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Clinical Trial Summary

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.


Clinical Trial Description

This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05206981
Study type Observational [Patient Registry]
Source IlluminOss Medical, Inc.
Contact Lisa Holt, PhD
Phone 401-714-0008
Email [email protected]
Status Recruiting
Phase
Start date June 11, 2021
Completion date December 2024

See also
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Terminated NCT01464645 - Post-Market Study of the Modular Revision Hip System