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

Completed · Not applicable

Conditions studied: Prosthesis User, Amputation

In brief

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.

Key facts

Study ID

NCT04388488

Run by

Össur Iceland ehf

People needed

9

Starts

2020-08-03

Expected to finish

2022-01-25

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Eskenazi Health — Indianapolis, Indiana, United States
• IU Health Comprehensive Wound Center at Methodist Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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