The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
The FastFrame External Fixation Systems - Knee Spanning Kit and Damage Control Kit are single-use external fixators that are sterile packed with all required components for convenience of the end user.
University of Maryland
Baltimore, Maryland, United States
Number of Participants With Device-related Adverse Events and Device Deficiencies
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.).
Time frame: 2-4 weeks postoperative
Number of Participants With Another Device-related Adverse Events
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.
Time frame: 2-4 weeks postoperative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.