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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05146986
Registration number
NCT05146986
Ethics application status
Date submitted
15/10/2021
Date registered
7/12/2021
Date last updated
7/03/2024
Titles & IDs
Public title
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
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Scientific title
Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
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Secondary ID [1]
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CSA2021-16SU
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rib; Fracture
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Devices - Non surgical and Surgical
Non-surgical group - Patients will receive analgesia and symptomatic management treatment
Surgical group - Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System
Treatment: Devices: 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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Thoracic pain as assessed by numeric Rating Scale (NRS)
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Assessment method [1]
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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,
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Timepoint [1]
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2 weeks
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Secondary outcome [1]
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Rate of Analgesic use
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Assessment method [1]
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Analgesic use by the difference groups
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Timepoint [1]
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12 weeks
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Secondary outcome [2]
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Length of Hospital stay
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Assessment method [2]
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Length of Hospital stay by the difference groups
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Timepoint [2]
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12 weeks
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Secondary outcome [3]
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Quality of life using EuroQoL-5L
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Assessment method [3]
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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
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Timepoint [3]
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2 weeks, 6 weeks and 12 weeks
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Secondary outcome [4]
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Pulmonary function
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Assessment method [4]
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Pulmonary function will be assessed by the measuring the forced vital capacity (FVC) using a spirometer.
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Pulmonary function
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Assessment method [5]
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Pulmonary function will be assessed by the measuring the forced expiratory volume (FEV) using a spirometer.
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Timepoint [5]
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2 weeks, 6 weeks and 12 weeks
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Secondary outcome [6]
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Number of Participants with respiratory complications
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Assessment method [6]
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Complications from the different groups assessed to be related to respiratory.
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Timepoint [6]
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2 weeks, 6 weeks and 12 weeks
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/01/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2026
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Actual
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Sample size
Target
167
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Hunter New England Health District - Sydney
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Recruitment hospital [2]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [3]
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The Alfred (Alfred Health) - Melbourne
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Recruitment postcode(s) [1]
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2301 - Sydney
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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31004 - Melbourne
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Recruitment outside Australia
Country [1]
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Korea, Republic of
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State/province [1]
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Gangwon-do
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Country [2]
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Korea, Republic of
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State/province [2]
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Gyeonggi-do
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Zimmer Biomet
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05146986
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Silvana Marasco, Professor
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Irene Chong
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Address
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Country
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Phone
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97566687
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05146986
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