Clinical Priority Program-Bone Infection Registry

NCT ID: NCT01677000

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 297 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Bone Infection; Staphylococcus Aureus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen L Kates, MD

Role: PRINCIPAL_INVESTIGATOR

University of Richmond

Locations

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

Countries

United States; Argentina; Austria; Belgium; Canada; China; Denmark; Germany; Japan; Switzerland

Other Identifiers

CPP Infection Registry

Identifier Type: -

Identifier Source: org_study_id