Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Amputation Clinical Trial

Official title:

Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05190354
• Other study ID #: CP-0001
• Status: Completed
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: June 24, 2022

Study information

• Verified date: August 2022
• Source: Medical Creations, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 24, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation
• Prosthesis User

Intervention

Device:
• Xtremity Polymer Prosthetic Socket
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

Locations

Country	Name	City	State
Canada	Barber Prosthetics	Vancouver
United States	Snell Prosthetics and Orthotic Laboratory	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Medical Creations, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Preference of the Xtremity Socket - Achievement of durability	Device success defined as rate of achieving durability	21 days
Primary	User Preference of the Xtremity Socket - Socket Comfort Score	Rate of device success measured by Socket Comfort Score	21 Days
Primary	User Preference of the Xtremity Socket - Prosthetic Evaluation Questionnaire	Rate of device success measured by abbreviated Prosthetic Evaluation Questionnaire	21 Days
Primary	User Preference of the Xtremity Socket - Activity	Rate of device success measured by activity level ranked low activity to high activity (1-10)	21 Days
Secondary	Benefits to prosthetist - Casting Time	Measured by time from casting to delivery in days	21 days
Secondary	Benefits to prosthetist - Material Consumption	Measured by amount of material consumed	21 days
Secondary	Benefits to prosthetist - Material Waste	Measured by amount of material wasted	21 days
Secondary	Benefits to prosthetist - Resources	Number of resources required to use	21 days
Secondary	Benefits to prosthetist - Skill	Level of skill set required to use ranked on a scale from very easy to very difficult (1-5)	21 days
Secondary	Benefits to prosthetist - Adjustability	Ease of adjustability ranked from difficult to easy (1-5)	21 days
Secondary	Benefits to Patient - Mobility	Measured by Amputee Mobility Predictor Assessment Tool	21 days
Secondary	Benefits to Patient - Cosmesis	Measured by Cosmesis survey question ranked from very unattractive to very attractive (1-5)	21 days
Secondary	Benefits to patient - Number of Visits	Measured as number of visits to achieve adequate fit in days	21 days
Secondary	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.	21 days