Clinical trial NCT00810251: MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries: A Registry
Official title: A Multi-Site Prospective, Non-Randomized Observational Study Utilizing MatrixRIB Implants for Surgical Stabilization of Flail Chest Injuries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Flail Chest
Keywords: rib fracture
flail chest
plate
chest trauma
osteosynthesis
mechanical ventilation
respirator
Lead sponsor: Legacy Biomechanics Laboratory
Sponsor class: OTHER
Collaborators: name: Synthes Inc.
First posted: 2008-12-18
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Flail chest patients admitted to Level I and Level II trauma centers.

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

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 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.

Primary outcomes:
measure: Durable flail chest stabilization, resulting in effective chest wall function at three months post surgery.
timeFrame: 3 months post surgery
Secondary outcomes:
measure: Length of ICU stay and hospitalization.
timeFrame: up to 3 months
measure: Incidence of pneumonia, localized infection.
timeFrame: up to 3 months
measure: Duration of post-operative requirement for ventilatory support
timeFrame: up to 3 months
measure: Duration of post-operative medication for chest pain
timeFrame: up to 3 months
measure: RAND 36-Item Short Form Health Survey (SF-36)
timeFrame: 3 months post surgery
measure: Intra-operative complications related to fixation hardware.
timeFrame: intra-operative
Other outcomes:
Locations:
city: Portland
country: United States
facility: Legacy Emanuel Hospital
state: Oregon
Study officials:
affiliation: Legacy Clinical Research & Technology Center
name: Michael Bottlang, PhD
role: PRINCIPAL_INVESTIGATOR
References: