Swiss Revision Cohort (REVCO)

Swiss Revision Cohort: a Nationwide, Multi-center, Prospective Periprosthetic Joint Infection Cohort Study

This study follows patients with infections after a joint replacement over time. During follow-up, treatment outcomes are carefully measured to determine whether the infection can be cured. In addition, factors that may change infection cure rates are examined, including the patient's overall health, the type of bacteria causing the infection, and the surgical and antibiotic treatments used. The goal is to understand what leads to more frequent cure and to improve future care.

Study Overview

• Status: Recruiting
• Conditions: Infection as Complication of Medical Care; Joint (Knee or Hip Replacement)
• Intervention / Treatment: Procedure: Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle

Detailed Description

Diagnostic and therapeutic management of patients with periprosthetic joint infections (PJIs) remains challenging. Successful management of PJI requires revision surgery of the prosthetic joint. The Swiss National Joint Registry (SIRIS) reported two-year revision rates of 2.5% for total hip arthroplasty and 3.3% for total knee arthroplasty in 2023, with infection being the most frequent cause of early revision (27.9% for hips and 20.6% for knees). Despite published guidelines, the management of PJI remains insufficiently standardized, primarily due to heterogeneous clinical presentations and limited availability of rigorous data from prospective studies and randomized controlled trials comparing interventions to improve outcomes. The presence of foreign material with biofilm formation further complicates the diagnosis and treatment of PJI, posing a significant challenge for clinicians necessitating close collaboration among specialists from various medical fields, including orthopaedic surgeons, microbiologists and infectious disease experts. A recent observational study suggests that a multidisciplinary team approach is associated with improved diagnostics, fewer surgeries, reduced length of hospital stay, and higher success rates.

This national cohort aims to describe the epidemiology, clinical phenotypes, management strategies and outcomes of patients with PJI. This is a national, multicentre, prospective, longitudinal, observational cohort study of patients who underwent revision for PJI of the hip, knee, shoulder, elbow or ankle. Participating centres include university or non-university tertiary healthcare facilities located in Switzerland. Episodes include likely and confirmed PJI, as defined by the European Bone and Joint Infection Society (EBJIS) criteria. During routine clinical visits after revision surgery, data are collected and patients are followed-up thereafter for a minimum of two years. The primary objective is infection outcome and secondary objectives include functional outcome and patient satisfaction, and evaluation of host, infection, microbiological and treatment factors associated with treatment failure and poor functional outcomes, both in the overall population and across subgroups. A minimum of 329 patients would be needed to have sufficient statistical power to carry out these analyses.

• Study Type: Observational
• Enrollment (Estimated): 329

Contacts and Locations

• Study Contact: Name: Nora Renz; Phone Number: +41316322111; Email: nora.renz@insel.ch
• Study Contact Backup: Name: Christine Thurnheer; Phone Number: +41316327732; Email: Christine.Thurnheer@insel.ch

Study Locations

• Switzerland
  • Aarau, Switzerland
    • Recruiting
    • Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau
    • Contact: Anna Conen; Phone Number: +41628386812; Email: Anna.Conen@ksa.ch
  • Bern, Switzerland
    • Recruiting
    • Department of Infectious Diseases, Bern University Hospital
    • Contact: Christine Thurnheer Zürcher; Phone Number: +41 31 632 21 11; Email: Christine.Thurnheer@insel.ch
  • Fribourg, Switzerland
    • Recruiting
    • Department of Medicine, HFR Fribourg-Hôpital Cantonal
    • Contact: Antonios Kritikos; Phone Number: +41263062470; Email: Antonios.Kritikos@h-fr.ch
  • Geneva, Switzerland
    • Recruiting
    • Orthopedic Surgery Service, Geneva University Hospitals
    • Contact: Truong-Thanh Pham; Phone Number: +41223723311; Email: truong-thanh.pham@hug.ch
  • Lausanne, Switzerland
    • Recruiting
    • Department of Medicine, Lausanne University Hospital
    • Contact: Sylvain Steinmetz; Phone Number: +41213149403; Email: Sylvain.Steinmetz@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection.

