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

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Ischial Ramus Containment (IRC); Device: Dynamic Socket Ischial Ramus Containment (IRC); Device: Sub-Ischial Interface (Sub-I)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Perspiration	Perspiration will be measured by tare weight (grams) following treadmill walking.	Accommodation with new prosthetic sockets is approximately 10 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Preference	Patients will be asked which socket they preferred.	Accommodation with new prosthetic sockets is approximately 10 days

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Jason Highsmith, PhD, CP, PT, University of South Florida

Publications and helpful links

General Publications

• Kahle JT, Miro RM, Ho LT, Porter MR, Lura DJ, Carey SL, Lunseth P, Swanson AE, Highsmith MJ. Effect of transfemoral prosthetic socket interface design on gait, balance, mobility, and preference: A randomized clinical trial. Prosthet Orthot Int. 2021 Aug 1;45(4):304-312. doi: 10.1097/PXR.0000000000000013.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): March 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 16, 2016

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 30, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: amputation; perspiration; socket; socket comfort; transfemoral
• Other Study ID Numbers: Pro00021886; CDMRP-MR140125 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes