NCT02773056

Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this clinical trial is to determine if the Dynamic Socket and Sub-Ischial alternative interface designs improve socket comfort, residual limb health, increase function and be preferred over the standard of care Ischial Ramus Containment (IRC) interface for the military and veteran living with transfemoral limb loss.

Conditions

• Amputation

Interventions

Type	Name	Description
DEVICE	Ischial Ramus Containment (IRC)	Ischial Ramus Containment (IRC) is the standard of care socket
DEVICE	Dynamic Socket Ischial Ramus Containment (IRC)	Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
DEVICE	Sub-Ischial Interface (Sub-I)	Sub-Ischial Interface (Sub-I) is a comparator study socket

Timeline

• Start date: 2016-06-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2016-05-16
• Last updated: 2018-04-03

Locations

1 site across 1 country: United States