FastFrame Knee Spanning and Damage Control Kit PMCF

Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730739
• Other study ID #: CMU2017-95T
• Status: Recruiting
• Phase: N/A
• Start date: June 18, 2021
• Est. completion date: March 30, 2024

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: Octavia Gladden
• Phone: 7044930178
• Email: octavia.gladden[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fracture
• Fractures, Bone
• Fractures, Closed
• Fractures, Open

Intervention

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.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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