FastFrame Knee Spanning and Damage Control Kit PMCF
Fracture, Fractures, Bone, Fractures, Closed
About this trial
This is an interventional treatment trial for Fracture focused on measuring External fixator, temporary stabilization
Eligibility Criteria
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 or neurologic condition that will not allow for proper Informed Consent and/or participation in follow-up program in the opinion of the Investigator
Sites / Locations
- University of MarylandRecruiting
Arms of the Study
Arm 1
Experimental
FastFrame External Fixation System - Knee Spanning or Damage Control Kit
The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.