Evaluation of a Novel Transfemoral Prosthetic Socket System

• Sponsor: Ohio Willow Wood (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01846845
• Collaborator: Ohio State University (Other)
• Enrollment: 8
• Locations: 2
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Amputation	Device: Conventional Prosthetic Transfemoral Socket System; Device: Novel Prosthetic transfemoral socket system	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Prosthetic Socket System: Pilot Assessment
• Study Start Date: Mar 1, 2013
• Anticipated Primary Completion Date: Sep 1, 2014
• Anticipated Study Completion Date: Sep 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Laser Doppler flowmetry tissue perfusion values [1 month]

   Change from baseline in Laser Doppler flowmetry tissue perfusion values at 1 month

Secondary Outcome Measures

1. Laser speckle flowmetry tissue perfusion values [1 month]

   Change from baseline in laser speckle flowmetry tissue perfusion values at 1 month

2. Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) [1 month]

   Change from baseline in hyperspectral imaging StO2% at 1 month

3. Trans-Epidermal Water Loss values [1 month]

   Change from baseline in trans-epidermal water loss values at 1 month

4. Surface electrical capacitance values [1 month]

   Change from baseline in surface electrical capacitance values at 1 month

5. Elasticity (cutometry) values [1 month]

   Change from baseline in elasticity values at 1 month

6. Torsional Ballistometry values [1 month]

   Change from baseline in torsional ballistometry values at 1 month

Other Outcome Measures

1. Skin temperature values [1 month]

   Change from baseline in skin temperature values at 1 month

2. Prosthesis evaluation questionnaire (PEQ) [1 month]

   Change from baseline in prosthesis evaluation response at 1 month

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Davis Heart and Lung Research Institute	Columbus	Ohio	United States	43210
2	The Ohio Willow Wood Company	Mt. Sterling	Ohio	United States	43143

Sponsors and Collaborators

• Ohio Willow Wood
• Ohio State University

Investigators

• Principal Investigator: Gayle Gordillo, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ohio Willow Wood
• ClinicalTrials.gov Identifier: NCT01846845
• Other Study ID Numbers: VA-2012-Aim3; VA118-12-C-0038
• First Posted: May 3, 2013
• Last Update Posted: Jul 1, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Ohio Willow Wood: Amputee

Study Results

No Results Posted as of Jul 1, 2013