NCT07473089

Swiss Revision Cohort

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 329 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Joint (Knee or Hip Replacement)
• Infection as Complication of Medical Care

Interventions

Type	Name	Description
PROCEDURE	Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle	Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection. A patient may contribute one or more episodes, which are defined as a condition leading to revision surgery for a suspected or confirmed periprosthetic joint infection.

Timeline

• Start date: 2022-09-23
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

5 sites across 1 country: Switzerland