European Implant Cohort Study (EICS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2012 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Information provided by (Responsible Party):
Andrej Trampuz, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT01633619
First received: July 2, 2012
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

The incidence of postoperative PJI is ranging from 0.5-2.5% for primary interventions and are reported up to 20% for revision procedure. In addition, hematogenous PJI can occur at any time after implantation and the risk of infection remains during the entire prosthesis indwelling time. Prosthetic joint infections (PJI) are associated with significant morbidity and costs to the healthcare system. Evidence for optimal management of PJI with best outcome and lowest expenses is limited and recommendations between countries vary significantly. There is unmet need to standardized diagnostic procedures and definition of infection as well as achieve a consensus for uniform treatment guidelines.The European Implant Cohort Study (EICS) is a multicenter European research project, including patients with PJI in a cohort representative for Europe. The EICS is established jointly by the Orthopedic and Traumatology surgeons, Infectious Diseases specialists and microbiologists of selected university and non-university institutions across Europe. The principal aim of the EICS is to improve the management of PJI and develop consensus guidelines across Europe. By systematic analysis of consecutively included patients with PJI, factors associated with best outcome regarding infection (assessed by the infection-free interval) and joint function (assessed by the degree of pain, mobility, range of motion) will be determined in a longitudinal prospective study with long-term follow-up. This is an investigator-initiated, open, prospective, multicenter observational study. Participating study centers will be university or non-university hospitals across Europe, which fulfill the following study conditions:

  • Close collaboration between infectious diseases specialists, microbiologists and orthopedic/trauma surgeons,
  • Availability of appropriate microbiological methods (following standard recommendations including sonication of removed prosthesis),
  • Availability a dedicated study team (study nurse and/or research fellow) for regular eligibility screenings, patient inclusion procedure, real-time data collection and patient follow-up.

This project may generate important scientific evidence for future guidelines regarding management of PJI, has the potential to initiate new multicenter substudies in an establish network, and may open further collaboration and exchange of skills between institutions across Europe.


Condition
Bone Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Implant Cohort Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Infection Outcome [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    This will be determined as the infection-free interval after end of treatment. Infection-free status is defined as absence of clinical (e.g. no fistula), laboratory (e.g. normal C-reactive protein) and radiological signs of infection (e.g. no septic loosening). The expected "cure rate", defined as the infection-free interval at 2 years, is >80%. The treatment outcome of the combined (antimicrobial and surgical) treatment approach will be assessed in a time-dependent manner using the Kaplan-Meier survival method.


Secondary Outcome Measures:
  • Functional outcome [ Time Frame: The following data will be collected at study inclusion, during hospitalization and during follow-up visits (3, 6, 12 months and thereafter as the usual clinical practice): ] [ Designated as safety issue: No ]
    The functional assessment will be performed using joint-specific scores involving the range of motion (ROM), patient mobility / independency in daily life and subjective evaluation of pain using a pain scale (1-10 points). The expected functional outcome is that >60% patients return to previous life activities, >75% reduction of pain.


Estimated Enrollment: 4000
Study Start Date: January 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

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

All patient with hip, knee and shoulder prosthetic joint infection.

Criteria

Inclusion Criteria:

  1. Subject is older than 18 years of age.
  2. Written Informed consent has been obtained.
  3. Subject has a prosthetic joint infection (PJI) of the hip, knee or shoulder prosthesis defined as presence of at least one of the following criteria:

    • visible pus around the prosthesis
    • presence of sinus tract (fistula),
    • acute inflammation in histopathology of periprosthetic tissue
    • positive microbiology of synovial fluid, sonication or periprosthetic tissue
    • increased leukocyte count or neutrophil percentage in preoperative synovial fluid aspirate,
  4. Subject is willing to participate in the study, to follow protocol study treatment regimen, and to comply with all planned follow-up assessments.

Exclusion Criteria:

  1. Subject has been previously enrolled in the study or is currently enrolled in another investigational study, which deviates from the treatment algorithm.
  2. Inability to read and understand the participant's information.
  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: NCT01633619

Contacts
Contact: Andrej Trampuz, MD 0041 213143992 Andrej.Trampuz@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois (CHUV) Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Andrej Trampuz, MD Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
Principal Investigator: Olivier Borens, MD Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne
  More Information

Additional Information:
Publications:
Responsible Party: Andrej Trampuz, Medical Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT01633619     History of Changes
Other Study ID Numbers: CHUV0005
Study First Received: July 2, 2012
Last Updated: July 3, 2012
Health Authority: European Union: European Medicines Agency

Keywords provided by Centre Hospitalier Universitaire Vaudois:
Prosthetic Joint Infection

Additional relevant MeSH terms:
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014