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Clinical Evaluation of Direct Manufactured Prosthetic Sockets

NCT01155024 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-01-11

Study results available
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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.

Conditions

  • Amputation

Interventions

DEVICE

Traditional fabricated prosthetic socket

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

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)

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Ohio Willow Wood

    lead INDUSTRY

Principal Investigators

  • James Colvin, M.S. · Ohio Willow Wood

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01155024 on ClinicalTrials.gov