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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773056


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

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02773056     History of Changes
Other Study ID Numbers: Pro00021886
CDMRP-MR140125 ( Other Grant/Funding Number: Department of Defense )
First Posted: May 16, 2016    Key Record Dates
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