drugset / Trial / NCT05164081
Dual vs. Single-Antibiotic Impregnated Cement in Hemiarthroplasty for Femoral Neck Fracture
RandomizedCrossoverOpen-labelPrevention
Summary
Rational for conducting the study: Periprosthetic joint infection (PJI) is the most feared complication following prosthetic replacement of the hip joint and is associated with increased mortality, morbidity and economic burden. The aim of the trial is to investigate whether the risk of periprosthetic joint infection after treatment with hemiarthroplasty performed due to femoral neck fracture is reduced after the use of dual-impregnated antibiotic loaded cement. The primary outcome variable is the incidence of periprosthetic joint infection within one year after the index procedure. Secondary outcome variables include the occurrence of re-operations for any reason, bacteriology, antibiotic treatment, mortality and health care costs.
Timeline
- Start
- 2022-01-01
- Primary completion
- 2026-01-31
- Completion
- 2027-01-31
Publications
- Background Sprowson AP, Jensen C, Chambers S, Parsons NR, Aradhyula NM, Carluke I, Inman D, Reed MR. The use of high-dose dual-impregnated antibiotic-laden cement with hemiarthroplasty for the treatment of a fracture of the hip: The Fractured Hip Infection trial. Bone Joint J. 2016 Nov;98-B(11):1534-1541. doi: 10.1302/0301-620X.98B11.34693.
- Background Agni NR, Costa ML, Achten J, O'Connor H, Png ME, Peckham N, Dutton SJ, Wallis S, Milca S, Reed M. A randomized clinical trial of low dose single antibiotic-loaded cement versus high dose dual antibiotic-loaded cement in patients receiving a hip hemiarthroplasty after fracture: A protocol for the WHiTE 8 COPAL study. Bone Jt Open. 2021 Feb;2(2):72-78. doi: 10.1302/2633-1462.22.BJO-2020-0174.
- Background Mukka S, Hailer NP, Moller M, Gordon M, Lazarinis S, Rogmark C, Ostlund O, Skoldenberg O, Wolf O; DAICY study group. 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. Acta Orthop. 2022 Oct 5;93:794-800. doi: 10.2340/17453674.2022.4819.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clindamycin | Unknown | — | — |
| Background | Gentamicin | Small molecule | — | — |