Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Ohio Willow Wood

Status and phase: Completed; Phase 2

Conditions: Amputation

Treatments: Device: Traditional fabricated prosthetic socket; Device: Direct manufactured (DM) prosthetic socket

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01155024

W81XWH-08-10700-V1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

10 participants in 2 patient groups

Traditional Socket First, then DM Socket

Other group

Description:

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

Treatment:

Device: Traditional fabricated prosthetic socket

Device: Direct manufactured (DM) prosthetic socket

DM Socket First, then Traditional Socket

Other group

Description:

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

Treatment:

Device: Traditional fabricated prosthetic socket

Device: Direct manufactured (DM) prosthetic socket