Clinical trial NCT05146986: RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Official title: Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rib; Fracture
Keywords: Non-flail chest
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

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.

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.

Eligibility 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.

Primary outcomes:
measure: Thoracic pain as assessed by numeric Rating Scale (NRS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Rate of Analgesic use
timeFrame: 12 weeks
measure: Length of Hospital stay
timeFrame: 12 weeks
measure: Quality of life using EuroQoL-5L
timeFrame: 2 weeks, 6 weeks and 12 weeks
measure: Pulmonary function
timeFrame: 12 weeks
measure: Pulmonary function
timeFrame: 2 weeks, 6 weeks and 12 weeks
measure: Number of Participants with respiratory complications
timeFrame: 2 weeks, 6 weeks and 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Hunter New England Health District
state: New South Wales
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred (Alfred Health)
state: Victoria
city: Wŏnju
country: Korea, Republic of
facility: Yonsei Wonju Severance Christian Hospital
state: Gangwon-do
city: Suwon si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Alfred
name: Silvana Marasco, Professor
role: PRINCIPAL_INVESTIGATOR
References: