Clinical Evaluation of Direct Manufactured Prosthetic Sockets - Full Text View

Purpose

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.

Condition	Intervention	Phase
Amputation	Device: Traditional fabricated prosthetic socket Device: Direct manufactured (DM) prosthetic socket	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Clinical Evaluation of Direct Manufactured Prosthetic Sockets

Further study details as provided by Ohio Willow Wood:

Primary Outcome Measures:

Hanspal Socket Comfort Score (SCS) After Initial Socket Fitting [ Time Frame: Within the first 4-6 hrs ] [ Designated as safety issue: No ]
The Hanspal SCS assesses participant socket comfort on a continuous scale from 0 (most uncomfortable) to 10 (most comfortable)

Secondary Outcome Measures:

Participant Socket Preference After Initial Fitting [ Time Frame: Within the first 4-6 hours ] [ Designated as safety issue: No ]
Number of participants indicating socket preference after initial fitting of both socket interventions
Participant Socket Preference After 3 Months Usage of the Direct Manufactured Socket [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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

Enrollment:	10
Study Start Date:	September 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Traditional Socket First, then DM Socket 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 A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison. Other Name: Rectified prosthetic socket Device: 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)
DM Socket First, then Traditional Socket 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 A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison. Other Name: Rectified prosthetic socket Device: 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)

Arms

Assigned Interventions

Traditional Socket First, then DM Socket

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

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Other Name: Rectified prosthetic socket

Device: 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)

DM Socket First, then Traditional Socket

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

A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.

Other Name: Rectified prosthetic socket

Device: 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)

Detailed 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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155024

Locations

United States, Ohio
Ohio Willow Wood
Mt. Sterling, Ohio, United States, 43143

Sponsors and Collaborators

Ohio Willow Wood

Department of Defense

Investigators

Principal Investigator:

James Colvin, M.S.

Ohio Willow Wood

More Information

No publications provided

Responsible Party:	Ohio Willow Wood
ClinicalTrials.gov Identifier:	NCT01155024 History of Changes
Other Study ID Numbers:	W81XWH-08-10700-V1
Study First Received:	June 29, 2010
Results First Received:	October 26, 2011
Last Updated:	December 6, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Ohio Willow Wood:

Lower extremity amputation
Prosthetic Sockets
Direct Manufactured (DM)

ClinicalTrials.gov processed this record on May 16, 2013