Rib Fracture Clinical Trial
Official title:
Prospective Trial of Operative Management of Rib Fracture Non-Union
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.
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, the investigators 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. The investigators 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 the investigators 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, the investigators 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.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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