Chronic Osteomyelitis
Conditions
Keywords
high resolution ultrasound, osteomyelitis
Brief summary
The purpose of this study is to establish the sensitivity of HRUS as compared to MRI for the diagnosis of osteomyelitis in chronic wound patients; and to determine the specificity of HRUS as compared to pathologic and microbiologic studies of bone biopsy tissues.
Interventions
DEVICEHitachi-Aloka Noblus ultrasound scanner
High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer
DEVICEMagnetic Resonance Imaging (MRI)
MRI with or without contrast
Sponsors
Calvary Hospital, Bronx, NY
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patient may be of any race and between 18-85 years of age. 2. Patient has a current diagnosis of a chronic ulcer with suspected osteomyelitis. 3. Patient's ulcer may be due to any etiology including but not limited to diabetes, trauma, neuropathic, pressure, venous, arterial, and inflammatory. 4. Patient's ulcer may extend through the dermis and into subcutaneous tissue (granulation tissue may be present), and may include exposure of muscle, tendon, bone, or joint capsule. 5. Patient's ulcer is suspected of causing a bone infection. 6. Patient's ulcer may be of any size. 7. Patient's wound may present with non-viable tissue. 8. Patient circulation to the wound should be evaluated and treated using normal protocol. 9. Patient's diabetes is under control as determined by the Investigator. Patients must have an HbA1c value less than 13.0%. Those patients whose glucose level is not deemed to be in control should be referred to their primary physician for treatment of the hyperglycemia. 10. Patient and caregiver are willing to participate in the clinical study and comply with the follow-up regimen. 11. Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment. 12. If patient is capable of childbirth, she is using medically accepted means of birth control, and she tests negative on a serum pregnancy test. 13. Active localized acute wound infection or cellulitis: Subject may be considered for study enrollment after the signs and symptoms of acute infection have resolved.
Exclusion criteria
1. Subject has a condition where an MRI is contraindicated * Metallic fragments, clips or devices in the brain, eye, spinal canal, etc.: (Plain radiography is sufficient for screening * Magnetically activated implanted devices: Cardiac pacemakers, insulin pumps, neuro¬stim¬u¬lators, cochlear implants, etc. may be de-programmed. * Non-graphite spinal cord tongs: Graphite tongs are compatible. * Thermodilution Swan-Ganz catheter: Local heating can result. If unenhanced MRI is likely to provide sufficient information, gadolinium should not be administered to these patients. If, after review of clinical indications, gadolinium enhancement is judged to be important for diagnosis, the lowest effective dose of contrast agent should be used. 2. In subjects where gadolinium enhancement MRI is planned then the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent sensitivity and specificity of HRUS as compared to MRI and bone biopsy | at 3 weeks |
Countries
United States
Outcome results
None listed