Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Amputation Clinical Trial

Official title:

Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155024
• Other study ID #: W81XWH-08-10700-V1
• Status: Completed
• Phase: Phase 2
• First received: June 29, 2010
• Last updated: December 6, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: December 2011
• Source: Ohio Willow Wood
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Amputation

Intervention

Device:
• Traditional fabricated prosthetic socket
A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.
• 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)

Locations

Country	Name	City	State
United States	Ohio Willow Wood	Mt. Sterling	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio Willow Wood	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No