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FastFrame Knee Spanning and Damage Control Kit PMCF

Primary Purpose

Fracture, Fractures, Bone, Fractures, Closed

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

About this trial

This is an interventional treatment trial for Fracture focused on measuring External fixator, temporary stabilization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of MarylandRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Arm Description

The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.

Outcomes

Primary Outcome Measures

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.).

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04730739

First Posted

January 25, 2021

Last Updated

April 18, 2023

Sponsor

Zimmer Biomet

1. Study Identification

Unique Protocol Identification Number

NCT04730739

Brief Title

FastFrame Knee Spanning and Damage Control Kit PMCF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 18, 2021 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zimmer Biomet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

External fixator, temporary stabilization

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Arm Type

Experimental

Arm Description

The patient must have been treated with either Knee Spanning or Damage Control FastFrame External Fixation System.

Intervention Type

Device

Intervention Name(s)

FastFrame External Fixation System - Knee Spanning or Damage Control Kit

Intervention Description

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.

Primary Outcome Measure Information:

Title

Frequency and incidence of device-related adverse events and device deficiencies

Description

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.).

Time Frame

2-4 weeks postoperative

Secondary Outcome Measure Information:

Title

All other adverse events

Description

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.

Time Frame

2-4 weeks postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ryan Boylan, MBA

Phone

574-527-7934

Ryan.Boylan@zimmerbiomet.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erin Osborn

Organizational Affiliation

Zimmer Biomet

Official's Role

Study Director

Facility Information:

Facility Name

University of Maryland

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21212

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haley Demyanovich

Phone

410-706-3935

HDemyanovich@som.umaryland.edu

First Name & Middle Initial & Last Name & Degree

Marcus Sciadini, MD

12. IPD Sharing Statement

Plan to Share IPD

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FastFrame Knee Spanning and Damage Control Kit PMCF

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