European Implant Cohort Study (EICS)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease
Bone Diseases

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Study Design

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Study Type :	Observational
Estimated Enrollment :	4000 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	European Implant Cohort Study
Study Start Date :	January 2013
Estimated Primary Completion Date :	January 2015

Groups and Cohorts

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Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Infection Outcome [ Time Frame: 2 years ]
   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 :

1. 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): ]
   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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Publications:

Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. Review.

Trampuz A, Hanssen AD, Osmon DR, Mandrekar J, Steckelberg JM, Patel R. Synovial fluid leukocyte count and differential for the diagnosis of prosthetic knee infection. Am J Med. 2004 Oct 15;117(8):556-62.

Schinsky MF, Della Valle CJ, Sporer SM, Paprosky WG. Perioperative testing for joint infection in patients undergoing revision total hip arthroplasty. J Bone Joint Surg Am. 2008 Sep;90(9):1869-75. doi: 10.2106/JBJS.G.01255. Erratum in: J Bone Joint Surg Am. 2010 Mar;92(3):707.

Atkins BL, Athanasou N, Deeks JJ, Crook DW, Simpson H, Peto TE, McLardy-Smith P, Berendt AR. Prospective evaluation of criteria for microbiological diagnosis of prosthetic-joint infection at revision arthroplasty. The OSIRIS Collaborative Study Group. J Clin Microbiol. 1998 Oct;36(10):2932-9.

Trampuz A, Piper KE, Jacobson MJ, Hanssen AD, Unni KK, Osmon DR, Mandrekar JN, Cockerill FR, Steckelberg JM, Greenleaf JF, Patel R. Sonication of removed hip and knee prostheses for diagnosis of infection. N Engl J Med. 2007 Aug 16;357(7):654-63.

Kurtz SM, Ong KL, Schmier J, Mowat F, Saleh K, Dybvik E, Kärrholm J, Garellick G, Havelin LI, Furnes O, Malchau H, Lau E. Future clinical and economic impact of revision total hip and knee arthroplasty. J Bone Joint Surg Am. 2007 Oct;89 Suppl 3:144-51.

Responsible Party:	Andrej Trampuz, Medical Doctor, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:	NCT01633619 History of Changes
Other Study ID Numbers:	CHUV0005
First Posted:	July 4, 2012
Last Update Posted:	July 4, 2012
Last Verified:	July 2012

Keywords provided by Andrej Trampuz, Centre Hospitalier Universitaire Vaudois:

Prosthetic Joint Infection

Additional relevant MeSH terms:

Bone Diseases; Musculoskeletal Diseases