CPP Bone Infection Registry (CPP Infection)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01677000
First received: August 29, 2012
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

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.

Condition
Bone Infection
Staphylococcus Aureus

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Clinical Priority Program: Bone Infection; Use of a Registry on Infection to Improve Patient Outcomes and Research Efforts

Resource links provided by NLM:


Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • Details on occurence and treatment of bone infection [ Time Frame: 1 December 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical approach, implants and technology [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]
  • Patient outcome [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]
  • Post-procedure complications and revisions [ Time Frame: 01 December 2012 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples nasal and wound specimen


Estimated Enrollment: 400
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with diagnosis of Staphylococcus aureus bone infection

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01677000

Contacts
Contact: Patrick Hiltpold +41 44 200 24 66 patrick.hiltpold@aofoundation.org
Contact: Stephen L Kates, MD +1 585 34 10 485 stephen_kates@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Stephen L Kates, MD    585-341-0485    stephen_kates@urmc.rochester.edu   
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Steven L Kates, MD University of Rochester
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01677000     History of Changes
Other Study ID Numbers: CPP Infection Registry
Study First Received: August 29, 2012
Last Updated: August 13, 2014
Health Authority: United States: Institutional Review Board
Argentina: Ethics Committee
Austria: Ethikkommission
Canada: Ethics Review Committee
China: Ethics Committee
Denmark: Ethics Committee
Germany: Ethics Commission
Japan: Institutional Review Board
Switzerland: Ethikkommission

Keywords provided by AO Clinical Investigation and Documentation:
bone infection
staphylococcus aureus
registry

Additional relevant MeSH terms:
Infection
Communicable Diseases
Osteomyelitis
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 16, 2014