Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System

NCT ID: NCT04388488

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2022-01-25

Brief Summary

The primary objective of this investigation is to evaluate how the CONNECT TF compares to traditional handmade sockets, specifically that it provides reliable suspension and improved usability and comfort for the amputee, and that it enables single clinical visit for fitting.

Detailed Description

Design:

This clinical investigation will be of a single group non-randomized open label prospective repeated measures (ABBA) design comparing subject´s current conventional socket and the CONNECT TF. The subjects will be asked to use the CONNECT TF as their primary prosthesis for up to six weeks. Subject will be fitted with the same foot-pylon-knee prosthetic system as used with their current conventional socket, with the CONNECT TF socket.

Procedures:

There are four scheduled study events. At the initial visit, the first study event, for each subject a qualified researcher will obtain an informed consent. Prior to fitting the patient subject to CONNECT TF he/she will be asked to provide feedback and perform tasks on/using their current conventional prosthetic socket. The patient subjects will be fitted with the CONNECT TF within the standard methods of prosthetic fitting, alignment, introduction, training and walking on various terrain.

The CPO (Certified Prosthetis/Orthotist) will conduct the fitting and aligning of the CONNECT TF.

A Co-Investigator will time the fitting procedure; from unpacking the device until it is correctly adjusted and properly fit to the subject.

Data on initial feedback on the device will be collected from the subjects using the instruments specified above. Afterwards an appointment at 2 weeks is made and the subjects leave the clinic on the device.

If the fitting of CONNECT TF fails, i.e. the PI/CPO does not manage to fit the device properly or the subject cannot use the device as intended during training at the clinic, a new appointment is made, if the subject is willing to continue participation.

The second event will be according to the appointment scheduled 2 weeks earlier. During this visit the same set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A 6 week follow up (6WFU) visit is scheduled and the subject leaves on the CONNECT TF socket.

The third event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. A final 6WFU visit is scheduled and the subjects are fitted back to and leave on their current conventional socket.

The fourth event will be according to the appointment scheduled at the previous visit. During this visit set of information will be gathered from/on the subjects as at the initial visit using the conventional socket. End of study.

Data analysis:

The dataset will be assessed with inferential statistics based on the acceptance criteria for the data, as applicable.

Outcomes at each time point will be visually inspected for normality using histograms and qq-plots. If the data are deemed to be normal the hypothesis will be tested using a two-tailed, paired, student's t-test for 2WFU evaluation and mixed models for the 6WFU evaluation. Non-normal data will be tested using the Wilcoxon signed-rank test.

Conditions

Prosthesis User; Amputation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONNECT TF

Trans-femoral amputees currently using a conventional handmade socket will be fitted with the CONNECT TF adaptable socket system for 6 weeks and their current existing conventional socket for 6 weeks, data collection on both sockets will be performed and outcomes compared.

Group Type: EXPERIMENTAL

CONNECT TF adaptable socket system

Intervention Type: DEVICE

Prefabricated, adaptable socket system

Any conventional handmade socket

Intervention Type: DEVICE

Subjects current socket

Interventions

CONNECT TF adaptable socket system

Prefabricated, adaptable socket system

Intervention Type: DEVICE

Any conventional handmade socket

Subjects current socket

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Lower limb amputees
• Uni- or bilateral TF amputees
• 40 < body weight < 125Kg
• Activity level: K1-K2;
• Liner size: 28-45;
• Max 1 user in sizes 28 and 45, respectively
• Residual limb parameters; perineum to distal end: 205 to 280 mm
• Older than 18 years
• Prosthetic users for more than 3 months
• Components of conventional socket functionally compatible to Össur components (foot-pylon-knee combination)
• Users understanding the function of the device
• Willing and able to participate in the study and follow the protocol

Exclusion Criteria

• Other amputees
• 40> body weight > 125Kg
• Amputees with broken skin on the residual limb
• Younger than 18 years
• Prosthetic users for less than 3 months
• Using no liner
• Using a microprocessor controlled prosthetic knee not manufactured by Össur
• Users not understanding the function of the device

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

Össur Iceland ehf

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sashwati Roy, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Eskenazi Health

Indianapolis, Indiana, United States

IU Health Comprehensive Wound Center at Methodist Hospital

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

CIP2020021338

Identifier Type: -

Identifier Source: org_study_id