NCT Number: NCT07473089
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau, Aarau, Switzerland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
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.
Time frame: 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.
Range of motion measurements validated in orthopaedic and traumatology practice for those with a hip replacement.
Time frame: 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.
Range of motion measurements validated in orthopaedic and traumatology practice for those with a knee replacement.
Time frame: 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 drugs to relieve pain.
Time frame: 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 a walking aid for those who had joint replacements of the lower extremities.
Time frame: 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 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).
Time frame: 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 using a visual pain scale (1-10 points). Higher scores indicate worse pain.
Time frame: 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 overall adverse events associated with antimicrobial treatment (including the need for treatment modification).
Time frame: 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 (including the need for additional revision).
Contact information is provided by the study sponsor or research team.
Christine Thurnheer
CONTACT
Nora Renz
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
Swiss Revision Cohort: a Nationwide, Multi-center, Prospective Periprosthetic Joint Infection Cohort Study
Acronym: REVCO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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