Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Prospective, Early Feasibility Study to Characterize the Efficacy and Safety of a Percutaneous Osseointegrated Prosthesis

The purpose of the clinical study is to characterize the efficacy and safety of a
Percutaneous Osseointegrated Prosthesis (POP) device that can provide a satisfactory
platform for direct skeletal attachment of prosthetic limbs, which includes a subdermal
seal, thus allowing a proper biobarrier around the implant.


Inclusion Criteria:

- US Military veteran with transfemoral amputation that is not a result of dysvascular
disease

- Has used or is using a "socket suspension technology" prosthesis

- Use of non-propulsive, passive microprocessor-regulated devices

- Agrees not to participate in high levels of physical activity while in the study

- Subject meets anatomical and eligibility criteria for the investigational device

Exclusion Criteria:

- Currently on active military duty

- More than 1 limb amputated

- Has insulin dependent or adult onset diabetes

- Recent tobacco use
We found this trial at
1
site
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah 84148
Principal Investigator: Erik Kubiak, MD
Phone: 801-582-1565
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mi
from
Salt Lake City, UT
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