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

NCT ID: NCT00810251

Last Updated: 2011-07-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Flail Chest

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MatrixRIB

MatrixRIB (FDA Approval # K081623)

Intervention Type: DEVICE

MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.

Interventions

MatrixRIB (FDA Approval # K081623)

MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.

Intervention Type: DEVICE

Other Intervention Names

rib plates

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Synthes Inc.

INDUSTRY

Sponsor Role: collaborator

Legacy Biomechanics Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Legacy Clinical Research & Technology Center

Principal Investigators

Michael Bottlang, PhD

Role: PRINCIPAL_INVESTIGATOR

Legacy Clinical Research & Technology Center

Locations

Legacy Emanuel Hospital

Portland, Oregon, United States

Countries

United States

Other Identifiers

S08-001

Identifier Type: -

Identifier Source: org_study_id