Clinical trial NCT01677000: Clinical Priority Program-Bone Infection Registry
Official title: Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Infection
Staphylococcus Aureus
Keywords: bone infection
staphylococcus aureus
registry
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 297
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with diagnosis of Staphylococcus aureus bone infection

Brief summary: 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.

Detailed description: Establish an international registry with AOCID 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. Creation of an AOCID Registry for musculoskeletal infection cases will permit better analysis of the causes, contributing factors including patient immune responses, treatments and clinical outcomes of musculoskeletal infections.

* Establish a practice network that includes ≥ 20 geographically distributed centers. These busy practices will be treating patients with varied geographic status to assure balanced representation of diverse patients and practices.
* Establish a Data Coordinating Core team with AOCID 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:

* baseline patient attributes
* surgical approach, implants and technology
* hospital course
* surgeon and institutional characteristics
* longitudinal patient outcome
* post-procedure complications and revisions
* serum/tissue/drainage samples

  * Establish a Statistical Support team with AOCID to implement cutting-edge statistical techniques including the use of hierarchical generalized linear latent and mixed effects models to address the complex structure and longitudinal nature of registry data. Multivariable predictive models for outcome(s) of infection will be developed.
  * Establish an Outcomes Measurement Team with AOCID and Investigators from the CPP team to advance the science of infection-specific and global patient-reported outcomes to support efficient data collection of web-based, longitudinal data in this registry and future comparative effectiveness research.
  * Develop new assessment tools and conduct research useful to clinical practice. Establish consensus on the definition of treatment failure- characterized as lack of clinically meaningful improvement in infection, pain or physical function following treatment, validate, and refine prediction algorithms for patients at risk for failure.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Details on occurence and treatment of bone infection
timeFrame: 1 December 2012
Secondary outcomes:
measure: Surgical approach, implants and technology
timeFrame: 01 December 2012
measure: Patient outcome
timeFrame: 01 December 2012
measure: Post-procedure complications and revisions
timeFrame: 01 December 2012
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Rochester
country: United States
facility: Unity Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Richmond
country: United States
facility: University of Richmond, Department of Orthopaedic Surgery
state: Virginia
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Innsbruck
country: Austria
facility: Medizinische Universitaetsklinik Innsbruck
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Chongqing
country: China
facility: Southwestern Hospital Chongqing
state: Chongqing
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Beijing
country: China
facility: Beijing University Third Hospital
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
city: Hong Kong
country: China
facility: Queen Mary Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Murnau am Staffelsee
country: Germany
facility: Berufsgenossenschaftliche Unfallklinik Murnau
state: Bavaria
city: Giessen
country: Germany
facility: Justus-Liebig-Universität
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Sapporo
country: Japan
facility: Hokkaido University Graduate School of Medicine
state: Hokkaido
city: Hiroshima
country: Japan
facility: Hamawaki Orthopaedic Hospital
city: Basel
country: Switzerland
facility: Universitätsspital Basel
state: Basel Stadt
Study officials:
affiliation: University of Richmond
name: Stephen L Kates, MD
role: PRINCIPAL_INVESTIGATOR
References: