AzTrials
AzTrials

OsteomyelitisNCT01612962

Diagnostic Tests to Help Determine Osteomyelitis

An observational study of Osteomyelitis, run by Georgetown University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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

Other trials in United States

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 groups in NCT01612962
Study groupRoleWhat they receive
bony debridement or amputationIn 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.

  1. 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)
  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.

  1. First posted6 Jun 2012 (estimated)
  2. Study startMay 2011
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

Resources

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)
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

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in