Clinical Priority Program-Bone Infection Registry

Completed

Conditions studied: Bone Infection, Staphylococcus Aureus

In brief

Establish an international registry of over 400 patients with deep infections involving the bone and/or joint from≥20 centers representing all regions of the world with varied hospital and surgeon practice settings to ensure that registry analyses and research reflect typical clinical practice thereby providing optimal guidance for patients, clinicians, and healthcare researchers. Using a data collection platform that minimizes entry burden, collects most information at the time of surgery, and uses Internet technology to minimize data entry. The registry will include: 1. baseline patient attributes; 2. surgical approach, implants and technology; 3. hospital course; 4. surgeon and institutional characteristics; 5. longitudinal patient outcome, 6. post-procedure complications and revisions, 7. serum/tissue/drainage samples.

Key facts

Study ID

NCT01677000

Run by

AO Clinical Investigation and Publishing Documentation

People needed

297

Starts

2012-06-01

Expected to finish

2019-06-30

Last updated by the study team

2020-08-13

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18 years or older
• Confirmed* oxacillin-/methicillin-sensitive Staphylococcus aureus (OSSA/ MSSA) or methicillin resistant Staphylococcus aureus (MRSA) infection involving a long bone (ie, femur, tibia, fibula, humerus, radius, ulna, and clavicle) with one (or a combination) of the following:
• Osteomyelitis
• Fracture fixation hardware /prosthetic joint infection
• Infection around an arthroplasty
• Ability to understand the content of the patient information / informed consent form and to participate in the clinical investigation
• Signed written informed consent * Confirmed either by positive culture from baseline examination or by positive culture from a prior examination of the same surgical site and definitely ongoing infection with Staphylococcus aureus according to the treating surgeon

You may not qualify if…

• Patients who cannot give informed consent
• Patients who cannot attend the follow up visits
• Recent history of substance abuse (ie, recreational drugs, alcohol) that would preclude reliable assessment
• Prisoner

Where it is running

• University of Missouri Health Care — Columbia, Missouri, United States
• Unity Hospital — Rochester, New York, United States
• University of Rochester — Rochester, New York, United States
• Geisinger Health System — Danville, Pennsylvania, United States
• University of Richmond, Department of Orthopaedic Surgery — Richmond, Virginia, United States
• Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
• Medizinische Universitaetsklinik Innsbruck — Innsbruck, Austria
• Universitair Ziekenhuis Leuven — Leuven, Belgium
• Foothills Medical Centre — Calgary, Alberta, Canada
• Southwestern Hospital Chongqing — Chongqing, Chongqing Municipality, China
• Affiliated Hospital of Zunyi Medical College — Zunyi, Guizhou, China
• Beijing University Third Hospital — Beijing, China
• Zhejiang Provincial People's Hospital — Hangzhou, China
• Queen Mary Hospital — Hong Kong, China
• Aarhus University Hospital — Aarhus, Denmark
• Berufsgenossenschaftliche Unfallklinik Murnau — Murnau am Staffelsee, Bavaria, Germany
• Justus-Liebig-Universität — Giessen, Germany
• Universitaetsklinikum Regensburg — Regensburg, Germany
• Hokkaido University Graduate School of Medicine — Sapporo, Hokkaido, Japan
• Hamawaki Orthopaedic Hospital — Hiroshima, Japan
• Universitätsspital Basel — Basel, Canton of Basel-City, Switzerland

Full record on ClinicalTrials.gov

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