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

Zimmer Biomet

Status: Enrolling

Conditions: Rib; Fracture

Treatments: Device: Non surgical and Surgical

Study type: Observational

Funder types: Industry

Identifiers

NCT05146986

CSA2021-16SU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 167 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

167 participants in 2 patient groups

Non-surgical group

Description:

Patients will receive analgesia and symptomatic management treatment

Treatment:

Device: Non surgical and Surgical

Surgical group

Description:

Patients will receive surgical treatment using RibFix Blu Thoracic Fixation System

Treatment:

Device: Non surgical and Surgical