Study protocol : The daicy trial—dual versus single-antibiotic impregnated cement in primary hemiarthroplasty for femoral neck fracture—a register-based cluster-randomized crossover-controlled trial
(2022) In Acta Orthopaedica 93. p.794-800- Abstract
Background and purpose — Older patients with a displaced femoral neck fracture (FNF) are often treated with a cemented primary hemiarthroplasty (HA). The DAICY trial investigates whether high-dose dual-impregnated antibiotic-loaded cement (DIAC) including gentamicin and clindamycin can reduce the risk of periprosthetic joint infection (PJI) in comparison with low-dose single-impregnated gentamicin antibiotic-loaded cement (SIAC), in patients ≥ 60 years treated with a cemented HA for a displaced FNF. Study design — The trial is a national, multicenter, register-based, cluster-randomized, crossover trial. Patients ≥ 60 years with a non-pathological, displaced FNF (Type Garden 3–4/AO 31-B2 or B3) suitable for HA according to local... (More)
Background and purpose — Older patients with a displaced femoral neck fracture (FNF) are often treated with a cemented primary hemiarthroplasty (HA). The DAICY trial investigates whether high-dose dual-impregnated antibiotic-loaded cement (DIAC) including gentamicin and clindamycin can reduce the risk of periprosthetic joint infection (PJI) in comparison with low-dose single-impregnated gentamicin antibiotic-loaded cement (SIAC), in patients ≥ 60 years treated with a cemented HA for a displaced FNF. Study design — The trial is a national, multicenter, register-based, cluster-randomized, crossover trial. Patients ≥ 60 years with a non-pathological, displaced FNF (Type Garden 3–4/AO 31-B2 or B3) suitable for HA according to local guidelines are eligible for inclusion. Participating orthopedic departments will be randomized to start with either SIAC (control group) or DIAC treatment (intervention group) for 2 years. After 2 years, the study departments will then change to the other treatment arm for the remaining 2 years of the study. Approximately 7,000 patients will be included. The study is pragmatic in that the choice of implant brands, surgical approach and peri- and postoperative protocols follow the local routines of each participating department. All outcome variables will be retrieved after linkage of the study cohort to the following Swedish registers: the Fracture Register, the Arthroplasty Register, the National Patient Register and the Prescribed Drug Registry Outcome — The primary outcome will be periprosthetic joint infection of the index joint within 1 year after surgery. Secondary outcomes will be any reoperation on the index joint, mortality within 90 days and 1 year, resistance patterns of causative bacteria in cases of PJI, and health economics. Potential added value — This trial is designed to support or refute the efficacy of DIAC used in patients with a displaced FNF, potentially reducing PJI and resource allocation. Start of the trial and estimated duration — The DAICY trial started recruiting patients in January 2022 and will continue recruiting for approximately 4 years. Complete follow-up expected in 5 years.
(Less)
- author
- Mukka, Sebastian ; Hailer, Nils P. ; Möller, Michael LU ; Gordon, Max ; Lazarinis, Stergios ; Rogmark, Cecilia LU ; Östlund, Ollie ; Sköldenberg, Olof and Wolf, Olof
- author collaboration
- organization
- publishing date
- 2022
- type
- Contribution to journal
- publication status
- published
- subject
- in
- Acta Orthopaedica
- volume
- 93
- pages
- 7 pages
- publisher
- Taylor & Francis
- external identifiers
-
- pmid:36200646
- scopus:85139280843
- ISSN
- 1745-3674
- DOI
- 10.2340/17453674.2022.4819
- language
- English
- LU publication?
- yes
- id
- 691d00d3-5764-4f07-a743-18d8a925225f
- date added to LUP
- 2022-12-14 15:13:17
- date last changed
- 2024-04-14 10:36:35
@article{691d00d3-5764-4f07-a743-18d8a925225f,
abstract = {{<p>Background and purpose — Older patients with a displaced femoral neck fracture (FNF) are often treated with a cemented primary hemiarthroplasty (HA). The DAICY trial investigates whether high-dose dual-impregnated antibiotic-loaded cement (DIAC) including gentamicin and clindamycin can reduce the risk of periprosthetic joint infection (PJI) in comparison with low-dose single-impregnated gentamicin antibiotic-loaded cement (SIAC), in patients ≥ 60 years treated with a cemented HA for a displaced FNF. Study design — The trial is a national, multicenter, register-based, cluster-randomized, crossover trial. Patients ≥ 60 years with a non-pathological, displaced FNF (Type Garden 3–4/AO 31-B2 or B3) suitable for HA according to local guidelines are eligible for inclusion. Participating orthopedic departments will be randomized to start with either SIAC (control group) or DIAC treatment (intervention group) for 2 years. After 2 years, the study departments will then change to the other treatment arm for the remaining 2 years of the study. Approximately 7,000 patients will be included. The study is pragmatic in that the choice of implant brands, surgical approach and peri- and postoperative protocols follow the local routines of each participating department. All outcome variables will be retrieved after linkage of the study cohort to the following Swedish registers: the Fracture Register, the Arthroplasty Register, the National Patient Register and the Prescribed Drug Registry Outcome — The primary outcome will be periprosthetic joint infection of the index joint within 1 year after surgery. Secondary outcomes will be any reoperation on the index joint, mortality within 90 days and 1 year, resistance patterns of causative bacteria in cases of PJI, and health economics. Potential added value — This trial is designed to support or refute the efficacy of DIAC used in patients with a displaced FNF, potentially reducing PJI and resource allocation. Start of the trial and estimated duration — The DAICY trial started recruiting patients in January 2022 and will continue recruiting for approximately 4 years. Complete follow-up expected in 5 years.</p>}},
author = {{Mukka, Sebastian and Hailer, Nils P. and Möller, Michael and Gordon, Max and Lazarinis, Stergios and Rogmark, Cecilia and Östlund, Ollie and Sköldenberg, Olof and Wolf, Olof}},
issn = {{1745-3674}},
language = {{eng}},
pages = {{794--800}},
publisher = {{Taylor & Francis}},
series = {{Acta Orthopaedica}},
title = {{Study protocol : The daicy trial—dual versus single-antibiotic impregnated cement in primary hemiarthroplasty for femoral neck fracture—a register-based cluster-randomized crossover-controlled trial}},
url = {{http://dx.doi.org/10.2340/17453674.2022.4819}},
doi = {{10.2340/17453674.2022.4819}},
volume = {{93}},
year = {{2022}},
}