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

Sebastian Mukka; Nils P Hailer; Michael Möller; Max Gordon; Stergios Lazarinis; Cecilia Rogmark; Ollie Östlund; Olof Sköldenberg; Olof Wolf; The DAICY study group

doi:10.2340/17453674.2022.4819

Authors

Sebastian Mukka Department of Surgical and Perioperative Science (Orthopaedics), Umeå University, Umeå https://orcid.org/0000-0002-5469-2730
Nils P Hailer Department of Surgical Sciences, Orthopaedics, Uppsala University, Uppsala https://orcid.org/0000-0002-3233-2638
Michael Möller Institute of Clinical Science, Sahlgrenska Academy, University of Gothenburg, Gothenburg; Swedish Fracture Register, Registercentrum Västra Götaland, Gothenburg https://orcid.org/0000-0001-7394-6057
Max Gordon Department of Clinical Sciences at Danderyd Hospital, Division of Orthopaedics, Karolinska Institutet, Stockholm https://orcid.org/0000-0002-8080-5815
Stergios Lazarinis Department of Surgical Sciences, Orthopaedics, Uppsala University, Uppsala
Cecilia Rogmark Department of Orthopedics, Lund University, Skåne University Hospital, Malmö; Swedish Arthroplasty Register, Registercentrum Västra Götaland, Gothenburg https://orcid.org/0000-0002-6556-4320
Ollie Östlund Uppsala Clinical Research Center, Uppsala, Sweden https://orcid.org/0000-0001-8028-2308
Olof Sköldenberg Department of Clinical Sciences at Danderyd Hospital, Division of Orthopaedics, Karolinska Institutet, Stockholm
Olof Wolf Department of Surgical Sciences, Orthopaedics, Uppsala University, Uppsala; Swedish Fracture Register, Registercentrum Västra Götaland, Gothenburg https://orcid.org/0000-0001-6668-8715
The DAICY study group

DOI:

https://doi.org/10.2340/17453674.2022.4819

Keywords:

Arthroplasty, Bone cement, Femoral neck fracture, Fractures, Hip, Infection, RCT

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 antibioticloaded 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.