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Sponsors and Collaborators: |
Legacy Biomechanics Laboratory Synthes Inc. |
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Information provided by: | Legacy Biomechanics Laboratory |
ClinicalTrials.gov Identifier: | NCT00810251 |
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 |
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 |
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.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Bottlang, PhD | 503 413 5457 | mbottlan@lhs.org |
Contact: Steven M Madey, MD | 503 784 5088 | madey@summitdocs.com |
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 |
Principal Investigator: | Michael Bottlang, PhD | Legacy Clinical Research & Technology Center |
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 History of Changes |
Health Authority: | United States: Institutional Review Board |
rib fracture flail chest plate chest trauma |
osteosynthesis mechanical ventilation respirator |
Thoracic Injuries Rib Fractures Fractures, Bone |
Wounds and Injuries Disorders of Environmental Origin Flail Chest |
Thoracic Injuries Wounds and Injuries Disorders of Environmental Origin Flail Chest |