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FastFrame Knee Spanning and Damage Control Kit PMCF

Fracture Clinical Trial

Official title:
FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit

Clinical Trial Summary

The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.

Clinical Trial Description

Study Title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study (Knee Spanning Kit and Damage Control Kit) Sponsor: Zimmer Biomet Study Design: Prospective enrollment, prospective follow-up, single cohort study Clinical Phase: Postmarket Number of Sites: Up to three sites Study Duration per Subject: Subjects will be enrolled in the study until the time of exchange of their FastFrame Kit to another device. Typically, this exchange occurs 2-4 weeks after injury. Primary Objective: The objective of this observational, prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation. Primary Endpoint: Frequency and incidence of device-related adverse events and device deficiencies before the FastFrame External Fixation System is exchanged by another device (i.e. plates, screws, etc.). Secondary Endpoint: Adverse events that occur between application of the FastFrame External Fixation System and exchange with another device that do not fall within the primary endpoint. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04730739
Study type Interventional
Source Zimmer Biomet
Contact Octavia Gladden
Phone 7044930178
Email octavia.gladden@zimmerbiomet.com
Status Recruiting
Phase N/A
Start date June 18, 2021
Completion date March 30, 2024
View Details
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