AmputationNCT05190354
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
A study testing Xtremity Polymer Prosthetic Socket in people with Amputation and Prosthesis User, run by Medical Creations, Inc. at 2 sites in 2 countries.
Trial summary
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Amputation, Prosthesis User
- What is being tested?
- Xtremity Polymer Prosthetic Socket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Nov 2021to 24 Jun 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 19 years old
- Unilateral or bilateral transtibial amputation
- Subject has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
- Currently using a standard carbon fiber or high temperature thermoplastic prosthetic socket.
- Residual limb is between 26-34 cm circumference with a liner (when measured 4cm proximal to distal end)
- Subject is eligible for standard carbon fiber or high temperature thermoplastic prosthetic socket if necessary.
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- Must be able to ambulate at least 100 yards with or without an assistive device.
- Must be able to don and doff a prosthesis independently.
- Estimated life expectancy > 1 year
Who cannot join
- Amputation < 6 months prior to enrollment
- Residual limb less than (<) 26cm and greater than (>) 34cm circumference at the distal end.
- Body weight greater than (>) 275lbs.
- Syme's amputations or total limb length over 30cm
- Some bulbous or irregular limb shapes
- Build height and circumference limitations
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- Wounds or skin issues that preclude normal fit
- Unusual alignment of the socket or foot
- Alignment outside the capability of the Xtremity System.
- Planned for any major surgery within 6 months of enrollment.
- Subject is pregnant or breastfeeding
- Subject is incarcerated.
- Subject anticipates that the socket will frequently be subject to temperatures greater than 110 degrees F while in their possession.
- Subject anticipates that the socket will frequently be subject to direct sunlight
- Limb circumference at the mid-patella tendon exceeds the maximum circumference (see sizing chart in the instructions for use)
- Subject is participating in another research study of a device, medication, which could, in the opinion of the investigator, affect the results of this study.
- Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and or participating in evaluations pre and post-treatment.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Snell Prosthetics and Orthotic Laboratory
Little Rock, Arkansas, 72205
About this study
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
- Conditions
- Amputation, Prosthesis User
- Being tested
- Xtremity Polymer Prosthetic Socket
- Keywords
- transtibial, amputation, prosthesis, below knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xtremity Polymer Prosthetic SocketDevice
Subjects with transtibial unilateral or bilateral amputation who have experience using a standard carbon fiber or high temperature thermoplastic prosthetic socket will be evaluated and fitted with a below knee prosthesis socket
| Study group | Role | What they receive |
|---|---|---|
| Xtremity Prosthesis | Experimental | Xtremity Prosthesis fitting Receives: Device: Xtremity Polymer Prosthetic Socket |
What is being measured
The primary outcome is the main question the study is designed to answer.
User Preference of the Xtremity Socket - Achievement of durability
Device success defined as rate of achieving durability
Measured: 21 days
User Preference of the Xtremity Socket - Socket Comfort Score
Rate of device success measured by Socket Comfort Score
Measured: 21 Days
User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire
Measured: 21 Days
User Preference of the Xtremity Socket - Activity
Rate of device success measured by activity level ranked low activity to high activity (1-10)
Measured: 21 Days
Secondary outcomes (10)
Benefits to prosthetist - Casting Time
Measured by time from casting to delivery in days
Measured: 21 days
Benefits to prosthetist - Material Consumption
Measured by amount of material consumed
Measured: 21 days
Benefits to prosthetist - Material Waste
Measured by amount of material wasted
Measured: 21 days
Benefits to prosthetist - Resources
Number of resources required to use
Measured: 21 days
Benefits to prosthetist - Skill
Level of skill set required to use ranked on a scale from very easy to very difficult (1-5)
Measured: 21 days
Benefits to prosthetist - Adjustability
Ease of adjustability ranked from difficult to easy (1-5)
Measured: 21 days
Benefits to Patient - Mobility
Measured by Amputee Mobility Predictor Assessment Tool
Measured: 21 days
Benefits to Patient - Cosmesis
Measured by Cosmesis survey question ranked from very unattractive to very attractive (1-5)
Measured: 21 days
Benefits to patient - Number of Visits
Measured as number of visits to achieve adequate fit in days
Measured: 21 days
Device Safety - Composite of Device Related Adverse Events
Composite of device related Adverse Events (DAE) assessed throughout 21 days after prosthetic fitting. DAE is defined as a composite of all cause death, socket site skin problems that prevent wearing a prosthetic, socket site infection, and falls due to socket malfunction that result in injury.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start16 Nov 2021
- Primary completion11 May 2022
- Study completion24 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects with transtibial unilateral or bilateral amputation who have experience using carbon fiber or high temperature thermoplastic prosthetic socket and are at least 6-months post-amputation.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Creations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Berke, MS, CP, FAAOP, Principal investigator, Medical Creations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190354
- Sponsor's protocol ID
- CP-0001
- Status last verified
- Aug 2022
- First submitted
- 6 Dec 2021
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
- ClinicalTrials.gov ID
- NCT05190354
- Acronym / sponsor ID
- CP-0001
- Conditions
- Amputation, Prosthesis User
- Keywords
- transtibial, amputation, prosthesis, below knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical Creations, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Nov 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 13 Jan 2022 (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.
