Diagnostic Tests to Help Determine Osteomyelitis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
John Steinberg, DPM, Georgetown University
ClinicalTrials.gov Identifier:
NCT01612962
First received: May 30, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition
Osteomyelitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Diagnostic Tests to Help Determine Osteomyelitis: an Analysis and Comparison of Clinical Signs, Microbiology, Pathology and Radiology.

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • Accuracy of Osteomyelitis Diagnostic Testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Reliability of diagnostic testing for Osteomyelitis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To find a test that is the most reliable in determining osteomyelitis


Estimated Enrollment: 1000
Study Start Date: May 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
bony debridement or amputation
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

Detailed Description:

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]. Senneville et al. attempted to define the true correlation between cultures of swab samples and cultures of bone biopsy specimens obtained from areas of osteomyelitis in the diabetic foot. It was found that swab cultures are inaccurate and unreliable indicators of the pathogenic organism in chronic diabetic foot osteomyelitis and there was overall poor concordance between the superficial swab culture and bone biopsy culture results for all microorganisms [8].

Other methods for diagnosing osteomyelitis include radiographic analysis. On plain film, osteomyelitis is suspected when one or more of the following radiographic signs is observed: periosteal elevation, cortical disruption, medullary involvement, osteolysis, and sequestra (segments of necrotic bone separated from living bone by granulation tissue) [9]. Signs of osteomyelitis only show up on plain film 10-20 days after infection, [10, 11]. Dinh et al, in their meta-analysis on radiographic modalities, found 54% sensitivity and 68% specificity in detecting osteomyelitis with plain film versus 90% sensitivity and 79% specificity with MRI [12].

To the investigators' knowledge, there has been no study that compares all these methods to determine if there is a superior test to determine osteomyelitis.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger

Criteria

Inclusion Criteria:

  • Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612962

Locations
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20007
Sponsors and Collaborators
Georgetown University
Investigators
Principal Investigator: John J. Steinberg, DPM Georgetown University Hospital
Study Director: Paul Kim, DPM Georgetown University Hospital
  More Information

No publications provided

Responsible Party: John Steinberg, DPM, Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT01612962     History of Changes
Other Study ID Numbers: 2011-316
Study First Received: May 30, 2012
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Osteomyelitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014