Rib; FractureNCT05146986
RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
An observational study of Rib; Fracture, run by Zimmer Biomet at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rib; Fracture
- What is being tested?
- Non surgical and Surgical
- Type of treatment
- Medical device
- How many people
- 167 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Jan 2022to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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)
Who cannot join
- 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:
Show all 12Show fewer
- 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.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Australia3 sites, 3 recruiting
- Recruiting
Flinders Medical Centre
Bedford Park, South Australia, 5042
Gregory David Rice, MD
Gregory David Rice
- Recruiting
The Alfred (Alfred Health)
Melbourne, Victoria, 31004
Silvana Marasco, Professor, S.Marasco@alfred.org.au
- Not yet recruiting
Hunter New England Health District
Sydney, New South Wales, 2301
Zsolt Janos Balogh
Zsolt Janos Balogh
South Korea2 sites, 2 recruiting
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Jong Hwan Moon
Jong Hwan Moon
- Recruiting
Yonsei Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Chun
Sung Byun Chun
About this study
Official title: Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
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.
Read the detailed 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.
- Conditions
- Rib; Fracture
- Being tested
- Non surgical and Surgical
- Keywords
- Non-flail chest
- Medical subject headings
- Rib Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non surgical and SurgicalDevice
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 group | Role | What they receive |
|---|---|---|
| Non-surgical group | Patients will receive analgesia and symptomatic management treatment Receives: Device: Non surgical and Surgical | |
| Surgical group | Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System Receives: Device: Non surgical and Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 2 weeks
Secondary outcomes (6)
Rate of Analgesic use
Analgesic use by the difference groups
Measured: 12 weeks
Length of Hospital stay
Length of Hospital stay by the difference groups
Measured: 12 weeks
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
Measured: 2 weeks, 6 weeks and 12 weeks
Pulmonary function
Pulmonary function will be assessed by the measuring the forced vital capacity (FVC) using a spirometer.
Measured: 12 weeks
Pulmonary function
Pulmonary function will be assessed by the measuring the forced expiratory volume (FEV) using a spirometer.
Measured: 2 weeks, 6 weeks and 12 weeks
Number of Participants with respiratory complications
Complications from the different groups assessed to be related to respiratory.
Measured: 2 weeks, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start2 Jan 2022
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rib; FractureStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvana Marasco, Professor, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146986
- Sponsor's protocol ID
- CSA2021-16SU
- Status last verified
- Mar 2024
- First submitted
- 15 Oct 2021
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
- ClinicalTrials.gov ID
- NCT05146986
- Acronym / sponsor ID
- CSA2021-16SU
- Conditions
- Rib; Fracture
- Keywords
- Non-flail chest
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-surgical group | – | Device: Non surgical and SurgicalPatients will receive analgesia and symptomatic management treatment |
| Surgical group | – | Device: Non surgical and SurgicalPatients will receive surgical treatment using RibFix Blu Thoracic Fixation System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non surgical and SurgicalFor 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. | Device | Non-surgical group, Surgical group |
Primary outcome
Thoracic pain as assessed by numeric Rating Scale (NRS)
Time frame: 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,
6 secondary outcomes
Rate of Analgesic use
Time frame: 12 weeks
Length of Hospital stay
Time frame: 12 weeks
Quality of life using EuroQoL-5L
Time frame: 2 weeks, 6 weeks and 12 weeks
Pulmonary function
Time frame: 12 weeks
Pulmonary function
Time frame: 2 weeks, 6 weeks and 12 weeks
Number of Participants with respiratory complications
Time frame: 2 weeks, 6 weeks and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvana Marasco, Professor principal investigator
The Alfred
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rib; Fracture, run by Zimmer Biomet at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Chong (97566687, irene.chong@zimmerbiomet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic pain as assessed by numeric Rating Scale (NRS) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.