Flail Chest
Conditions
Keywords
rib fracture, flail chest, plate, chest trauma, osteosynthesis, mechanical ventilation, respirator
Brief summary
The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.
Detailed description
This is a multiple site, prospective, non-randomized single arm observational study. It has been designed to document the treatment of serial rib fractures with MatrixRIB implants in a registry. A flail chest is an injury in which three or more consecutive ribs are broken. This injury causes a segment of the chest wall to become unstable und prevents effective respiration. Non-operative management requires long-term mechanical ventilation and is associated with a mortality rate of 17-47%. Surgical stabilization of the rib fractures has shown to decrease this mortality by 38% - 72%. Surgical stabilization is typically performed with generic plates that require extensive bending during surgery to conform the plate to the rib in a difficult and time-consuming procedure. The MatrixRIB system is the first implant system that has been specifically designed for fixation of flail chest injuries. It has been developed at Legacy Health System, has been extensively tested in biomechanical studies, and has been approved by the FDA. It provides anatomically contoured rib plates that can reduce the time and complexity of intra-operative plate contouring. These plates will be used in the present study in place of generic plates. It furthermore provides intramedullary rib splints that enable less invasive fixation of posterior rib fractures that are difficult to access for plate fixation. The primary objective of this study is to document stabilization of flail chest injuries with MatrixRIB implants in a registry. Twenty consecutive patients with flail chest injury that receive surgical stabilization of rib fractures with MatrixRIB implants will be documented in the registry. Data collected will include baseline patient demographics, and information related to injury severity, surgical procedures, and post-operative recovery. The patients' functional outcome will be assessed up to the standard follow-up visit 3 months after surgery.
Interventions
DEVICEMatrixRIB (FDA Approval # K081623)
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
Sponsors
Synthes Inc.
Legacy Biomechanics Laboratory
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with mono-lateral or bi-lateral flail chest injury and paradoxical motion of the chest wall, whereby a flail chest is defined by three or more consecutive ribs broken in at least two locations. * Male and female patients, ages 21 to 80 years. * Able and willing to obtain informed consent from patient or next of kin. * Able and willing to adhere to 3-months follow-up visit
Exclusion criteria
* Pregnant women * Patients who are enrolled in another investigational treatment trial. * Severe closed head injury (AIS head \> 3) * Severe spinal injury with neurological deficit above thoraco-lumbar junction. * Chronic preexisting heart, pulmonary, hepatic, and/or renal disease. * Patients who are not expected to survive the follow-up period. * Patient with an acutely paralyzed hemidiaphragm. * Considered an inappropriate participant by the study physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery. | 3 months post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of pneumonia, localized infection. | up to 3 months |
| Duration of post-operative requirement for ventilatory support | up to 3 months |
| Length of ICU stay and hospitalization. | up to 3 months |
| RAND 36-Item Short Form Health Survey (SF-36) | 3 months post surgery |
| Intra-operative complications related to fixation hardware. | intra-operative |
| Duration of post-operative medication for chest pain | up to 3 months |
Countries
United States
Outcome results
None listed