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

Recruiting

• Conditions: Rib; Fracture
• Interventions: Device: Non surgical and Surgical

• Registration Number: NCT05146986
• Lead Sponsor: Zimmer Biomet

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.

Study Timeline

• Study First Submitted: 2021-10-15
• Study First Submitted QC: 2021-12-05
• Study First Posted: 2021-12-07
• Study Start: 2022-01-02
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Thoracic pain as assessed by numeric Rating Scale (NRS)	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,

Secondary Outcome Measures

Name	Time	Method
Length of Hospital stay	12 weeks	Length of Hospital stay by the difference groups
Pulmonary function	2 weeks, 6 weeks and 12 weeks	Pulmonary function will be assessed by the measuring the forced expiratory volume (FEV) using a spirometer.
Rate of Analgesic use	12 weeks	Analgesic use by the difference groups
Number of Participants with respiratory complications	2 weeks, 6 weeks and 12 weeks	Complications from the different groups assessed to be related to respiratory.
Quality of life using EuroQoL-5L	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

Trial Locations

Locations (5)

Hunter New England Health District; 🇦🇺 Sydney, New South Wales, Australia

Flinders Medical Centre; 🇦🇺 Bedford Park, South Australia, Australia

Yonsei Wonju Severance Christian Hospital; 🇰🇷 Wŏnju, Gangwon-do, Korea, Republic of

The Alfred (Alfred Health); 🇦🇺 Melbourne, Victoria, Australia

Ajou University Hospital; 🇰🇷 Suwon si, Gyeonggi-do, Korea, Republic of