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Recruiting NCT05146986

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

Conditions: Rib; Fracture

Sponsor: Zimmer Biomet

trial.available_in: БГ
Overview
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.
Description
The objective of this study is to evaluate the benefits of surgical stabilization of rib fractures (SSRF) in patients with non-flail chest rib fractures using RibFix Blu Thoracic Fixation System when compared to non-surgical (analgesia and symptomatic management) treatment. The study will include up to 167 cases of non-flail chest rib fractures with 95 cases in non-surgical treatment group and 72 cases in the surgical group. Each center may enroll up to maximum 30 cases to permit the assessment of outcome across a variety investigators and clinical settings. Enrolment will be competitive among sites and closed as soon as a total of 167 cases are recruited.
Who can participate
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.
Locations 2
Australia (1)
Hunter New England Health District
Sydney , New South Wales
NOT_YET_RECRUITING
South Korea (1)
Yonsei Wonju Severance Christian Hospital
Wŏnju , Gangwon-do
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
02.01.2022
Completion date
30.12.2026
Registry ID
NCT05146986
Source
anzctr
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