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
This trial accepts healthy volunteersQualifiers
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 population
Patients diagnosed with non-flail chest rib fractures who plan to receive surgical treatment with RibFix Blu Thoracic Fixation System or non-surgical treatment, and meet the inclusion criteria and do not meet any exclusion criteria will be eligible to participate in the study
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Non surgical and Surgical
DeviceFor 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.
Treatment groups
167 Participants
are divided into 2 treatment groupsGroup A: Non-surgical group1 intervention
Group B: Surgical group1 intervention
Trial outcomes
Primary outcomes
1
Thoracic pain as assessed by numeric Rating Scale (NRS)
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,
Time frame
2 weeksSecondary outcomes
1
Rate of Analgesic use
Analgesic use by the difference groups
Time frame
12 weeks2
Length of Hospital stay
Length of Hospital stay by the difference groups
Time frame
12 weeks3
Quality of life using EuroQoL-5L
Health related qualify of life using EuroQoL-5L(EQ-5D-5L) questionnaires from the different groups. A standardized measure of health-related quality of life states consisting of 5 dimensions, namely mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L version was used in the study. Each dimension has 5 responses recording 5 levels of severity (no problems/slight problems/moderate problems/severe problems or extreme problems). The responses to the EQ-5D dimensions are used to obtain a single EQ-5D index value where 1 represents full health and 0 represents death. The questionnaire also includes a vertical, visual analogue scale (EQ VAS) for the respondents to record their self-rated health where the 2 extreme ends of the scale are labelled as 'Best imaginable health state' and 'Worst imaginable health state' respectively
Time frame
2 weeks, 6 weeks and 12 weeks4
Pulmonary function
Pulmonary function will be assessed by the measuring the forced vital capacity (FVC) using a spirometer.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov