Evaluation of a Novel Transfemoral Prosthetic Socket System

Prosthetic Socket System: Pilot Assessment

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.

Study Overview

• Status: Unknown
• Conditions: Lower Limb Amputation
• Intervention / Treatment: Device: Conventional Prosthetic Transfemoral Socket System; Device: Novel Prosthetic transfemoral socket system

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Davis Heart and Lung Research Institute
    • Mt. Sterling, Ohio, United States, 43143
      • Recruiting
      • The Ohio Willow Wood Company
      • Contact: Jim Colvin; Phone Number: 740-869-3377; Email: jimc@owwco.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional TF Socket System; Conventional Prosthetic Transfemoral Socket System	Device: Conventional Prosthetic Transfemoral Socket System; Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket; Other Names: Ischial Containment; Pin Transfemoral Socket; Suction Transfemoroal Socket; Above the knee (AK) socket
EXPERIMENTAL: Novel TF Socket System; Novel Prosthetic Transfemoral Socket System	Device: Novel Prosthetic transfemoral socket system; Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser Doppler flowmetry tissue perfusion values	Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser speckle flowmetry tissue perfusion values	Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month	1 month
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%)	Change from baseline in hyperspectral imaging StO2% at 1 month	1 month
Trans-Epidermal Water Loss values	Change from baseline in trans-epidermal water loss values at 1 month	1 month
Surface electrical capacitance values	Change from baseline in surface electrical capacitance values at 1 month	1 month
Elasticity (cutometry) values	Change from baseline in elasticity values at 1 month	1 month
Torsional Ballistometry values	Change from baseline in torsional ballistometry values at 1 month	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin temperature values	Change from baseline in skin temperature values at 1 month	1 month
Prosthesis evaluation questionnaire (PEQ)	Change from baseline in prosthesis evaluation response at 1 month	1 month

Collaborators and Investigators

• Sponsor: Ohio Willow Wood
• Collaborators: Ohio State University

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2014
• Study Completion (ANTICIPATED): September 1, 2014

Study Registration Dates

• First Submitted: May 1, 2013
• First Submitted That Met QC Criteria: May 1, 2013
• First Posted (ESTIMATE): May 3, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 27, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Amputee
• Other Study ID Numbers: VA-2012-Aim3; VA118-12-C-0038 (Other Grant/Funding Number: Veterans Affairs Innovation Initiative)