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Efficacy of MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries
This study is currently recruiting participants.
Verified by Legacy Biomechanics Laboratory, December 2008
Sponsors and Collaborators: Legacy Biomechanics Laboratory
Synthes Inc.
Information provided by: Legacy Biomechanics Laboratory
ClinicalTrials.gov Identifier: NCT00810251
  Purpose

The purpose of this study is to compile information on the efficacy of surgical stabilization of serial rib fractures with MatrixRIB implants.

Hypothesis: MatrixRIB implants provide for effective and safe stabilization of serial rib fractures. Specifically, anatomic MatrixRIB plates will eliminate the intra-operative need for plate contouring, and MatrixRIB splints enable intramedullary stabilization of posterior rib fractures that cannot be reached for plating.


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

MedlinePlus related topics: Fractures
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Multi-Site Prospective, Non-Randomized Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: Analysis of Clinical Efficacy

Further study details as provided by Legacy Biomechanics Laboratory:

Primary Outcome Measures:
  • Effective flail chest stabilization, resulting in pain-free chest wall function (PFSDQ-M pulmonary function questionnaire) 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 ]
  • SF-26 Health survey [ 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 ]

Estimated Enrollment: 20
Study Start Date: December 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MatrixRIB: Experimental Device: MatrixRIB (FDA Approval # K081623)
MatrixRIB implants are comprised of anatomic rib plates and intramedullary rib splints for internal surgical stabilization of rib fractures.

Detailed Description:

This is a multiple site, prospective, non-randomized single arm outcome study. It has been designed to compile information on the efficacy of surgical stabilization of flail chest injuries with MatrixRIB implants. 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 assess the efficacy of surgical stabilization of flail chest injuries with MatrixRIB implants. Twenty consecutive patients with flail chest injury will receive surgical stabilization of rib fractures with MatrixRIB implants. Data collected during this study 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:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 18 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810251

Contacts
Contact: Michael Bottlang, PhD 503 413 5457 mbottlan@lhs.org
Contact: Steven M Madey, MD 503 784 5088 madey@summitdocs.com

Locations
United States, Oregon
Legacy Emanuel Hospital Recruiting
Portland, Oregon, United States, 97227
Contact: Steven M Madey, MD     503-784-5088     madey@summitdocs.com    
Contact: William B Long, MD     503 413 ext 2101     wlong@lhs.org    
Principal Investigator: William B Long, MD            
Sub-Investigator: Steven M Madey, MD            
Sponsors and Collaborators
Legacy Biomechanics Laboratory
Synthes Inc.
Investigators
Principal Investigator: Michael Bottlang, PhD Legacy Clinical Research & Technology Center
  More Information

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

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

Study placed in the following topic categories:
Thoracic Injuries
Rib Fractures
Fractures, Bone
Wounds and Injuries
Disorders of Environmental Origin
Flail Chest

ClinicalTrials.gov processed this record on January 14, 2009