Clinical Study of the U-Plate Fracture Repair System to Treat Rib Fractures

Status: Completed
Study State Date: November 2006
Primary Completion Date: Actual October 2008
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase: N/A

Sponsor(s):
Oregon Health and Science University
ACUTE Innovations, LLC
 
Information By: Oregon Health and Science University
Trial Identifier: NCT00556543
Official Title: Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures

Description:  The purpose of this study is to gather information about a device used to help fix broken ribs. Hypothesis: Rib fracture repair with the U-plate system is clinically durable and safe for the indications of flail chest repair, acute pain control, chest wall defect repair, and rib fracture non-union.

+ Additional Objectives Detail

Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 300,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2004. Rib fracture patients are significantly more disabled at 30 days post-injury than patients with chronic medical illness and lose an average of 70 days of work or usual activity during their acute recovery. The rationale for conducting this study is to demonstrate in a prospective study that the U-plate repair system is durable and safe. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that in order for the U-plate to be widely accepted, prospectively collected outcome data are necessary. With the goal of improving the durability of fixation of rib fractures over the techniques currently available and with the additional goal of developing a minimally invasive technique, a U-shaped plate was developed. The design of the U-plate theoretically overcomes the inherent softness of the human rib by grasping the rib over its superior margin and by securing the plate with anterior to posterior locking screws that do not rely on screw purchase in bone. Thus much of the strength and durability of the fixation is transferred from the relatively soft rib to the plate itself.



Accepts Healthy Volunteers?: No
Enrollment: 10 Actual
Minimum Age: 18 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  Inclusion Criteria: - Subjects must be at least 18 years of age - Subjects must have one of the four clinical indications listed below: 1. Flail chest with failure to wean from ventilator (> 5 days post-injury) and Paradoxical chest wall movement visualized; no significant pulmonary contusion and no significant brain injury 2. Painful, displaced rib fractures (acute pain control) and failure of narcotics or epidural pain catheter to control pain; fracture movement exacerbates pain (after 7 - 10 days) and minimal associated injuries 3. Chest wall defect/severely displaced fractures and non-repair defect may result in pulmonary hernia and severely displaced fractures are significantly impeding lung expansion in hemi-thorax 4. Symptomatic rib fracture non-union and CT scan evidence of fracture non-union at least 2 months post-injury Exclusion Criteria: - Subjects who are enrolled in another investigational treatment trial - Subjects who have received an investigational drug or device within 30 days of enrollment - Subjects who are unable to complete the follow-up questionnaires - Subjects with severe head injuries or other severe associated injuries - Subjects who are not expected to survive the follow-up period - Female subjects who are pregnant - Non-English or English as Second Language speakers

Conditions:
Rib Fractures
Rib Fracture
Fractures, Bone
Flail Chest
Interventions:
Device: U-plate fracture repair system
 
Primary Outcome Measures:
Adverse Post-op Events Related to the Repair and Plating System
Time Frame: 180 days
Safety Issue: Yes

The Rand 36-Item Health Survey Results - Physical Functioning Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Role Limitations - Physical Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Vitality Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Emotional Well-being Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Social Functioning Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - Bodily Pain Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The Rand 36-Item Health Survey Results - General Health Scale
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The McGill Pain Questionnaire (MPQ) - Present Pain Intensity (PPI)
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

The McGill Pain Questionnaire (MPQ) - Pain Rating Index (PRI)
Time Frame: results at 60, 120, and 180 days post-repair with results posted for 180 days
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Treatment: Other
Device: U-plate fracture repair system
All subjects meeting inclusion criteria will undergo surgery for the repair of their fractured rib/s using the U-plate device. Subjects will be monitored daily during the entire course of their hospitalization for adverse experiences. Subjects will be contacted by phone to complete the MPQ and SF-36 Health Survey. Subjects will be asked if and when they have returned to work or to their previous level of functioning. Subjects will be asked if they had any complications or problems associated with their surgery.

 


Investigators:
Principal Investigator: John C. Mayberry, MD, Oregon Health and Science University

Responsible Party:
Oregon Health & Science University (John Mayberry, MD)

Study Locations:
+ Show All 1 Study Locations


United States, Oregon
Oregon Health & Science University 
Portland, Oregon, United States

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