Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
1 participants
OBSERVATIONAL
2023-04-20
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
OTHER
Study Groups
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RibFix Advantage
Underwent surgical stabilization of rib fractures
RibFix Advantage
Intrathoracic rib fracture stabilization
Interventions
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RibFix Advantage
Intrathoracic rib fracture stabilization
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher W Towe, MD
Role: PRINCIPAL_INVESTIGATOR
UH Seidman Cancer Center
Locations
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UCI Health Surgery Services
Orange, California, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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References
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Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.
Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.
Nirula R, Allen B, Layman R, Falimirski ME, Somberg LB. Rib fracture stabilization in patients sustaining blunt chest injury. Am Surg. 2006 Apr;72(4):307-9. doi: 10.1177/000313480607200405.
Campbell N, Conaglen P, Martin K, Antippa P. Surgical stabilization of rib fractures using Inion OTPS wraps--techniques and quality of life follow-up. J Trauma. 2009 Sep;67(3):596-601. doi: 10.1097/TA.0b013e3181ad8cb7.
Related Links
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Rib Trauma Solutions
Other Identifiers
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0719-02
Identifier Type: -
Identifier Source: org_study_id
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