular etiologies
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Use of an assistive device (i.e. canes, walkers)
- Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
- Known skin issues
- Known cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.
- Conditions
- Amputation
- Being tested
- Ischial Ramus Containment (IRC), Dynamic Socket Ischial Ramus Containment (IRC), Sub-Ischial Interface (Sub-I)
- Keywords
- transfemoral, amputation, perspiration, socket, socket comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischial Ramus Containment (IRC)Device
Ischial Ramus Containment (IRC) is the standard of care socket
Dynamic Socket Ischial Ramus Containment (IRC)Device
Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
Sub-Ischial Interface (Sub-I)Device
Sub-Ischial Interface (Sub-I) is a comparator study socket
| Study group | Role | What they receive |
|---|---|---|
| Socket 1 (Ischial Ramus Containment) | Active comparator | This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket. Receives: Device: Ischial Ramus Containment (IRC) |
| Socket 2 (Dynamic Socket IRC) | Active comparator | This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket. Receives: Device: Dynamic Socket Ischial Ramus Containment (IRC) |
| Socket 3 (Sub-Ischial Interface) | Active comparator | This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket. Receives: Device: Sub-Ischial Interface (Sub-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature
Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Perspiration
Perspiration will be measured by tare weight (grams) following treadmill walking.
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Vertical Interface Movement (Pistoning)
Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Secondary outcomes (3)
Balance and Stability
The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test.
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Comfort
The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets.
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Preference
Patients will be asked which socket they preferred.
Measured: Accommodation with new prosthetic sockets is approximately 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startJun 2016
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Jason Highsmith, PhD, CP, PT, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773056
- Sponsor's protocol ID
- Pro00021886
- Other IDs
- CDMRP-MR140125
- Status last verified
- Mar 2018
- First submitted
- 8 Dec 2015
- Last updated
- 3 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013.
PubMed 33856157
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
- ClinicalTrials.gov ID
- NCT02773056
- Acronym / sponsor ID
- Pro00021886
- Conditions
- Amputation
- Keywords
- transfemoral, amputation, perspiration, socket, socket comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Socket 1 (Ischial Ramus Containment) | Active comparator | Device: Ischial Ramus Containment (IRC)This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket. |
| Socket 2 (Dynamic Socket IRC) | Active comparator | Device: Dynamic Socket Ischial Ramus Containment (IRC)This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket. |
| Socket 3 (Sub-Ischial Interface) | Active comparator | Device: Sub-Ischial Interface (Sub-I)This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Unilateral above the knee amputees of non-dysvascular etiology
- 100-275 lbs
- ≥ 1 yr. of prosthetic experience
- Independent community ambulator
- Self-reported ability to walk for 20min consecutively
Key exclusion criteria (7 listed)
- Above the knee amputees of dysvascular etiologies
- Body weight <100 or >275 lbs
- Does not speak English or Spanish
- Use of an assistive device (i.e. canes, walkers)
- Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees
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 |
|---|---|---|
| Ischial Ramus Containment (IRC)Ischial Ramus Containment (IRC) is the standard of care socket | Device | Socket 1 (Ischial Ramus Containment) |
| Dynamic Socket Ischial Ramus Containment (IRC)Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket | Device | Socket 2 (Dynamic Socket IRC) |
| Sub-Ischial Interface (Sub-I)Sub-Ischial Interface (Sub-I) is a comparator study socket | Device | Socket 3 (Sub-Ischial Interface) |
Primary outcome
Skin Temperature
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed
Perspiration
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Perspiration will be measured by tare weight (grams) following treadmill walking.
Vertical Interface Movement (Pistoning)
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.
3 secondary outcomes
Balance and Stability
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Comfort
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Preference
Time frame: Accommodation with new prosthetic sockets is approximately 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Derived from this study: PubMed 33856157Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013.
- Individual participant dataSharing planned: Yes
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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.
Jason Highsmith, PhD, CP, PT principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischial Ramus Containment (IRC), Dynamic Socket Ischial Ramus Containment (IRC) and Sub-Ischial Interface (Sub-I) in people with Amputation, run by University of South Florida 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 5 inclusion and 7 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 3 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Temperature (time frame: Accommodation with new prosthetic sockets is approximately 10 days). The study lists 3 primary outcomes in all. 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 NCT02773056, which also lists 1 linked publication.
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 3 Apr 2018.