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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01155024
Other study ID # W81XWH-08-10700-V1
Secondary ID
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


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
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