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Clinical Evaluation of Direct Manufactured Prosthetic Sockets

2014-07-23 21:08:34 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Amputation

Intervention

Traditional fabricated prosthetic socket, Direct manufactured prosthetic socket

Location

Ohio Willow Wood
Mt. Sterling
Ohio
United States
43143

Status

Not yet recruiting

Source

Ohio Willow Wood

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:34-0400

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Medical and Biotech [MESH] Definitions

A condition sometimes occurring after tooth extraction, particularly after traumatic extraction, resulting in a dry appearance of the exposed bone in the socket, due to disintegration or loss of the blood clot. It is basically a focal osteomyelitis without suppuration and is accompanied by severe pain (alveolalgia) and foul odor. (Dorland, 28th ed)

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A hollow part of the alveolar process of the MAXILLA or MANDIBLE where each tooth fits and is attached via the periodontal ligament.

A ready-made or custom-made prosthesis of glass or plastic shaped and colored to resemble the anterior portion of a normal eye and used for cosmetic reasons. It is attached to the anterior portion of an orbital implant (ORBITAL IMPLANTS) which is placed in the socket of an enucleated or eviscerated eye. (From Dorland, 28th ed)

Prosthetic replacements for arms, legs, and parts thereof.

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