Clinical trial NCT05190354: Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Official title: Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Prosthesis User
Keywords: transtibial
amputation
prosthesis
below knee
Lead sponsor: Medical Creations, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-13
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.


Eligibility criteria: Inclusion Criteria:

* 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.
* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: User Preference of the Xtremity Socket - Achievement of durability
timeFrame: 21 days
measure: User Preference of the Xtremity Socket - Socket Comfort Score
timeFrame: 21 Days
measure: User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire
timeFrame: 21 Days
measure: User Preference of the Xtremity Socket - Activity
timeFrame: 21 Days
Secondary outcomes:
measure: Benefits to prosthetist - Casting Time
timeFrame: 21 days
measure: Benefits to prosthetist - Material Consumption
timeFrame: 21 days
measure: Benefits to prosthetist - Material Waste
timeFrame: 21 days
measure: Benefits to prosthetist - Resources
timeFrame: 21 days
measure: Benefits to prosthetist - Skill
timeFrame: 21 days
measure: Benefits to prosthetist - Adjustability
timeFrame: 21 days
measure: Benefits to Patient - Mobility
timeFrame: 21 days
measure: Benefits to Patient - Cosmesis
timeFrame: 21 days
measure: Benefits to patient - Number of Visits
timeFrame: 21 days
measure: Device Safety - Composite of Device Related Adverse Events
timeFrame: 21 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Snell Prosthetics and Orthotic Laboratory
state: Arkansas
city: Vancouver
country: Canada
facility: Barber Prosthetics
Study officials:
affiliation: Medical Creations
name: Gary Berke, MS, CP, FAAOP
role: PRINCIPAL_INVESTIGATOR
References: