Joint (Knee or Hip Replacement)REVCONCT07473089
Swiss Revision Cohort
An observational study of Joint (Knee or Hip Replacement) and Infection as Complication of Medical Care, run by Insel Gruppe AG, University Hospital Bern at 5 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint (Knee or Hip Replacement), Infection as Complication of Medical Care
- What is being tested?
- Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle
- Type of treatment
- Surgery or procedure
- How many people
- 329 participants
- Where
- 5 sitesSwitzerland
- Study dates
- 23 Sep 2022to Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection.
Who may be able to join
- ≥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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Switzerland5 sites, 5 recruiting
- Recruiting
Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau
Aarau
Anna Conen, +41628386812, Anna.Conen@ksa.ch
- Recruiting
Department of Infectious Diseases, Bern University Hospital
Bern
Christine Thurnheer Zürcher, +41 31 632 21 11, Christine.Thurnheer@insel.ch
- Recruiting
Department of Medicine, HFR Fribourg-Hôpital Cantonal
Fribourg
Antonios Kritikos, +41263062470, Antonios.Kritikos@h-fr.ch
- Recruiting
Orthopedic Surgery Service, Geneva University Hospitals
Geneva
Truong-Thanh Pham, +41223723311, truong-thanh.pham@hug.ch
- Recruiting
Department of Medicine, Lausanne University Hospital
Lausanne
Sylvain Steinmetz, +41213149403, Sylvain.Steinmetz@chuv.ch
About this study
Official title: 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.
Read the 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.
- Being tested
- Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle
- Keywords
- total joint arthroplasty, periprosthetic joint infection, antimicrobial therapy, infection, functional outcomes, patient-reported outcome measures
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankleProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
Mean of range of motion measurement (hip)
Range of motion measurements validated in orthopaedic and traumatology practice for those with a hip replacement.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start23 Sep 2022
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Joint (Knee or Hip Replacement)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 329 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nora Renz, Principal investigator, Inselspital, Universitätsspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473089
- Sponsor's protocol ID
- 2021-01791
- Acronym
- REVCO
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Interested researchers can access all available data if a study proposal is approved by the Swiss Revision Cohort scientific board.
Publications
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.
PubMed 34060985Karczewski 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.
PubMed 30700114Osmon 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.
PubMed 23230301Koh 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.
PubMed 28573549Pallanza M, Ateschrang A, Boyd A, Conen A, Kritikos A, Laurencon J, Liechti EF, Meylan S, Pham TT, Steinmetz S, Suva D, Thurnheer MC, Renz N. Nationwide, multicentre, prospective periprosthetic joint infection cohort study: study protocol of the Swiss Revision Cohort (REVCO). BMJ Open. 2026 Jul 16;16(7):e120092. doi: 10.1136/bmjopen-2026-120092.
PubMed 42463213
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swiss Revision Cohort: a Nationwide, Multi-center, Prospective Periprosthetic Joint Infection Cohort Study
- ClinicalTrials.gov ID
- NCT07473089
- Acronym / sponsor ID
- REVCO / 2021-01791
- Keywords
- total joint arthroplasty, periprosthetic joint infection, antimicrobial therapy, infection, functional outcomes, patient-reported outcome measures
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 329 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who undergo revision surgery of a prosthetic hip, knee, shoulder, ankle, or elbow joint for suspected periprosthetic joint infection.
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankleParticipants 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. | Procedure or surgery | – |
Primary outcome
Rate of infection failure
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.
8 secondary outcomes
Mean of range of motion measurement (hip)
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 range of motion measurement (knee)
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
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 walking aids (for lower extremity)
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 EuroQol five-dimensional questionnaire score
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
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 adverse events from antibiotic treatment
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 34060985Vuorinen 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.
- Background: PubMed 30700114Karczewski 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.
- Background: PubMed 23230301Osmon 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.
- Background: PubMed 28573549Koh 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.
- Derived from this study: PubMed 42463213Pallanza M, Ateschrang A, Boyd A, Conen A, Kritikos A, Laurencon J, Liechti EF, Meylan S, Pham TT, Steinmetz S, Suva D, Thurnheer MC, Renz N. Nationwide, multicentre, prospective periprosthetic joint infection cohort study: study protocol of the Swiss Revision Cohort (REVCO). BMJ Open. 2026 Jul 16;16(7):e120092. doi: 10.1136/bmjopen-2026-120092.
- Individual participant dataSharing planned: Yes. Interested researchers can access all available data if a study proposal is approved by the Swiss Revision Cohort scientific board.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nora Renz principal investigator
Inselspital, Universitätsspital Bern
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint (Knee or Hip Replacement) and Infection as Complication of Medical Care, run by Insel Gruppe AG, University Hospital Bern at 5 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nora Renz (+41316322111, nora.renz@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of infection failure (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07473089, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.