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

December 16, 2008
July 5, 2011
December 2008
April 2011   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00810251 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Flail Chest
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
MatrixRIB
Intervention: Device: MatrixRIB (FDA Approval # K081623)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00810251
S08-001
No
Michael Bottlang, PhD, Director, Legacy Biomechanics Laboratory, Legacy Clinical Research & Technology Center
Legacy Biomechanics Laboratory
Synthes Inc.
Principal Investigator: Michael Bottlang, PhD Legacy Clinical Research & Technology Center
Legacy Biomechanics Laboratory
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP