NCT01108536

Brief Summary

This study centers around the imaging of internal structures of residual limb by means of modern radiographic imaging techniques (Dynamic Radiography-DRSA). The purpose of our research is to further study the behavior of bones and soft tissue of the socket-stump interface during dynamic tasks such as walking or brisk walking. In the long term this research could prove a basis for improvements in the general design of sockets for the new generation of prosthetic devices.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
2 countries

3 active sites

Status
unknown

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

March 22, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 1, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

March 22, 2010

Last Update Submit

July 30, 2012

Conditions

Amputation

Keywords

prostheticssocket comfortamputation stumpamputee rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in skin/socket displacement with different prosthetic sockets

    one (1) year -baseline end of first year i.e. end of 2010 - with measurements at sixth and twelveth month

Study Arms (1)

adaptive trans-tibial socket

EXPERIMENTAL

subjects are fitted with experimental sockets.

Device: adaptive prosthetic socket

Interventions

adaptive prosthetic socketDEVICE

trans tibial socket with actuator zones (inflatable fluid bladders)

Also known as: SMART socket
adaptive trans-tibial socket

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • trans-tibial amputation, proficiency in prosthesis use

You may not qualify if:

  • pregnancy, balance impairment, stump skin breakdown

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

George Papaioannou Ph.d

New York, New York, 11023, United States

Location

Safe Llc Move Center and Laboratories

Milwaukee, New York, Nicosia, Wisconsin, 53211, United States

Location

SAFE LLC

Nicosia, Cyprus, Cyprus

Location

Study Officials

  • George Papaioannou, Ph.D

    SAVE LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 22, 2010

First Posted

April 22, 2010

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

August 1, 2012

Record last verified: 2012-07

Locations

CY(1)US(2)