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Recruiting Observational

RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

NCT05146986 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-01-02
Last updated
2024-03-07

Condition(s) studied

Rib; Fracture

Investigational drug(s) / intervention(s)

Non surgical and Surgical

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.

Study summary

This is a prospective, multi-center, observational, cohort study involving skilled cardiothoracic surgeons who are experienced in implanting the treatment of non-flail chest rib fractures and the use of RibFix Blu Thoracic Fixation System.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Age 18 and above (inclusive) * 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: * Flail chest rib fractures based on radiological or clinical findings * 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.

Primary outcome measure(s)

  • Thoracic pain as assessed by numeric Rating Scale (NRS) — 2 weeks
    Level of thoracic pain determined using a numeric Rating Scale (NRS). Thoracic pain will be determined using an 11-point Numeric Rating Scale (NRS) in which 0 implicates no pain and 10 the worst pain. If a subject is not able to provide a response to the level of thoracic pain,

Trial sites (5)

FacilityCityRegionStatus
Hunter New England Health District Sydney New South Wales Not Yet Recruiting
Flinders Medical Centre Bedford Park South Australia Recruiting
The Alfred (Alfred Health) Melbourne Victoria Recruiting
Yonsei Wonju Severance Christian Hospital Wŏnju Gangwon-do Recruiting
Ajou University Hospital Suwon Gyeonggi-do Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05146986 on ClinicalTrials.gov ↗ ← All trials in South Korea