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

Amputation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773056
• Other study ID #: Pro00021886
• Secondary ID: CDMRP-MR140125
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: March 30, 2018
• Start date: June 2016
• Est. completion date: March 30, 2018

Study information

• Verified date: March 2018
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 30, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• Unilateral above the knee amputees of non-dysvascular etiology

• 100-275 lbs

• = 1 yr. of prosthetic experience

• Independent community ambulator

• Self-reported ability to walk for 20min consecutively

Exclusion Criteria:

• Above the knee amputees of dysvascular etiologies

• Body weight <100 or >275 lbs

• Does not speak English or Spanish

• Use of an assistive device (i.e. canes, walkers)

• Transtibial, hip disarticulation, hemipelvectomy, partial foot and bilateral amputees

• Known skin issues

• Known cognitive impairment

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Ischial Ramus Containment (IRC)
Ischial Ramus Containment (IRC) is the standard of care socket
• Dynamic Socket Ischial Ramus Containment (IRC)
Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
• Sub-Ischial Interface (Sub-I)
Sub-Ischial Interface (Sub-I) is a comparator study socket

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin Temperature	Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed	Accommodation with new prosthetic sockets is approximately 10 days
Primary	Perspiration	Perspiration will be measured by tare weight (grams) following treadmill walking.	Accommodation with new prosthetic sockets is approximately 10 days
Primary	Vertical Interface Movement (Pistoning)	Pistoning will be defined as the numerical difference of interface to skeletal movement (cm) between simulated swing (lifting the prosthetic side) and stance (single support on the prosthetic side) as measured by coronal X-Ray.	Accommodation with new prosthetic sockets is approximately 10 days
Secondary	Balance and Stability	The gold standard test of standing balance is the sensory organization test (SOT) administered on the Neurocom Equitest platform. The SOT score is a unitless number. Subjects stand on a pair of platforms that record force data and tilt in the sagittal plane during 6 varying conditions that challenge the visual, vestibular and somatosensory systems. With compromised ability to use an ankle strategy for balance, a hip strategy is routinely adopted, therefore higher interface trim lines could adversely affect performance on this test.	Accommodation with new prosthetic sockets is approximately 10 days
Secondary	Comfort	The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets.	Accommodation with new prosthetic sockets is approximately 10 days
Secondary	Preference	Patients will be asked which socket they preferred.	Accommodation with new prosthetic sockets is approximately 10 days