RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
ConditionRib; Fracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Non surgical and Surgical
Treatment groups
167 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov