Clinical Trial: Evaluation of Surgical Treatment on Pain and Disability for Chronic, Non-healing Rib Fracture

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

Official Title: Prospective Trial of Operative Management of Rib Fracture Non-Union

Brief 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.

Detailed Summary:

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 approv
Sponsor: Oregon Health and Science University

Current Primary Outcome: Evaluation of employment or disability status [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ]

Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • quality of life evaluation [ Time Frame: At study entry (day 1) and 2 month intervals for up to 12 months. ]
    (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. ]
    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. ]


Original Secondary Outcome:

Information By: Oregon Health and Science University

Dates:
Date Received: October 16, 2008
Date Started: October 2008
Date Completion:
Last Updated: March 20, 2013
Last Verified: March 2013