FastFrame Knee Spanning and Damage Control Kit PMCF

NCT ID: NCT04730739

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-18
• Study Completion Date: 2024-07-22

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.

Conditions

Fracture; Fractures, Bone; Fractures, Closed; Fractures, Open

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Osborn

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CMU2017-95T

Identifier Type: -

Identifier Source: org_study_id