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The investigators tested the working hypothesis if 4 weeks of systemic antibiotic treatment in implant-related orthopaedic infections is non-inferior to 6 weeks after complete removal of the infected implant. Randomization 1:1.
The study is completed. It halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Former description of the study (now completed)
Osteoarticular infections related to orthopaedic implants are associated with substantial morbidity, prolongation of hospital stay, and additional costs. Due to the increasing number of patients with orthopaedic implants in Switzerland, similar to the rest of Europe and elsewhere, the number of infections is expected to increase. While the surgical treatment of these infections has been well studied, the ideal duration of antibiotic therapy after removal (explantation) of the infected implant remains unknown. For almost 40 years, the recommended total duration of post-explantation antibiotic therapy has been 6 weeks. This recommendation is based on expert's personal experience rather than on prospective randomized studies. Shorter treatment would decrease antibiotic-related adverse events and costs hospital stay for patients awaiting an eventual reinsertion of a new implant. If physicians and surgeon prescribe antibiotics for 6 weeks, this duration should be at least supported by evidence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 weeks of treatment | Experimental |
| |
| 6 weeks of treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Removal of infected implant | Procedure |
| ||
| Antibiotic durations |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of infection | Clinical evaluation | 12 months |
| Adverse events | Clinical adverse events | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilker Uçkay, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Geneva | 1211 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24052163 | Background | Al-Mayahi M, Betz M, Muller DA, Stern R, Tahintzi P, Bernard L, Hoffmeyer P, Suva D, Uckay I. Remission rate of implant-related infections following revision surgery after fractures. Int Orthop. 2013 Nov;37(11):2253-8. doi: 10.1007/s00264-013-2092-1. Epub 2013 Sep 20. |
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