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

NCT05146986 | Recruiting FDA Device

• 1 other identifier: CSA2021-16SU
• Study Type: observational
• Target: 167
• Locations: 2 countries
• Sites: 5

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.

Conditions

Rib; Fracture

Keywords

Non-flail chest

Outcome Measures

Primary Outcomes (1)

• Thoracic pain as assessed by numeric Rating Scale (NRS)

  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 Outcomes (6)

• Rate of Analgesic use

  12 weeks

• Length of Hospital stay

  12 weeks

• Quality of life using EuroQoL-5L

  2 weeks, 6 weeks and 12 weeks

• Pulmonary function

  12 weeks

• Pulmonary function

  2 weeks, 6 weeks and 12 weeks

Study Arms (2)

Non-surgical group

Patients will receive analgesia and symptomatic management treatment

Device: Non surgical and Surgical

Surgical group

Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System

Device: Non surgical and Surgical

Interventions

Non surgical and Surgical DEVICE

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.

Non-surgical group; Surgical group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (5)

Hunter New England Health District

Sydney, New South Wales, 2301, Australia

NOT YET RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

The Alfred (Alfred Health)

Melbourne, Victoria, 31004, Australia

RECRUITING

Yonsei Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, 26426, South Korea

RECRUITING

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

RECRUITING

MeSH Terms

Conditions

Rib Fractures

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Study Officials

• Silvana Marasco, Professor

  The Alfred

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Chong

CONTACT

97566687; irene.chong@zimmerbiomet.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: December 7, 2021
• Study Start: January 2, 2022
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2); AU (3)