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with transtibial unilateral or bilateral amputation who have experience using carbon fiber or high temperature thermoplastic prosthetic socket and are at least 6-months post-amputation.
| Arm | Type | Receives |
|---|---|---|
| Xtremity Prosthesis | Experimental | Device: Xtremity Polymer Prosthetic SocketXtremity Prosthesis fitting |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥ 19 years old
- Unilateral or bilateral transtibial amputation
- Subject has been informed of the nature of the study, agrees to participate and comply with all follow-up visits and has signed the consent form.
- Currently using a standard carbon fiber or high temperature thermoplastic prosthetic socket.
- Residual limb is between 26-34 cm circumference with a liner (when measured 4cm proximal to distal end)
Key exclusion criteria (17 listed)
- Amputation < 6 months prior to enrollment
- Residual limb less than (<) 26cm and greater than (>) 34cm circumference at the distal end.
- Body weight greater than (>) 275lbs.
- Syme's amputations or total limb length over 30cm
- Some bulbous or irregular limb shapes
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 |
|---|---|---|
| Xtremity Polymer Prosthetic SocketSubjects with transtibial unilateral or bilateral amputation who have experience using a standard carbon fiber or high temperature thermoplastic prosthetic socket will be evaluated and fitted with a below knee prosthesis socket | Device | Xtremity Prosthesis |
Primary outcome
User Preference of the Xtremity Socket - Achievement of durability
Time frame: 21 days
Device success defined as rate of achieving durability
User Preference of the Xtremity Socket - Socket Comfort Score
Time frame: 21 Days
Rate of device success measured by Socket Comfort Score
User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
Time frame: 21 Days
Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire
User Preference of the Xtremity Socket - Activity
Time frame: 21 Days
Rate of device success measured by activity level ranked low activity to high activity (1-10)
10 secondary outcomes
Benefits to prosthetist - Casting Time
Time frame: 21 days
Benefits to prosthetist - Material Consumption
Time frame: 21 days
Benefits to prosthetist - Material Waste
Time frame: 21 days
Benefits to prosthetist - Resources
Time frame: 21 days
Benefits to prosthetist - Skill
Time frame: 21 days
Benefits to prosthetist - Adjustability
Time frame: 21 days
Benefits to Patient - Mobility
Time frame: 21 days
Benefits to Patient - Cosmesis
Time frame: 21 days
Benefits to patient - Number of Visits
Time frame: 21 days
Device Safety - Composite of Device Related Adverse Events
Time frame: 21 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 24 Aug 2022.
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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.
Gary Berke, MS, CP, FAAOP principal investigator
Medical Creations
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xtremity Polymer Prosthetic Socket in people with Amputation and Prosthesis User, run by Medical Creations, Inc. at 2 sites in 2 countries.
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 9 inclusion and 17 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 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
User Preference of the Xtremity Socket - Achievement of durability (time frame: 21 days). 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 24 Aug 2022.