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

• ClinicalTrials.gov Identifier: NCT02773056
• Recruitment Status: Completed
• First Posted: May 16, 2016
• Last Update Posted: April 3, 2018
• Sponsor: University of South Florida
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): University of South Florida

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Amputation	Device: Ischial Ramus Containment (IRC); Device: Dynamic Socket Ischial Ramus Containment (IRC); Device: Sub-Ischial Interface (Sub-I)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Prosthetic Socket Interface Design on Socket Comfort, Residual Limb Health, and Function for the Transfemoral Amputee
• Actual Study Start Date: June 2016
• Actual Primary Completion Date: March 30, 2018
• Actual Study Completion Date: March 30, 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Socket 1 (Ischial Ramus Containment); This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket.	Device: Ischial Ramus Containment (IRC); Ischial Ramus Containment (IRC) is the standard of care socket
Active Comparator: Socket 2 (Dynamic Socket IRC); This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket.	Device: Dynamic Socket Ischial Ramus Containment (IRC); Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
Active Comparator: Socket 3 (Sub-Ischial Interface); This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.	Device: Sub-Ischial Interface (Sub-I); Sub-Ischial Interface (Sub-I) is a comparator study socket

Outcome Measures

Primary Outcome Measures :

1. Skin Temperature [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   Continuous skin temperature measurement (Celsius) will be taken during treadmill walking at self-selected comfortable speed
2. Perspiration [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   Perspiration will be measured by tare weight (grams) following treadmill walking.
3. Vertical Interface Movement (Pistoning) [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   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.

Secondary Outcome Measures :

1. Balance and Stability [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   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.
2. Comfort [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   The Socket Comfort Score (rated on an 11-point 0-10 scale) will be used to assess patients' comfort in the respective sockets.
3. Preference [ Time Frame: Accommodation with new prosthetic sockets is approximately 10 days ]
   Patients will be asked which socket they preferred.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 44 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Florida

University of South Florida

Tampa, Florida, United States, 33612

Sponsors and Collaborators

University of South Florida

United States Department of Defense

Investigators

• Principal Investigator: Jason Highsmith, PhD, CP, PT; University of South Florida

More Information

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT02773056
• Other Study ID Numbers: Pro00021886; CDMRP-MR140125 ( Other Grant/Funding Number: Department of Defense )
• First Posted: May 16, 2016
• Last Update Posted: April 3, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by University of South Florida:

transfemoral; amputation; perspiration; socket; socket comfort