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RibFix Advantage™ Post-Market Follow-Up (ZB-PIONEER)

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: NCT05179005
Recruitment Status : Not yet recruiting
First Posted : January 5, 2022
Last Update Posted : January 5, 2022
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

Condition or disease Intervention/treatment
Rib Fractures Device: RibFix Advantage

Detailed Description:
Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Other
Official Title: Zimmer Biomet Patient Outcome and Experience After Chest Wall Repair With RibFix Advantage™
Estimated Study Start Date : April 1, 2022
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : March 31, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
RibFix Advantage
Underwent surgical stabilization of rib fractures
Device: RibFix Advantage
Intrathoracic rib fracture stabilization




Primary Outcome Measures :
  1. Rate of re-operation [ Time Frame: 3 months post-op ]
    Number of subjects who needed surgical re-intervention related to rib fracture repair


Secondary Outcome Measures :
  1. Length of stay in hospital [ Time Frame: Day 0 (surgery) to Day 7 ]
    Time spent in hospital following surgery


Other Outcome Measures:
  1. Overall quality of life [ Time Frame: Before surgery and 3 months post-op ]
    American Chronic Pain Association Quality of Life scale

  2. Respiratory-related quality of life [ Time Frame: 3 months post-op ]
    Chronic Pulmonary Disease Assessment Test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Thoracic trauma comprises 20-25% of all traumas worldwide and constitutes the third most common cause of death after abdominal injury and head trauma in polytrauma patients.

Thoracic trauma directly accounts for approximately 25% of trauma-related mortality and is a contributing factor in another 25% of such cases. The incidence of rib fractures due to trauma has been reported by various studies to range between 7 and 40%.

There is no standard treatment for rib fractures, though there are several options. Failure to treat rib fracture pain can lead to reduced movement, cough suppression, and secondary infection.

The conservative option for caring for a rib fracture involves the non-operative management of pain.

Criteria

Inclusion Criteria:

  • 18-80 years of age, male or female
  • Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
  • Minimum amount of follow-up data available, including one visit post-surgery
  • Willing and able to sign an Informed Consent for research
  • Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery

Exclusion Criteria:

  • Latent or active infection with positive culture at the time of implantation
  • Documented history of metal sensitivity
  • Documented psychiatric condition preventing the patient from following post-op care instructions
  • Fixation of the first and/or second (true) vertebrosternal rib
  • Bilateral rib fractures
  • Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization
  • Lung injury (open pneumothorax, tension pneumothorax, hemothorax > 1L, pulmonary contusion requiring mechanical ventilation)

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): NCT05179005


Contacts
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Contact: Eric W Bast, JD 9047418541 eric.bast@zimmerbiomet.com
Contact: Oscar A Gonzalez, MD, DNP 9047419277 oscar.gonzalezmonteagudo@zimmerbiomet.com

Locations
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United States, California
UCI Health Surgery Services
Orange, California, United States, 92868
Principal Investigator: Sebastian Schubl, MD         
United States, Ohio
UH Seidman Cancer Center
Cleveland, Ohio, United States, 44106
Principal Investigator: Christopher W Towe, MD         
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Principal Investigator: Christopher W Towe, MD UH Seidman Cancer Center
Publications:
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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT05179005    
Other Study ID Numbers: 0719-02
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: January 5, 2022
Last Verified: January 2022
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
Additional relevant MeSH terms:
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Rib Fractures
Fractures, Bone
Wounds and Injuries
Thoracic Injuries
Imidacloprid
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs