FastFrame Knee Spanning and Damage Control Kit PMCF (NCT04730739) | Clinical Trial Compass
TerminatedNot Applicable
FastFrame Knee Spanning and Damage Control Kit PMCF
Stopped: Product will not be taken to EU, thus no PMCF requirements.
United States33 participantsStarted 2021-06-18
Plain-language summary
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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…
What they're measuring
1
Number of Participants With Device-related Adverse Events and Device Deficiencies