Description

Inclusion Criteria:

• ≥18 years of age
• Revision surgery of any large prosthetic joint (i.e., hip, knee, shoulder, ankle, or elbow) performed for a suspected or confirmed periprosthetic joint infections at any of the participating study centres. This includes patients who were previously treated at another hospital and referred to a participating study centre if data on a transferred patient from the previous institution are available, complete, and archived in the institutional patient information system, and the patient underwent at least one surgery at a participating institution.
• Obtained written informed consent
• Periprosthetic joint infections diagnosis likely or confirmed according to European Bone and Joint Infection Society criteria

Exclusion Criteria:

• Documented objection to subsequent use of personal health data
• Patient follow-up outside of Switzerland
• Diagnosis "periprosthetic joint infections unlikely" according to European Bone and Joint Infection Society criteria

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of infection failure	Rate of incident periprosthetic joint infection (according to European Bone & Joint Infection Society criteria) or infection-related death. Types of failure include i) persistent or recurrent PJI with the same pathogen or no detected pathogen (i.e., treatment failure) and ii) a new infection caused by a pathogen different from the index episode.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean of range of motion measurement (hip)	Range of motion measurements validated in orthopaedic and traumatology practice for those with a hip replacement.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Mean of range of motion measurement (knee)	Range of motion measurements validated in orthopaedic and traumatology practice for those with a knee replacement.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Percent using any analgesics	Percent using any analgesics drugs to relieve pain.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Percent using walking aids (for lower extremity)	Percent using a walking aid for those who had joint replacements of the lower extremities.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Mean of EuroQol five-dimensional questionnaire score	Mean of the EuroQol five-dimensional questionnaire (EQ-5D-5L) score, including patient mobility/independency in daily life and quality of life. Range of scores 0 (dead) and 1 (full health).	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Mean of subjective evaluation of pain	Mean of subjective evaluation of pain using a visual pain scale (1-10 points). Higher scores indicate worse pain.	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Percent of adverse events from antibiotic treatment	Percent of overall adverse events associated with antimicrobial treatment (including the need for treatment modification).	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.
Percent requiring surgical intervention	Percent requiring surgical intervention (including the need for additional revision).	Up to 5 years. The outcome will be evaluated during the period from enrollment until the date of last clinical visit, adminstrative censoring, lost to follow-up, death; whichever occurs first.

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Nora Renz, Inselspital, Universitätsspital Bern

Publications and helpful links

General Publications

• Osmon DR, Berbari EF, Berendt AR, Lew D, Zimmerli W, Steckelberg JM, Rao N, Hanssen A, Wilson WR; Infectious Diseases Society of America. Executive summary: diagnosis and management of prosthetic joint infection: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis. 2013 Jan;56(1):1-10. doi: 10.1093/cid/cis966.
• Koh CK, Zeng I, Ravi S, Zhu M, Vince KG, Young SW. Periprosthetic Joint Infection Is the Main Cause of Failure for Modern Knee Arthroplasty: An Analysis of 11,134 Knees. Clin Orthop Relat Res. 2017 Sep;475(9):2194-2201. doi: 10.1007/s11999-017-5396-4. Epub 2017 Jun 1.
• Vuorinen M, Makinen T, Rantasalo M, Huotari K. Effect of a multidisciplinary team on the treatment of hip and knee prosthetic joint infections: a single-centre study of 154 infections. Infect Dis (Lond). 2021 Sep;53(9):700-706. doi: 10.1080/23744235.2021.1925341. Epub 2021 Jun 1.
• Karczewski D, Winkler T, Renz N, Trampuz A, Lieb E, Perka C, Muller M. A standardized interdisciplinary algorithm for the treatment of prosthetic joint infections. Bone Joint J. 2019 Feb;101-B(2):132-139. doi: 10.1302/0301-620X.101B2.BJJ-2018-1056.R1.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: infection; periprosthetic joint infection; total joint arthroplasty; functional outcomes; antimicrobial therapy; patient-reported outcome measures
• Additional Relevant MeSH Terms: Infections; Surgical Procedures, Operative; Second-Look Surgery
• Other Study ID Numbers: 2021-01791

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Interested researchers can access all available data if a study proposal is approved by the Swiss Revision Cohort scientific board.
• IPD Sharing Time Frame: Unending
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No