Evaluation of a Novel Transfemoral Prosthetic Socket System

Lower Limb Amputation Clinical Trial

Official title:

Prosthetic Socket System: Pilot Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01846845
• Other study ID #: VA-2012-Aim3
• Secondary ID: VA118-12-C-0038
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2013
• Last updated: June 27, 2013
• Start date: March 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: Ohio Willow Wood
• Contact: Ryan Schroeder
• Phone: 740-869-3377
• Email: ryans[@]owwco.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a novel prosthetic transfemoral socket system. A conventional prosthesis will be compared to the novel transfemoral socket system.

Description:

Conventional transfemoral socket designs impose an array of limitations on transfemoral amputee patients. Flexion, extension, and abduction are considerably impaired and end basic functions like sitting are usually uncomfortable or even painful. An alternative socket design that lowers the socket trim-lines and still provides structural support would greatly improve the socket comfort for transfemoral amputees.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consenting Adult

• Unilateral transfemoral amputee

• Currently suing a liner with prosthesis

• Uses a prosthesis to ambulate

• Ability to read, write, and understand English

• Available during regular business hours for appointments

Exclusion Criteria:

• Impaired contra lateral leg

• Ambulates with the aid of an additional assistive device (e.g. walker, cane, etc.)

• Diagnosis of renal failure

• Smoker

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lower Limb Amputation

Intervention

Device:
• Conventional Prosthetic Transfemoral Socket System
Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
• Novel Prosthetic transfemoral socket system
Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

Locations

Country	Name	City	State
United States	The Ohio State University Davis Heart and Lung Research Institute	Columbus	Ohio
United States	The Ohio Willow Wood Company	Mt. Sterling	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio Willow Wood	Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Skin temperature values	Change from baseline in skin temperature values at 1 month	1 month	No
Other	Prosthesis evaluation questionnaire (PEQ)	Change from baseline in prosthesis evaluation response at 1 month	1 month	No
Primary	Laser Doppler flowmetry tissue perfusion values	Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month	1 month	No
Secondary	Laser speckle flowmetry tissue perfusion values	Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month	1 month	No
Secondary	Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)	Change from baseline in hyperspectral imaging StO2% at 1 month	1 month	No
Secondary	Trans-Epidermal Water Loss values	Change from baseline in trans-epidermal water loss values at 1 month	1 month	No
Secondary	Surface electrical capacitance values	Change from baseline in surface electrical capacitance values at 1 month	1 month	No
Secondary	Elasticity (cutometry) values	Change from baseline in elasticity values at 1 month	1 month	No
Secondary	Torsional Ballistometry values	Change from baseline in torsional ballistometry values at 1 month	1 month	No