Swiss Revision Cohort

NCT07473089 | Recruiting

• 1 other identifier: 2021-01791
• Study Type: observational
• Target: 329
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

total joint arthroplasty; periprosthetic joint infection; antimicrobial therapy; infection; functional outcomes; patient-reported outcome measures

Outcome Measures

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.

  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)

  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)

  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

  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)

  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

  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.

Interventions

Revision for periprosthetic joint infections of the hip, knee, shoulder, elbow or ankle PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (5)

Department of Infectious Diseases and Infection Prevention, Cantonal Hospital Aarau

Aarau, Switzerland

RECRUITING

Department of Infectious Diseases, Bern University Hospital

Bern, Switzerland

RECRUITING

Department of Medicine, HFR Fribourg-Hôpital Cantonal

Fribourg, Switzerland

RECRUITING

Orthopedic Surgery Service, Geneva University Hospitals

Geneva, Switzerland

RECRUITING

Department of Medicine, Lausanne University Hospital

Lausanne, Switzerland

RECRUITING

Related Publications (4)

• 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.

  PMID: 34060985 BACKGROUND

• 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.

  PMID: 30700114 BACKGROUND

• 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.

  PMID: 23230301 BACKGROUND

• 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.

  PMID: 28573549 BACKGROUND

MeSH Terms

Conditions

Infections

Interventions

Second-Look Surgery

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Nora Renz

  Inselspital, Universitätsspital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nora Renz

CONTACT

+41316322111; nora.renz@insel.ch

Christine Thurnheer

CONTACT

+41316327732; Christine.Thurnheer@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 16, 2026
• Study Start: September 23, 2022
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
• Time Frame: Unending

Locations

CH (5)