Clinical Priority Program-Bone Infection Registry (CPPInfection)

Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts

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.

Study Overview

• Status: Completed
• Conditions: Staphylococcus Aureus; Bone Infection

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.

• Study Type: Observational
• Enrollment (Actual): 297

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Hospital Italiano de Buenos Aires
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitaetsklinik Innsbruck
• Belgium
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Leuven
• Canada
  • Alberta
    • Calgary, Alberta, Canada, AB T2N 2T9
      • Foothills Medical Centre
• China
  • Beijing, China, 100191
    • Beijing University Third Hospital
  • Hangzhou, China, 310014
    • Zhejiang Provincial People's Hospital
  • Hong Kong, China
    • Queen Mary Hospital
  • Chongqing
    • Chongqing, Chongqing, China, 400038
      • Southwestern Hospital Chongqing
  • Guizhou
    • Zunyi, Guizhou, China, 56003
      • Affiliated Hospital of Zunyi Medical College
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
• Germany
  • Giessen, Germany, 35592
    • Justus-Liebig-Universität
  • Regensburg, Germany, 93042
    • Universitaetsklinikum Regensburg
  • Bavaria
    • Murnau am Staffelsee, Bavaria, Germany, 82418
      • Berufsgenossenschaftliche Unfallklinik Murnau
• Japan
  • Hiroshima, Japan, 730-0051
    • Hamawaki Orthopaedic Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8638
      • Hokkaido University Graduate School of Medicine
• Switzerland
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4031
      • Universitatsspital Basel
• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health Care
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
    • Rochester, New York, United States, 14626
      • Unity Hospital
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Health System
  • Virginia
    • Richmond, Virginia, United States, 23298
      • University of Richmond, Department of Orthopaedic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with diagnosis of Staphylococcus aureus bone infection

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Details on occurence and treatment of bone infection	1 December 2012

Secondary Outcome Measures

Outcome Measure	Time Frame
Surgical approach, implants and technology	01 December 2012
Patient outcome	01 December 2012
Post-procedure complications and revisions	01 December 2012

Collaborators and Investigators

• Sponsor: AO Clinical Investigation and Publishing Documentation
• Investigators: Principal Investigator: Stephen L Kates, MD, University of Richmond

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: August 29, 2012
• First Posted (Estimate): August 31, 2012

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: staphylococcus aureus; registry; bone infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Infectious; Infections; Communicable Diseases; Osteomyelitis
• Other Study ID Numbers: CPP Infection Registry