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FastFrame Knee Spanning and Damage Control Kit PMCF

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730739
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

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

Condition or disease Intervention/treatment
Fracture Fractures, Bone Fractures, Closed Fractures, Open Device: FastFrame External Fixation System - Knee Spanning Kit or FastFrame External Fixation System - Damage Control Kit

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FastFrame™ External Fixation System Post-Market Clinical Follow-Up Study: Knee Spanning Kit and Damage Control Kit
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : March 1, 2024
Groups and Cohorts
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Intervention Details:
  • Device: FastFrame External Fixation System - Knee Spanning Kit or FastFrame External Fixation System - 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.

Outcome Measures
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Primary Outcome Measures :
  1. Frequency and incidence of device-related adverse events and device deficiencies [ Time Frame: 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 :
  1. All other adverse events [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have undergone fracture stabilization using the FastFrame External Fixation System - Knee Spanning Kit or Damage Control Kit
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730739


Contacts
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Contact: Madison Murphy 574-526-2059 madison.murphy@zimmerbiomet.com
Contact: Ryan Boylan, MBA 574-527-7934 Ryan.Boylan@zimmerbiomet.com

Locations
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United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21212
Contact: Haley Demyanovich    410-706-3935    HDemyanovich@som.umaryland.edu   
Principal Investigator: Marcus Sciadini, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Kacy Arnold, RN BMA Zimmer Biomet
More Information
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04730739    
Other Study ID Numbers: CMU2017-95T
First Posted: January 29, 2021    Key Record Dates
Last Update Posted: December 16, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Zimmer Biomet:
External fixator, temporary stabilization
Additional relevant MeSH terms:
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Fractures, Bone
Fractures, Closed
Fractures, Open
Wounds and Injuries