Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)

Status unconfirmed · Not applicable

Conditions studied: Traumatic Amputee

In brief

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.

Key facts

Study ID

NCT02720159

Run by

Encore Medical, L.P.

People needed

10

Starts

2015-12-01

Last updated by the study team

2016-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Currently on active military duty
• More than 1 limb amputated
• Has insulin dependent or adult onset diabetes
• Recent tobacco use

Where it is running

• George E. Wahlen Department of Veterans Affairs Medical Center — Salt Lake City, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

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