FastFrame Knee Spanning and Damage Control Kit PMCF
Study Details
Study Description
Brief Summary
The purpose of this observational, prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
| Condition or Disease | Intervention/Treatment | Phase |
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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, 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 Design
Outcome Measures
Primary Outcome Measures
- Frequency and incidence of device-related adverse events and device deficiencies [2-4 weeks postoperative]
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 Outcome Measures
- All other adverse events [2-4 weeks postoperative]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient must be 18 years of age or older
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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:
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Patient has an active or suspected infection
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Patient has conditions that limit their ability and/or willingness to follow instructions during the healing process
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Patient has inadequate skin, bone, or neurovascular status
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Patient is a prisoner
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Patient is pregnant and/or breastfeeding
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Patient is a known current alcohol and/or drug abuser in the opinion of the Investigator
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland | Baltimore | Maryland | United States | 21212 |
Sponsors and Collaborators
- Zimmer Biomet
Investigators
- Study Director: Kacy Arnold, RN BMA, Zimmer Biomet
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CMU2017-95T