OsteomyelitisNCT01612962
Diagnostic Tests to Help Determine Osteomyelitis
An observational study of Osteomyelitis, run by Georgetown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
About this study
Official title: Diagnostic Tests to Help Determine Osteomyelitis: an Analysis and Comparison of Clinical Signs, Microbiology, Pathology and Radiology.
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.
Read the 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.
- Conditions
- Osteomyelitis
- Medical subject headings
- Osteomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Osteomyelitis Diagnostic Testing
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.
Measured: 12 months
Secondary outcomes (1)
Reliability of diagnostic testing for Osteomyelitis
To find a test that is the most reliable in determining osteomyelitis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Steinberg, DPM, Georgetown University
- Investigators
- John J. Steinberg, DPM, Principal investigator, Georgetown University HospitalPaul Kim, DPM, Study director, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612962
- Sponsor's protocol ID
- 2011-316
- Status last verified
- Feb 2014
- First submitted
- 30 May 2012
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Tests to Help Determine Osteomyelitis: an Analysis and Comparison of Clinical Signs, Microbiology, Pathology and Radiology.
- ClinicalTrials.gov ID
- NCT01612962
- Acronym / sponsor ID
- 2011-316
- Conditions
- Osteomyelitis
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients that underwent a bony debridement or amputation in the operating room at Georgetown University Hospital during 2009-2010 under Drs. Steinberg and Attinger
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
1 secondary outcome
Reliability of diagnostic testing for Osteomyelitis
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J. Steinberg, DPM principal investigator
Georgetown University Hospital
Paul Kim, DPM study director
Georgetown University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteomyelitis, run by Georgetown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Osteomyelitis Diagnostic Testing (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2015.