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.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subjects must be at least 18 years of age 2. Subjects must have rib fracture non-union (3 months or greater since injury), confirmed with Chest CT or MRI 3. The subject will have signed an IRB approved written informed consent and HIPAA authorization to participate in the study 4. Subjects will be able to participate in interviews with study staff and complete study surveys reliably Exclusion Criteria: 1. Subjects who are enrolled in another investigational treatment trial 2. Subjects who have received an investigational drug or device within 30 days of enrollment 3. Female subjects who are pregnant |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | Oregon Health & Science University | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University | ACUTE Innovations, LLC |
United States,
Beelen R, Rumbaut J, De Geest R. Surgical stabilization of a rib fracture using an angle stable plate. J Trauma. 2007 Nov;63(5):1159-60. — View Citation
Cacchione RN, Richardson JD, Seligson D. Painful nonunion of multiple rib fractures managed by operative stabilization. J Trauma. 2000 Feb;48(2):319-21. — View Citation
Ng AB, Giannoudis PV, Bismil Q, Hinsche AF, Smith RM. Operative stabilisation of painful non-united multiple rib fractures. Injury. 2001 Oct;32(8):637-9. — View Citation
Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. Rib fracture repair: indications, technical issues, and future directions. World J Surg. 2009 Jan;33(1):14-22. doi: 10.1007/s00268-008-9770-y. — View Citation
Richardson JD, Franklin GA, Heffley S, Seligson D. Operative fixation of chest wall fractures: an underused procedure? Am Surg. 2007 Jun;73(6):591-6; discussion 596-7. — View Citation
Sales JR, Ellis TJ, Gillard J, Liu Q, Chen JC, Ham B, Mayberry JC. Biomechanical testing of a novel, minimally invasive rib fracture plating system. J Trauma. 2008 May;64(5):1270-4. doi: 10.1097/TA.0b013e31804a7fd5. — View Citation
Slater MS, Mayberry JC, Trunkey DD. Operative stabilization of a flail chest six years after injury. Ann Thorac Surg. 2001 Aug;72(2):600-1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of employment or disability status | At study entry (day 1) and 2 month intervals for up to 12 months. | No | |
Secondary | quality of life evaluation | (Rand 36-Item Short Form Health Survey) | At study entry (day 1) and 2 month intervals for up to 12 months. | No |
Secondary | an assessment of rib fracture pain | McGill Pain Questionnaire or MPQ | At study entry (day 1) and 2 month intervals for up to 12 months. | No |
Secondary | complications related to injury or treatment | At study entry (day 1) and 2 month intervals for up to 12 months. | No |
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