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CPP Bone Infection Registry (CPP Infection)

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ClinicalTrials.gov Identifier: NCT01677000
Recruitment Status : Active, not recruiting
First Posted : August 31, 2012
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

August 29, 2012
August 31, 2012
July 6, 2018
June 2012
October 2018   (Final data collection date for primary outcome measure)
Details on occurence and treatment of bone infection [ Time Frame: 1 December 2012 ]
Not Provided
Complete list of historical versions of study NCT01677000 on ClinicalTrials.gov Archive Site
  • Surgical approach, implants and technology [ Time Frame: 01 December 2012 ]
  • Patient outcome [ Time Frame: 01 December 2012 ]
  • Post-procedure complications and revisions [ Time Frame: 01 December 2012 ]
Not Provided
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CPP Bone Infection Registry
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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
blood samples nasal and wound specimen
Non-Probability Sample
patients with diagnosis of Staphylococcus aureus bone infection
  • Bone Infection
  • Staphylococcus Aureus
Not Provided
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
400
June 2019
October 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Canada,   China,   Denmark,   Germany,   Japan,   Switzerland,   United States
 
 
NCT01677000
CPP Infection Registry
Yes
Not Provided
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AO Clinical Investigation and Documentation
AO Clinical Investigation and Documentation
Not Provided
Principal Investigator: Stephen L Kates, MD University of Richmond
AO Clinical Investigation and Documentation
July 2018