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

March 5, 2024 updated by: Zimmer Biomet

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

167

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2301
        • Not yet recruiting
        • Hunter New England Health District
        • Contact:
          • Zsolt Janos Balogh
        • Principal Investigator:
          • Zsolt Janos Balogh
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Gregory David Rice, MD
        • Principal Investigator:
          • Gregory David Rice
    • Victoria
      • Melbourne, Victoria, Australia, 31004
  • Korea, Republic of
    • Gangwon-do
      • Wŏnju, Gangwon-do, Korea, Republic of, 26426
        • Recruiting
        • Yonsei Wonju Severance Christian Hospital
        • Contact:
          • Chun
        • Principal Investigator:
          • Sung Byun Chun
    • Gyeonggi-do
      • Suwon si, Gyeonggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Jong Hwan Moon
        • Principal Investigator:
          • Jong Hwan Moon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-surgical group
Patients will receive analgesia and symptomatic management treatment
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.
Surgical group
Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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,
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Analgesic use
Time Frame: 12 weeks
Analgesic use by the difference groups
12 weeks
Length of Hospital stay
Time Frame: 12 weeks
Length of Hospital stay by the difference groups
12 weeks
Quality of life using EuroQoL-5L
Time Frame: 2 weeks, 6 weeks and 12 weeks

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
2 weeks, 6 weeks and 12 weeks
Pulmonary function
Time Frame: 12 weeks
Pulmonary function will be assessed by the measuring the forced vital capacity (FVC) using a spirometer.
12 weeks
Pulmonary function
Time Frame: 2 weeks, 6 weeks and 12 weeks
Pulmonary function will be assessed by the measuring the forced expiratory volume (FEV) using a spirometer.
2 weeks, 6 weeks and 12 weeks
Number of Participants with respiratory complications
Time Frame: 2 weeks, 6 weeks and 12 weeks
Complications from the different groups assessed to be related to respiratory.
2 weeks, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Principal Investigator: Silvana Marasco, Professor, The Alfred

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

December 5, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA2021-16SU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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