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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04388488). StuddyBuddy aggregates publicly available trial information.