Swiss Revision Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥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
Disqualifiers
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
Trial population
Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle
Procedure/SurgeryParticipants 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
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.Secondary outcomes
1
Mean of range of motion measurement (hip)
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.2
Mean of range of motion measurement (knee)
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.3
Percent using any analgesics
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.4
Percent using walking aids (for lower extremity)
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.Sponsors and contacts
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Source ClinicalTrials.gov