FastFrame Knee Spanning and Damage Control Kit PMCF

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

Detailed Description
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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.

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

Conditions
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Fracture, Fractures, Bone, Fractures, Closed, Fractures, Open

Intervention / Treatment
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* Device: FastFrame External Fixation System - Knee Spanning or Damage Control Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FastFrame External Fixation System - Knee Spanning or Damage Control Kit<br>The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System. | Device: FastFrame External Fixation System - Knee Spanning or Damage Control Kit<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency and incidence of 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.). | 2-4 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All other 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. | 2-4 weeks postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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External fixator, temporary stabilization