Status:
TERMINATED
FastFrame Knee Spanning and Damage Control Kit PMCF
Lead Sponsor:
Zimmer Biomet
Conditions:
Fracture
Fractures, Bone
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
Detailed 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, prospect...
Eligibility Criteria
Inclusion
- Patient must be 18 years of age or older
- Patient must be treated with either the Knee Spanning or Damage Control FastFrame External Fixation System according to the European Economic Area (EEA) indications\*
- EEA Indications (a subset of the cleared US indications):
- The FastFrame External Fixation System - Knee Spanning Kit is indicated for use in treatment of long bone (distal femur, proximal tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures about the knee, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
- The FastFrame External Fixation System - Damage Control Kit is indicated for use in treatment of mid-shaft long bone (femur, tibia) fractures. Specifically, the system is intended for temporary stabilization of open or closed fractures of the femur and tibia, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated.
Exclusion
- Patient has an active or suspected infection
- Patient has conditions that limit their ability and/or willingness to follow instructions during the healing process
- Patient has inadequate skin, bone, or neurovascular status
- Patient is a prisoner
- Patient is pregnant and/or breastfeeding
- Patient is a known current alcohol and/or drug abuser in the opinion of the Investigator
- Patient has a mental or neurologic condition that will not allow for proper Informed Consent and/or participation in follow-up program in the opinion of the Investigator
Key Trial Info
Start Date :
June 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04730739
Start Date
June 18 2021
End Date
July 22 2024
Last Update
February 10 2025
Active Locations (1)
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1
University of Maryland
Baltimore, Maryland, United States, 21212