FastFrame Knee Spanning and Damage Control Kit PMCF

Not Applicable

Terminated

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

Interventions: Device: FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Registration Number: NCT04730739

Lead Sponsor: Zimmer Biomet

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

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 33

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FastFrame External Fixation System - Knee Spanning or Damage Control Kit	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With 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

Name	Time	Method
Number of Participants With Another Device-related 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.