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

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)