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

University of South Florida logo

University of South Florida

Status

Completed

Conditions

Amputation

Treatments

Device: Ischial Ramus Containment (IRC)
Device: Sub-Ischial Interface (Sub-I)
Device: Dynamic Socket Ischial Ramus Containment (IRC)

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT02773056
CDMRP-MR140125 (Other Grant/Funding Number)
Pro00021886

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 44 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

15 participants in 3 patient groups

Socket 1 (Ischial Ramus Containment)
Active Comparator group
Description:
This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket.
Treatment:
Device: Ischial Ramus Containment (IRC)
Socket 2 (Dynamic Socket IRC)
Active Comparator group
Description:
This arm included unilateral transfemoral amputees who were assessed while using the Dynamic Socket Ischial Ramus Containment socket.
Treatment:
Device: Dynamic Socket Ischial Ramus Containment (IRC)
Socket 3 (Sub-Ischial Interface)
Active Comparator group
Description:
This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.
Treatment:
Device: Sub-Ischial Interface (Sub-I)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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