FastFrame Knee Spanning and Damage Control Kit PMCF
NCT04730739 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33
Last updated 2025-02-10
Summary
The purpose of this prospective study is to confirm safety and performance of the FastFrame External Fixation System and corresponding instrumentation.
Conditions
- Fracture
- Fractures, Bone
- Fractures, Closed
- Fractures, Open
Interventions
- DEVICE
-
FastFrame External Fixation System - Knee Spanning or Damage Control Kit
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.
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Erin Osborn · Zimmer Biomet
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-18
- Primary Completion
- 2024-06-30
- Completion
- 2024-07-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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