NCT00810251

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

A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Legacy Biomechanics Laboratory · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Flail Chest

Interventions

Type	Name	Description
DEVICE	MatrixRIB (FDA Approval # K081623)	MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.

Timeline

• Start date: 2008-12-01
• Primary completion: 2011-04-01
• Completion: 2011-05-01
• First posted: 2008-12-18
• Last updated: 2011-07-06

Locations

1 site across 1 country: United States