Clinical Trial: Diagnostic Tests to Help Determine Osteomyelitis

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Diagnostic Tests to Help Determine Osteomyelitis: an Analysis and Comparison of Clinical Signs, Microbiology, Pathology and Radiology.

Brief Summary: In this study, the investigators will perform a retrospective chart analysis of patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger. Chart reviews, medical records and operative reports via EMR and paper charts will be examined from inpatient records, the Center for Wound Healing, the Emergency Department as well as other institutions involved in the care of the subjects to gather data.

Detailed Summary:

Osteomyelitis is present in approximately 20% of cases of foot infection in persons with diabetes [1, 2] and greatly increases the likelihood that the patient will require a lower-extremity amputation [3, 4]. Early diagnosis and treatment drastically improves prognosis. While there are multiple modalities through which osteomyelitis is diagnosed, unfortunately there is no definitive method. Bone biopsy with histopathological and microbiological analysis has been deemed the gold standard for diagnosing osteomyelitis [3, 5].

Osteomyelitis is considered proven if one or more pathogens are cultured from a reliably obtained bone specimen that shows bone death, acute or chronic inflammation and reparative responses on histological examination. However, histological analysis can also produce falsely positive results based on sampling error or if there are other causes of inflammation [6]. Furthermore, a recent study done by Meyr et al. has highlighted a discrepancy amongst pathologists that leaves the medical community questioning the validity of some pathological diagnoses.

Microbiological analysis can differ based on specimen processing and is also dependent on sampling technique. Often results can be falsely negative because of sampling error, prior antibiotic therapy, or inability to culture fastidious organisms; likewise, they may be falsely positive because of contamination by wound-colonizing flora [6].

Also, cultures of superficial swab samples from diabetic ulcers and sinus tracts may not adequately identify the true bacteriological characteristics of diabetic foot osteomyelitis because of bacterial colonization of the wound surfaces with microorganisms that are typically not considered to be pathogenic (such as enterococci and coagulase-negative staphylococci) [7]. Senne
Sponsor: Georgetown University

Current Primary Outcome: Accuracy of Osteomyelitis Diagnostic Testing [ Time Frame: 12 months ]

The purpose of this study is to help compare accuracy of all the diagnostic tests that are used in current practice to help determine osteomyelitis.


Original Primary Outcome: Same as current

Current Secondary Outcome: Reliability of diagnostic testing for Osteomyelitis [ Time Frame: 12 months ]

To find a test that is the most reliable in determining osteomyelitis


Original Secondary Outcome: Same as current

Information By: Georgetown University

Dates:
Date Received: May 30, 2012
Date Started: May 2011
Date Completion:
Last Updated: February 5, 2015
Last Verified: February 2014