Comparing surgical and non-surgical treatment for rib fractures
Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Zimmer Biomet · NCT05146986
This study is testing whether a new surgical method for fixing rib fractures works better than regular pain management for people with non-flail chest rib fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 167 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zimmer Biomet (industry) |
| Locations | 5 sites (Sydney, New South Wales and 4 other locations) |
| Trial ID | NCT05146986 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the effectiveness of the RibFix Blu Thoracic Fixation System for surgical stabilization of non-flail chest rib fractures compared to non-surgical treatment methods such as analgesia and symptomatic management. Conducted across multiple centers, the study will enroll up to 167 patients, with a competitive recruitment process among sites. The goal is to assess outcomes from both treatment approaches, providing insights into the benefits of surgical intervention for this specific type of rib fracture.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with simple rib fractures involving three or more consecutive ribs that are displaced.
Not a fit: Patients with flail chest rib fractures or those with serious medical conditions that prevent them from tolerating surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting surgical treatment as a more effective option for patients with non-flail chest rib fractures.
How similar studies have performed: While there is existing literature on surgical stabilization of rib fractures, this specific approach using the RibFix Blu system is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Sydney, New South Wales and 4 other locations
- Hunter New England Health District — Sydney, New South Wales, Australia (NOT_YET_RECRUITING)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (RECRUITING)
- The Alfred (Alfred Health) — Melbourne, Victoria, Australia (RECRUITING)
- Yonsei Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (RECRUITING)
- Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (RECRUITING)
Study contacts
- Principal investigator: Silvana Marasco, Professor — The Alfred
- Study coordinator: Irene Chong
- Email: irene.chong@zimmerbiomet.com
- Phone: 97566687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rib, Fracture, Non-flail chest