Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture
Summary
Individuals with non-healing rib fractures may experience significant pain and disability. This is called rib fracture non-union, an unusual problem and one that most physicians have little experience with. The investigators hypothesize that surgical repair of rib fracture non-union is clinically efficacious and safe in 6 month follow-up. The objective of this study is to evaluate how repairing non-healing rib fractures affects pain and disability.
Description
Rib fractures are a painful and disabling injury commonly found among trauma patients. According to the National Center for Health Statistics, approximately 350,000 people with rib fractures were treated in emergency and ambulatory care departments in the United States in the year 2006. 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. Investigators may use other FDA approved devices (i.e. BioBridge ™ Bioresorbable Bone Fracture Plate), or determine that no device is indicated (i.e. rib resection without hardware). The investigators expect to learn about clinical outcomes for surgical care in this group of patients, both with the use of a device, and without.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Conditions
Rib Fracture
Intervention
RibLoc ® Rib Fracture Plating System, BioBridge™Bioresorbable Bone Fracture Plate System Other: Operative management without a device.
Location
Oregon Health & Science University
Portland
Oregon
United States
97239
Status
Recruiting
Source
Oregon Health and Science University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00774618
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bone Plates
Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)
Fracture Fixation
The use of metallic devices inserted into or through bone to hold a fracture in a set position and alignment while it heals.
Fracture Healing
The physiological restoration of bone tissue and function after a fracture. It includes BONY CALLUS formation and normal replacement of bone tissue.
Monteggia's Fracture
Fracture in the proximal half of the shaft of the ulna, with dislocation of the head of the radius.
Skull Fractures
Fractures of the skull which may result from penetrating or nonpenetrating head injuries or rarely BONE DISEASES (see also FRACTURES, SPONTANEOUS). Skull fractures may be classified by location (e.g., SKULL FRACTURE, BASILAR), radiographic appearance (e.g., linear), or based upon cranial integrity (e.g., SKULL FRACTURE, DEPRESSED).
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