European Implant Cohort Study

NCT01633619 | Unknown DMC

• 1 other identifier: CHUV0005
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Diseases

Keywords

Prosthetic Joint Infection

Outcome Measures

Primary Outcomes (1)

• Infection Outcome

  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.

  2 years

Secondary Outcomes (1)

• Functional outcome

  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):

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Subject is older than 18 years of age.
• Written Informed consent has been obtained.
• 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,
• Subject is willing to participate in the study, to follow protocol study treatment regimen, and to comply with all planned follow-up assessments.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (6)

• Zimmerli W, Trampuz A, Ochsner PE. Prosthetic-joint infections. N Engl J Med. 2004 Oct 14;351(16):1645-54. doi: 10.1056/NEJMra040181. No abstract available.

  PMID: 15483283 BACKGROUND

• 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. doi: 10.1016/j.amjmed.2004.06.022.

  PMID: 15465503 BACKGROUND

• 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.

  PMID: 18762646 BACKGROUND

• 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. doi: 10.1128/JCM.36.10.2932-2939.1998.

  PMID: 9738046 BACKGROUND

• 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. doi: 10.1056/NEJMoa061588.

  PMID: 17699815 BACKGROUND

• Kurtz SM, Ong KL, Schmier J, Mowat F, Saleh K, Dybvik E, Karrholm 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. doi: 10.2106/JBJS.G.00587. No abstract available.

  PMID: 17908880 BACKGROUND

MeSH Terms

Conditions

Bone Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Andrej Trampuz, MD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

  PRINCIPAL INVESTIGATOR

• Olivier Borens, MD

  Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrej Trampuz, MD

CONTACT

0041 213143992; Andrej.Trampuz@chuv.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 4, 2012
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Last Updated: July 4, 2012

Record last verified: 2012-07

Locations

CH (1)