Primary Outcome Measures:
- Effective flail chest stabilization, resulting in pain-free chest wall function (PFSDQ-M pulmonary function questionnaire) at three months post surgery. [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Length of ICU stay and hospitalization. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- Incidence of pneumonia, localized infection. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- Duration of post-operative requirement for ventilatory support [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- Duration of post-operative medication for chest pain [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- SF-26 Health survey [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
- Intra-operative complications related to fixation hardware. [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
This is a multiple site, prospective, non-randomized single arm outcome study. It has been designed to compile information on the efficacy of surgical stabilization of flail chest injuries with MatrixRIB implants. 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 assess the efficacy of surgical stabilization of flail chest injuries with MatrixRIB implants. Twenty consecutive patients with flail chest injury will receive surgical stabilization of rib fractures with MatrixRIB implants. Data collected during this study 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.