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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Evaluation of the U-plate Fracture Repair System for the Fixation of Rib Fractures

Brief Summary:

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.

Detailed Summary:

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.

Current Primary Outcome:

• Adverse Post-op Events Related to the Repair and Plating System [ Time Frame: 180 days ]
  Clinical evaluations or chest radiographs at a minimum of 1 and 6 months
• 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 ]
  The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
• 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 ]
  The RAND 36-Item Short Form Health Survey measures physical and mental health. Study subjects completed the questionnaire at 2 month intervals for 6 months to evaluate net change over time. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning. Aggregate scores are compiled as a percentage of the total points possible, using a RAND scoring table. This health survey was developed at Rand Health as part of the Medical Outcomes Study.
• The Rand 36-Item Health Survey Results - Role Limitations - Emotional Scale [ Time Frame: results at 60, 120, and 180 days post-re
  
  

  Original Primary Outcome: 1. Number of days lost from work or usual activities 2. The SF-36® Health Survey results 3. The McGill Pain Questionnaire (MPQ) 4. complications related to injury or treatment [ Time Frame: 1. Time frame: from date of injury / post injury day # and from repair of injury / post-op day #; 2. Time frame: results at 60, 120, and 180 days post-repair; 3. Time frame: results at 60, 120, and 180 days post-repair ]
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: Oregon Health and Science University
  

  Dates:
  Date Received: November 9, 2007
  Date Started: November 2006
  Date Completion:
  Last Updated: June 7, 2011
  Last Verified: June 2011