Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Phase 2

Completed

Conditions: Amputation

Interventions: Device: Traditional fabricated prosthetic socket
Device: Direct manufactured (DM) prosthetic socket

Registration Number: NCT01155024

Lead Sponsor: Ohio Willow Wood

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Traditional Socket First, then DM Socket	Traditional fabricated prosthetic 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
Traditional Socket First, then DM Socket	Direct manufactured (DM) prosthetic 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
DM Socket First, then Traditional Socket	Direct manufactured (DM) prosthetic 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
DM Socket First, then Traditional Socket	Traditional fabricated prosthetic 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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participant Socket Preference After Initial Fitting	Within the first 4-6 hours	Number of participants indicating socket preference after initial fitting of both socket interventions
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket	3 months	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