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

This study has been completed.
Sponsor:
Collaborator:
Synthes Inc.
Information provided by:
Legacy Biomechanics Laboratory
ClinicalTrials.gov Identifier:
NCT00810251
First received: December 16, 2008
Last updated: July 5, 2011
Last verified: July 2011
  Purpose

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


Condition Intervention Phase
Flail Chest
Device: MatrixRIB (FDA Approval # K081623)
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries

Resource links provided by NLM:


Further study details as provided by Legacy Biomechanics Laboratory:

Primary Outcome Measures:
  • Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery. [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of ICU stay and hospitalization. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Incidence of pneumonia, localized infection. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Duration of post-operative requirement for ventilatory support [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • Duration of post-operative medication for chest pain [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
  • RAND 36-Item Short Form Health Survey (SF-36) [ Time Frame: 3 months post surgery ] [ Designated as safety issue: No ]
  • Intra-operative complications related to fixation hardware. [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2008
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: rib plates

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810251

Locations
United States, Oregon
Legacy Emanuel Hospital
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Legacy Biomechanics Laboratory
Synthes Inc.
Investigators
Principal Investigator: Michael Bottlang, PhD Legacy Clinical Research & Technology Center
  More Information

No publications provided

Responsible Party: Michael Bottlang, PhD, Director, Legacy Biomechanics Laboratory, Legacy Clinical Research & Technology Center
ClinicalTrials.gov Identifier: NCT00810251     History of Changes
Other Study ID Numbers: S08-001
Study First Received: December 16, 2008
Last Updated: July 5, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Legacy Biomechanics Laboratory:
rib fracture
flail chest
plate
chest trauma
osteosynthesis
mechanical ventilation
respirator

Additional relevant MeSH terms:
Flail Chest
Thoracic Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 20, 2014