Traumatic AmputeePOPNCT02720159
Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
A study testing Percutaneous Osseintegrated Prosthesis in people with Traumatic Amputee, run by Encore Medical, L.P. at 1 site in United States.
Trial summary
The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Amputee
- What is being tested?
- Percutaneous Osseintegrated Prosthesis
- 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
- Dec 2015to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- US Military veteran with transfemoral amputation that is not a result of dysvascular disease
- Has used or is using a "socket suspension technology" prosthesis
- Use of non-propulsive, passive microprocessor-regulated devices
- Agrees not to participate in high levels of physical activity while in the study
- Subject meets anatomical and eligibility criteria for the investigational device
Who cannot join
- Currently on active military duty
- More than 1 limb amputated
- Has insulin dependent or adult onset diabetes
- Recent tobacco use
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148
Sarina Sinclair, PhD, 801-582-1565, sarina.sinclair@va.gov
Erik Kubiak, MD
About this study
Official title: A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis
The purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.
- Conditions
- Traumatic Amputee
- Being tested
- Percutaneous Osseintegrated Prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Osseintegrated ProsthesisDevice
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT | Experimental | Not described Receives: Device: Percutaneous Osseintegrated Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant
Measured: 1 year
Changes in Bone Mineral Density as collected using DEXA scan
Measured: 1 year
Changes in implant exit site using Modified Holgers Skin Metric
Measured: 1 yr
Analyze measurable changes in the stoma punch
Measured: 1 year
Analyze changes of walking and standing
Three dimensional motion capture of walking and standing through a calibration volume that contains force plates
Measured: 1 year
Analyze changes in metabolic efficiency
Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.
Measured: 1 year
Analyze changes in 6 minute walk test
Measured: 1 year
Assess changes in Donning and Doffing prosthetic time
Measured: 1 year
Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test
Measured: 1 year
Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions
Measured: 1 yr
Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)
Measured: 1 yr
Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions
Measured: 1 yr
Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function
Measured: 1 yr
Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting
Measured: 1 yr
Changes in at-home prosthetic usage using StepWatch activity monitor
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
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 Traumatic AmputeeStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VA Salt Lake City Health Care System
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720159
- Sponsor's protocol ID
- POP
- Acronym
- POP
- Status last verified
- Mar 2016
- First submitted
- 8 Mar 2016
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sinclair S, Beck JP, Webster J, Agarwal J, Gillespie B, Stevens P, Gililland J, Kubiak E. The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2092-2104. doi: 10.1016/j.apmr.2022.06.008. Epub 2022 Jul 29.
PubMed 35908658
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis
- ClinicalTrials.gov ID
- NCT02720159
- Acronym / sponsor ID
- POP / POP
- Conditions
- Traumatic Amputee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- VA Salt Lake City Health Care System
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 25 Mar 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 purpose of the clinical study is to characterize the efficacy and safety of a Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal seal, thus allowing a proper biobarrier around the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TREATMENT | Experimental | Device: Percutaneous Osseintegrated Prosthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- US Military veteran with transfemoral amputation that is not a result of dysvascular disease
- Has used or is using a "socket suspension technology" prosthesis
- Use of non-propulsive, passive microprocessor-regulated devices
- Agrees not to participate in high levels of physical activity while in the study
- Subject meets anatomical and eligibility criteria for the investigational device
Key exclusion criteria (4 listed)
- Currently on active military duty
- More than 1 limb amputated
- Has insulin dependent or adult onset diabetes
- Recent tobacco use
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 |
|---|---|---|
| Percutaneous Osseintegrated Prosthesis | Device | TREATMENT |
Primary outcome
Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant
Time frame: 1 year
Changes in Bone Mineral Density as collected using DEXA scan
Time frame: 1 year
Changes in implant exit site using Modified Holgers Skin Metric
Time frame: 1 yr
Analyze measurable changes in the stoma punch
Time frame: 1 year
Analyze changes of walking and standing
Time frame: 1 year
Three dimensional motion capture of walking and standing through a calibration volume that contains force plates
Analyze changes in metabolic efficiency
Time frame: 1 year
Measure CO2 and O2 exhaled, total energy cost for walking at slow, normal, fast; self-selected and/or fixed speeds while wearing a two-way valve.
Analyze changes in 6 minute walk test
Time frame: 1 year
Assess changes in Donning and Doffing prosthetic time
Time frame: 1 year
Assess changes in Comprehensive High-Level Activity Mobility Predictor (CHAMP) test
Time frame: 1 year
Changes in psychosocial adjustment with the Trinity Amputation and Prosthesis Experience Scales - Revised (TAPES-R) Part I, 37 questions
Time frame: 1 yr
Changes in depressive symptomatology using the Center for Epidemiologic Studies Depression Scale Revisited (CES-D)
Time frame: 1 yr
Changes in consequences of pain on relevant aspects of persons' lives using PROMIS: Pain Interference questions
Time frame: 1 yr
Changes in ability to carry out activities that require physical actions using PROMIS: Physical Function
Time frame: 1 yr
Changes in overall quality of life using QOL Visual Analog Scale, no numerical weighting
Time frame: 1 yr
Changes in at-home prosthetic usage using StepWatch activity monitor
Time frame: 1 yr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- Derived from this study: PubMed 35908658Sinclair S, Beck JP, Webster J, Agarwal J, Gillespie B, Stevens P, Gililland J, Kubiak E. The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2092-2104. doi: 10.1016/j.apmr.2022.06.008. Epub 2022 Jul 29.
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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.
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Osseintegrated Prosthesis in people with Traumatic Amputee, run by Encore Medical, L.P. 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: status not confirmed, as of the sponsor's last update on 25 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess AP & Lateral x-rays for osteolysis, radioulucencies indicative of component moevent and orientation and stress shielding or bone remodeling around the implant (time frame: 1 year). The study lists 15 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 NCT02720159, 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 25 Mar 2016.