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OpenTrials
Completed

NCT Number: NCT02773056

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.

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Key information

Conditions

Amputation

Age range

18 year–44 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ischial Ramus Containment (IRC)

Device

Ischial Ramus Containment (IRC) is the standard of care socket

Dynamic Socket Ischial Ramus Containment (IRC)

Device

Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket

Sub-Ischial Interface (Sub-I)

Device

Sub-Ischial Interface (Sub-I) is a comparator study socket

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • United States Department of Defense

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 16, 2016
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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