Socket Designs of Transfemoral Amputees.Phase 3NCT01416129
Southern Bone & Joint Study - Brimless Sockets
A Phase 3 study testing Prosthetic brimless socket in people with Socket Designs of Transfemoral Amputees., run by University of South Florida at 1 site in United States.
Trial summary
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Designs of Transfemoral Amputees.
- What is being tested?
- Prosthetic brimless socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Oct 2011
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Be able to independently provide informed consent
- Be willing to comply with study procedures.
Who cannot join
- History of chronic skin breakdown on the residual limb
- Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- Unwillingness/inability to follow instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
- Conditions
- Socket Designs of Transfemoral Amputees.
- Being tested
- Standard of care socket, Prosthetic brimless socket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care socketDevice
Amputees' preferred socket.
Prosthetic brimless socketDevice
Study socket
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Prosthetic socket standard of care | Active comparator | Not described Receives: Device: Standard of care socket |
| Active Comparator: Prosthetic brimless socket | Active comparator | Not described Receives: Device: Prosthetic brimless socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Balance and Stability
Balance and stability will be assessed for limits of stability and postural stability.
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Quality of Life
Validated surveys will be used to solicit participants' subjective experience and feedback.
Measured: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Socket Pressure
Pressure sensors are placed on the skin and measured.
Measured: 10 minutes after fitting with both sockets
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionOct 2011
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 Socket Designs of Transfemoral Amputees.Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Bone & Joint Specialists, P.A.
- Responsible party
- Sponsor
- Investigators
- Jason Highsmith, PT,DPT,CP, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01416129
- Sponsor's protocol ID
- 6140101600
- Status last verified
- May 2014
- First submitted
- 11 Aug 2011
- Last updated
- 2 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Superiority of Brimless Versus Ischial Ramus Containment (IRC) Sub Atmospheric Transfemoral Interfaces
- ClinicalTrials.gov ID
- NCT01416129
- Acronym / sponsor ID
- 6140101600
- Conditions
- Socket Designs of Transfemoral Amputees.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Southern Bone & Joint Specialists, P.A.
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 12 Aug 2011 (estimated)
- Results
- Posted 2 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Prosthetic socket standard of care | Active comparator | Device: Standard of care socket |
| Active Comparator: Prosthetic brimless socket | Active comparator | Device: Prosthetic brimless socket |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Unilateral transfemoral or knee-disarticulation amputee
- 18 to 85 years of age
- K3 (variable cadence and community) ambulators;
- Be able to independently provide informed consent
- Be willing to comply with study procedures.
Key exclusion criteria (4 listed)
- History of chronic skin breakdown on the residual limb
- Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
- Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
- Unwillingness/inability to follow instructions
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 |
|---|---|---|
| Standard of care socketAmputees' preferred socket. | Device | Active Comparator: Prosthetic socket standard of care |
| Prosthetic brimless socketStudy socket | Device | Active Comparator: Prosthetic brimless socket |
Primary outcome
Gait
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Gait will be assessed in terms of biomechanics and spatiotemporal parameters.
Balance and Stability
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Balance and stability will be assessed for limits of stability and postural stability.
Quality of Life
Time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.
Validated surveys will be used to solicit participants' subjective experience and feedback.
Socket Pressure
Time frame: 10 minutes after fitting with both sockets
Pressure sensors are placed on the skin and measured.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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, PT,DPT,CP 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 Phase 3 study testing Prosthetic brimless socket in people with Socket Designs of Transfemoral Amputees., 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 4 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 2 Jun 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jun 2014). 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?
Gait (time frame: Based on preliminary experience with the intervention, accommodation can range from 2 weeks to 3 months. Assessment will be scheduled within 2 weeks following accommodation.). The study lists 4 primary outcomes in all. 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 2 Jun 2014.