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

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

The purpose of this observational study is to document the treatment of serial rib fractures with MatrixRIB implants in a registry.

Study Overview

• Status: Completed
• Conditions: Flail Chest
• Intervention / Treatment: Device: MatrixRIB (FDA Approval # K081623)

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97227
      • Legacy Emanuel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Flail chest patients admitted to Level I and Level II trauma centers.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MatrixRIB	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 Names: rib plates

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.	3 months post surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Length of ICU stay and hospitalization.	up to 3 months
Incidence of pneumonia, localized infection.	up to 3 months
Duration of post-operative requirement for ventilatory support	up to 3 months
Duration of post-operative medication for chest pain	up to 3 months
RAND 36-Item Short Form Health Survey (SF-36)	3 months post surgery
Intra-operative complications related to fixation hardware.	intra-operative

Collaborators and Investigators

• Sponsor: Legacy Biomechanics Laboratory
• Collaborators: Synthes Inc.
• Investigators: Principal Investigator: Michael Bottlang, PhD, Legacy Clinical Research & Technology Center

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 16, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: mechanical ventilation; flail chest; osteosynthesis; rib fracture; chest trauma; plate; respirator
• Additional Relevant MeSH Terms: Wounds and Injuries; Flail Chest; Thoracic Injuries
• Other Study ID Numbers: S08-001