European Implant Cohort Study (EICS)
Recruitment status was: Not yet recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||European Implant Cohort Study|
- 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.
- 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.
|Study Start Date:||January 2013|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633619
|Centre Hospitalier Universitaire Vaudois (CHUV)|
|Lausanne, Vaud, Switzerland, 1011|
|Principal Investigator:||Andrej Trampuz, MD||Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne|
|Principal Investigator:||Olivier Borens, MD||Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne|