Clinical Evaluation of Direct Manufactured Prosthetic Sockets

NCT ID: NCT01155024

Last Updated: 2012-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-09-30

Brief Summary

The purpose of this study is to evaluate a new prosthetic socket construction technique in order to improve the quality of care to lower extremity amputees.

Detailed Description

Many members of the Armed Forces and civilians are in need of prosthetic devices due to amputations resulting from gunshots, bombings, vehicular accidents, and other traumas. As the number of amputees increase at a high rate, the limited number of certified prosthetists is finding it harder to satisfy the patient demand. Therefore, the overall goal is to provide the Orthopedic & Prosthetic (O&P) industry with a tool that accommodates the increasing prosthetist to patient ratio and still provide acceptable product quality.

The practice of creating prosthetic sockets by the plaster-casting of amputees' residual limbs has been around for decades but continues to be the most commonly used method for the shape capture, modification and fabrication of prosthetic sockets. Using this traditional plaster-casting approach has many limitations that can now be overcome through the use of technology.

With the advancing developments in Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technologies over the past ten years, it is now possible to completely replace the plaster-casting approach with handheld, portable scanners.

While this current CAD/CAM approach certainly creates substantial efficiencies in the clinical aspects of creating the prosthetic socket, the actual manufacturing of the prosthetic device continues to rely on the use of a positive model and a lengthy manual fabrication process.

The continuing development of direct manufacturing technologies may serve as the final piece in the effective utilization of CAD/CAM in the care of prosthetic and orthotic patients. Direct manufacturing provides a means to quantify alterations and accurately reproduce prosthetic sockets. Additionally, direct manufacturing has the potential to reduce time, cost, and waste, as a result improve the quality and care ability to patients.

This study will compare two fabrication techniques for diagnostic and definitive sockets: manually fabricated (positive model technique) and direct manufactured (experimental).

Conditions

Amputation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Traditional Socket First, then DM Socket

Initial fitting of a traditional diagnostic prosthetic socket in first intervention period and initial fitting of a direct manufactured prosthetic socket in the second intervention period

Group Type: OTHER

Traditional fabricated prosthetic socket

Intervention Type: DEVICE

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Direct manufactured (DM) prosthetic socket

Intervention Type: DEVICE

A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)

DM Socket First, then Traditional Socket

Initial fitting of a direct manufactured prosthetic socket in first intervention period and initial fitting of a traditional diagnostic prosthetic socket in the second intervention period

Group Type: OTHER

Traditional fabricated prosthetic socket

Intervention Type: DEVICE

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Direct manufactured (DM) prosthetic socket

Intervention Type: DEVICE

A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)

Interventions

Traditional fabricated prosthetic socket

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Intervention Type: DEVICE

Direct manufactured (DM) prosthetic socket

A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)

Intervention Type: DEVICE

Other Intervention Names

Rectified prosthetic socket

Eligibility Criteria

Inclusion Criteria

• Be a lower extremity amputee longer than one year
• Be a consenting adult (at least 18 years or age or older)
• Albe to ambulate in current prosthesis without an aid (can, crutches or walker) for 30 minutes without rest
• Currently using a liner with prosthesis
• Be available during regular business hours for appointments

Exclusion Criteria

• An inability to give informed consent
• Presence of any sores, lacerations or rashes on the residual limb
• Impaired contra lateral foot
• Poor distal sensation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Ohio Willow Wood

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Colvin, M.S.

Role: PRINCIPAL_INVESTIGATOR

Ohio Willow Wood

Locations

Ohio Willow Wood

Mount Sterling, Ohio, United States

Countries

United States

Other Identifiers

W81XWH-08-10700-V1

Identifier Type: -

Identifier Source: org_study_id