• Outcome measures will evaluate employment or disability status, a quality of life evaluation (Rand 36-Item Short Form Health Survey),an assessment of rib fracture pain (McGill Pain Questionnaire or MPQ), and complications related to injury or treatment. [ Time Frame: At study entry and 2 month intervals for up to 12 months ] [ Designated as safety issue: Yes ]
  

Device: Device: RibLoc ™ (U-plate) Fracture Repair System
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 (RibLoc ™). The design of the RibLoc ™ 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.

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 2004.1 The Healthcare Cost and Utilization Project's Nationwide Inpatient Sample for the year 2003 indicated that 102,000 patients with rib fractures were admitted to U.S. hospitals, representing 7 % of all injured patients.

Within the past decade a subgroup of patients with symptomatic rib fracture non-unions has been identified. These are patients who present to primary care physicians and surgical clinics more than 3 months, or in some cases several years, following a rib fracture injury with complaints of rib pain associated with persistent fracture movement. They are usually told by their physician that surgical intervention is either unnecessary or fruitless and are treated with chronic pain management regimens. The true incidence and the long-term outcome of this syndrome are completely unknown.

At OHSU, we have had a long interest in the indications for and the outcomes of rib fracture repair. One of the first of three nearly simultaneous reports of successful surgical intervention of symptomatic rib fracture non-union originated here at OHSU in 2001. Two other successful case reports have appeared more recently. We are currently being contacted frequently by patients or their physicians, mostly out of state, for consideration of rib fracture non-union repair. Our ongoing experience with rib fracture non-union repair has been favorable, but we believe that a prospective clinical study with at least 6 months of post-operative outcome is necessary. In addition, because the insurance company approval process for surgical intervention for rib fracture non-union is often 2 - 3 months and occasionally longer, we have an opportunity to follow the intermediate-term natural history of rib fracture non-unions for several months prior to surgical intervention.

The rationale for conducting this study is to demonstrate in a prospective study that the RibLoc ™ repair system is durable and safe in a population of patients with rib fracture non-union. Although this clinical outcome data is not required by the FDA to market and implant this prosthesis, the investigators believe that to establish the clinical benefit of the RibLoc ™ device for non-union repair, prospectively collected outcome data are necessary.