Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Conditions
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Amputation

Intervention / Treatment
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* Device: Traditional fabricated prosthetic socket
* Device: Direct manufactured (DM) prosthetic socket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional Socket First, then DM Socket<br>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<br>* A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.<br>* Other names: Rectified prosthetic socket;Device: Direct manufactured (DM) prosthetic socket<br>* 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)<br>|
| Other: DM Socket First, then Traditional Socket<br>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<br>* A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.<br>* Other names: Rectified prosthetic socket;Device: Direct manufactured (DM) prosthetic socket<br>* 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)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower extremity amputation, Prosthetic Sockets, Direct Manufactured (DM)