MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry (MatrixRIB)
|ClinicalTrials.gov Identifier: NCT00810251|
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : July 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Flail Chest||Device: MatrixRIB (FDA Approval # K081623)||Phase 4|
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.
|Study Type :||Observational|
|Actual Enrollment :||20 participants|
|Official Title:||A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries|
|Study Start Date :||December 2008|
|Primary Completion Date :||April 2011|
|Study Completion Date :||May 2011|
Device: MatrixRIB (FDA Approval # K081623)
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.
Other Name: rib plates
- Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery. [ Time Frame: 3 months post surgery ]
- Length of ICU stay and hospitalization. [ Time Frame: up to 3 months ]
- Incidence of pneumonia, localized infection. [ Time Frame: up to 3 months ]
- Duration of post-operative requirement for ventilatory support [ Time Frame: up to 3 months ]
- Duration of post-operative medication for chest pain [ Time Frame: up to 3 months ]
- RAND 36-Item Short Form Health Survey (SF-36) [ Time Frame: 3 months post surgery ]
- Intra-operative complications related to fixation hardware. [ Time Frame: intra-operative ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00810251
|United States, Oregon|
|Legacy Emanuel Hospital|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Michael Bottlang, PhD||Legacy Clinical Research & Technology Center|