RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
NCT ID: NCT05146986
Last Updated: 2024-03-07
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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RECRUITING
167 participants
OBSERVATIONAL
2022-01-02
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Non-surgical group
Patients will receive analgesia and symptomatic management treatment
Non surgical and Surgical
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment).
For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.
Surgical group
Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System
Non surgical and Surgical
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment).
For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.
Interventions
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Non surgical and Surgical
For non-surgical group, patients will receive non-surgical treatment (analgesia and symptomatic management treatment).
For surgical group, patients will receive surgical treatment using RibFix Blu Thoracic Fixation System.
Eligibility Criteria
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Inclusion Criteria
* Simple rib fracture with ≥ 3 consecutive ribs, and the broken ends showed clear displacements
* Indicated for surgical repair of rib fractures using RibFix Blu Thoracic Fixation System or non-surgical treatment (analgesia and symptomatic management treatment)
* Willing and able to complete scheduled follow-up evaluations as described in the study protocol
* Has participated in the Informed Consent process and is willing and able to sign an Institutional Review Board or Ethics Committee (IRB/EC) approved Patient Information/ Informed consent Form (PICF)
Exclusion Criteria
* Previous rib fractures or pulmonary problems, requiring continuous oxygen use at home pre-trauma
* Presence of any serious medical issues that placed patient in generally poor conditions such that he or she could not tolerate the surgery
* Chest trauma associated with severe craniocerebral injury, abdominal organ injury, severe spinal injury, limb fracture, or pelvic fracture requiring long-term bed rest
* Has serious medical disease that is a contraindication for general anesthesia, such as cerebral infarction, myocardial infarction and hemorrhagic syndrome
* Any contraindications listed in the manufacturer's Instruction to use for RibFix Blu Thoracic Fixation System as per below:
* Spanning a midline sternotomy
* Active Infection
* Foreign body sensitivity
* Is known to be pregnant
* Is a prisoner, known alcohol or drug user or mentally incompetent or unable to understand what participation in this study entails.
* Participation in another surgical intervention that may influence any of the outcome parameters.
18 Years
ALL
Yes
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Silvana Marasco, Professor
Role: PRINCIPAL_INVESTIGATOR
The Alfred
Locations
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Hunter New England Health District
Sydney, New South Wales, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Alfred (Alfred Health)
Melbourne, Victoria, Australia
Yonsei Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Zsolt Janos Balogh
Role: primary
Gregory David Rice, MD
Role: primary
Chun
Role: primary
Jong Hwan Moon
Role: primary
Other Identifiers
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CSA2021-16SU
Identifier Type: -
Identifier Source: org_study_id
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