MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry

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.