Clinical Trial: CPP Bone Infection Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:

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 Stat
    Sponsor: AO Clinical Investigation and Documentation
    

    Current Primary Outcome: Details on occurence and treatment of bone infection [ Time Frame: 1 December 2012 ]
    
    

    Original Primary Outcome:
    
    

    Current Secondary Outcome:

    • 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 ]
    
    
    

    Original Secondary Outcome:
    
    Information By: AO Clinical Investigation and Documentation
    

    Dates:
    Date Received: August 29, 2012
    Date Started: June 2012
    Date Completion: June 2018
    Last Updated: January 24, 2017
    Last Verified: January 2017