Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
NCT02720159 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-03-25
Summary
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.
Conditions
- Traumatic Amputee
Interventions
- DEVICE
-
Percutaneous Osseintegrated Prosthesis
Sponsors & Collaborators
-
VA Salt Lake City Health Care System
collaborator FED -
Encore Medical, L.P.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2017-12-31
Countries
- United States
Study Locations
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