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Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device (RF-Advantage)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163224
Recruitment Status : Withdrawn (Sponsor strategy change)
First Posted : November 14, 2019
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
A retrospective review of demographics and adverse events from cases completed with the RibFix Advantage System. Evaluation of device integrity, and performance by a prospective CT scan with a minimum of 3 months post-implantation.

Condition or disease Intervention/treatment
Rib Fracture Multiple Device: RibFix Advantage

Detailed Description:

The RibFix Advantage System is a novel intrathoracic titanium plating system that is FDA-cleared for the treatment of rib fractures. The RibFix Advantage System is designed to be implanted in a less invasive procedure where plates are introduced and placed on the pleural cortex of the rib during video-assisted thoracoscopic surgery. Intrathoracic plate placement allows for smaller cutaneous incisions and less muscle disruption, which may aid in patient recovery compared to traditional open reduction internal fixation systems that are currently available.

The purpose of this study is to gather the first clinical data on this novel device in the context of a case series of patients with radiologic and quality-of-life follow-up.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Minimal Invasive Approach for Surgical Repair of Rib Fractures With a Novel Intrathoracic Device. Case Series
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: RibFix Advantage
    Class II device in the United States; consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys. When fully assembled, the bridge plate is placed on the underside of the rib (pleural cortex); the threaded locking posts extend through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior (cutaneous) side of the rib. The combined threaded locking post and cap provides for fixation of the bridge and stabilization of the fracture.


Primary Outcome Measures :
  1. Fracture stability [ Time Frame: 3 months post-implantation ]
    Evaluated by a computed tomography (CT) scan. Rib fractures repaired with RibFix Advantage should demonstrate continuity without overlap

  2. Device integrity [ Time Frame: 3 months post-implantation ]
    Evaluated by a computed tomography (CT) scan. Images should demonstrate no plate migration, no post/cap migration and no plate fracture


Secondary Outcome Measures :
  1. Adverse Events of Interest [ Time Frame: From the the date of implantation until the day of hospital discharge, or up to 10 days post-implantation, whichever occurs first; 30 days post surgery; 3 month post-implantation ]
    Includes: Chest infections, Empyema, Mediastinitis. Wound infection, Wound dehiscence, Chest wall deformity related to the device, Pleural effusion related to the device, Hemothorax related to the device, Pneumothorax related to the device and Hemo-pneumothorax related to the device



Information from the National Library of Medicine

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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 treated for rib fracture repair using RibFix Advantage System alone or in combination with other methods for rib fracture repair
Criteria

Inclusion Criteria:

  • Male or Female
  • ≥ 18 years old (no upper limit)
  • Underwent surgical repair of rib fracture(s) with the RibFix Advantage System alone or in combination with other systems for fracture repair
  • Signed Informed Consent Form for participation in a clinical trial
  • Willing and able to return for a follow-up visit (includes a computed tomography (CT) scan of the chest)

Exclusion Criteria:

  • Off label use of RibFix Advantage (e.g., active or latent infection at the time of implantation, sepsis, metal sensitivity)

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): NCT04163224


Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: Mark Sun Zimmer Biomet
Publications of Results:

Other Publications:
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT04163224    
Other Study ID Numbers: 0719-2
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
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.: No
Keywords provided by Zimmer Biomet:
multiple rib fractures
chest stabilization
rib plates
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Fractures, Multiple
Wounds and Injuries
Thoracic Injuries
Multiple Trauma
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs