Early Feasibility Study of the Percutaneous Osseointegrated Prosthesis (POP)
NCT ID: NCT02720159
Last Updated: 2016-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TREATMENT
Percutaneous Osseintegrated Prosthesis
Interventions
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Percutaneous Osseintegrated Prosthesis
Eligibility Criteria
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Inclusion Criteria
* 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
* More than 1 limb amputated
* Has insulin dependent or adult onset diabetes
* Recent tobacco use
18 Years
ALL
No
Sponsors
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VA Salt Lake City Health Care System
FED
Encore Medical, L.P.
INDUSTRY
Responsible Party
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Locations
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George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, United States
Countries
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Facility Contacts
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References
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Sinclair S, Beck JP, Webster J, Agarwal J, Gillespie B, Stevens P, Gililland J, Kubiak E. The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study. Arch Phys Med Rehabil. 2022 Nov;103(11):2092-2104. doi: 10.1016/j.apmr.2022.06.008. Epub 2022 Jul 29.
Other Identifiers
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POP
Identifier Type: -
Identifier Source: org_study_id
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