CPP Bone Infection Registry (CPP Infection)

This study is currently recruiting participants.
Verified October 2013 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: October 7, 2013
Last verified: October 2013
  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 and older
  • confirmed Staphylococcus aureus (MRSA or OSSA) bone and/or prosthetic joint infection
  • patients without implants but with confirmed osteomyelitis
  • ability to understand the content of the patient information/informed consent form and to participate in the clinical investigation
  • signed informed consent

Exclusion Criteria:

  • patients with infections other than MRSA or OSSA
  • patients who cannot give informed consent or assent from a family member
  • patients who cannot attend the follow-up visits or cannot answer the questions
  • prisoners
  Contacts and Locations
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: October 7, 2013
Health Authority: United States: Institutional Review Board
Austria: Ethikkommission
Brazil: Ethics Committee
Canada: Ethics Review Committee
China: Ethics Committee
Denmark: Ethics Committee
Egypt: Institutional Review Board
Germany: Ethics Commission
Japan: Institutional Review Board
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Osteomyelitis
Staphylococcal Infections
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 16, 2014