Clinical Evaluation of Direct Manufactured Prosthetic Sockets

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.

Study Overview

• Status: Completed
• Conditions: Amputation
• Intervention / Treatment: Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket

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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Mt. Sterling, Ohio, United States, 43143
      • Ohio Willow Wood

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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	Device: Traditional fabricated prosthetic socket; A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.; Other Names: Rectified prosthetic socket; 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)
OTHER: 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	Device: Traditional fabricated prosthetic socket; A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.; Other Names: Rectified prosthetic socket; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting	The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)	Within the first 4-6 hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Socket Preference After Initial Fitting	Number of participants indicating socket preference after initial fitting of both socket interventions	Within the first 4-6 hours
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket	Number of participants indicating socket preference after 3 months usage of the direct manufactured prosthetic socket. Comparisons made to their previous traditional definitive prosthetic socket	3 months

Collaborators and Investigators

• Sponsor: Ohio Willow Wood
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: James Colvin, M.S., Ohio Willow Wood

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): September 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: June 29, 2010
• First Submitted That Met QC Criteria: June 29, 2010
• First Posted (ESTIMATE): July 1, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Lower extremity amputation; Prosthetic Sockets; Direct Manufactured (DM)
• Other Study ID Numbers: W81XWH-08-10700-V1