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Recruiting NCT05146986

RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

— Observational Rib; Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non surgical and Surgical.
Who it may be relevant to
Registry conditions: Rib; Fracture. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective Multi-center Comparative Study of RibFix Blu Thoracic Fixation System Versus Non-surgical Treatment in Non-flail Chest Rib Fractures

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Thoracic pain as assessed by numeric Rating Scale (NRS) [Time frame: 2 weeks]
Secondary outcome measures (6)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

Australia · 3 centers
  • Hunter New England Health District — Sydney
  • Flinders Medical Centre — Bedford Park
  • The Alfred (Alfred Health) — Melbourne
South Korea · 2 centers
  • Yonsei Wonju Severance Christian Hospital — Wŏnju
  • Ajou University Hospital — Suwon

Identifiers

NCT: NCT05146986 · CSA2021-16SU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