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

Flail Chest Clinical Trial

— MatrixRIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810251
• Other study ID #: S08-001
• Status: Completed
• Phase: Phase 4
• First received: December 16, 2008
• Last updated: July 5, 2011
• Start date: December 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2011
• Source: Legacy Biomechanics Laboratory
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Flail Chest

Intervention

Device:
• MatrixRIB (FDA Approval # K081623)
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.

Locations

Country	Name	City	State
United States	Legacy Emanuel Hospital	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Legacy Biomechanics Laboratory	Synthes Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.		3 months post surgery	No
Secondary	Length of ICU stay and hospitalization.		up to 3 months	No
Secondary	Incidence of pneumonia, localized infection.		up to 3 months	No
Secondary	Duration of post-operative requirement for ventilatory support		up to 3 months	No
Secondary	Duration of post-operative medication for chest pain		up to 3 months	No
Secondary	RAND 36-Item Short Form Health Survey (SF-36)		3 months post surgery	No
Secondary	Intra-operative complications related to fixation hardware.		intra-operative	No