Status:
COMPLETED
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
Lead Sponsor:
Össur Iceland ehf
Collaborating Sponsors:
Indiana University
Conditions:
Prosthesis User
Amputation
Eligibility:
All Genders
18+ years
Phase:
NA
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 com...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04388488
Start Date
August 3 2020
End Date
January 25 2022
Last Update
October 8 2024
Active Locations (2)
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1
Eskenazi Health
Indianapolis, Indiana, United States, 46202
2
IU Health Comprehensive Wound Center at Methodist Hospital
Indianapolis, Indiana, United States, 46206-1367