Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Prospective Trial of Operative Management of Rib Fracture Non-Union|
- Evaluation of employment or disability status [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]
- quality of life evaluation [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ](Rand 36-Item Short Form Health Survey)
- an assessment of rib fracture pain [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]McGill Pain Questionnaire or MPQ
- complications related to injury or treatment [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Those subjects undergoing resection with or without plate fixation
Device: Resection with or without plate fixation
Some enrolled subjects will undergo rib fracture surgery at OHSU. Devices used in the repair of rib fracture non-union could include RibLoc® or BioBridge ™. RibLoc® is a U-shaped permanent device that secures to the rib with screws locking from the front to the back of the metal plate (through the rib). BioBridge ™ is a resorbable, non-permanent device that stabilizes the ribs. Both devices are designed to stabilize the rib fracture non-union and promote healing of the non-union rib. For some patients, it may be determined that resection of the rib fracture non-union without an implanted device is the most appropriate treatment. The goal of surgical intervention is to improve the pain and disability associated with rib fracture non-union in appropriate patients.
No Intervention: Nonoperative
These patients were not considered candidates for surgical intervention by the investigators, declined surgical intervention, or did not receive insurance approval for surgery
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00774618
|United States, Oregon|
|Oregon Health & Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||John C Mayberry, MD, FACS||Oregon Health and Science University|