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Completed
NCT04388488
Connect TF - An Investigation of Function and Usability of a New Adaptable Socket System
Conditions: Prosthesis User, Amputation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 9
Sponsor: Össur Iceland ehf
Location: Eskenazi Health Indianapolis Indiana
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.
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
Source: ClinicalTrials.gov (NCT04388488). StuddyBuddy aggregates publicly available trial information.