NCT02773056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

1.8 years

First QC Date

December 8, 2015

Last Update Submit

March 30, 2018

Conditions

Amputation

Keywords

transfemoralamputationperspirationsocketsocket comfort

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Balance and Stability

    Accommodation with new prosthetic sockets is approximately 10 days

  • Comfort

    Accommodation with new prosthetic sockets is approximately 10 days

  • Preference

    Accommodation with new prosthetic sockets is approximately 10 days

Study Arms (3)

Socket 1 (Ischial Ramus Containment)

ACTIVE COMPARATOR

This arm included unilateral transfemoral amputees who were assessed while using the Ischial Ramus Containment socket.

Device: Ischial Ramus Containment (IRC)

Socket 2 (Dynamic Socket IRC)

ACTIVE COMPARATOR

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)

Socket 3 (Sub-Ischial Interface)

ACTIVE COMPARATOR

This arm included unilateral transfemoral amputees who were assessed while using the Sub-Ischial Interface socket.

Device: Sub-Ischial Interface (Sub-I)

Interventions

Ischial Ramus Containment (IRC)DEVICE

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

Socket 1 (Ischial Ramus Containment)
Dynamic Socket Ischial Ramus Containment (IRC)DEVICE

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

Socket 2 (Dynamic Socket IRC)
Sub-Ischial Interface (Sub-I)DEVICE

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

Socket 3 (Sub-Ischial Interface)

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral above the knee amputees of non-dysvascular etiology
  • lbs
  • ≥ 1 yr. of prosthetic experience
  • Independent community ambulator
  • Self-reported ability to walk for 20min consecutively

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • 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.

    PMID: 33856157DERIVED

Study Officials

  • Jason Highsmith, PhD, CP, PT

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2015

First Posted

May 16, 2016

Study Start

June 1, 2016

Primary Completion

March 30, 2018

Study Completion

March 30, 2018

Last Updated

April 3, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)