Register-based randomized trials: the new power-tool in orthopedic research?

Frobert O, Lagerqvist B, Olivecrona G K, Omerovic E, Gudnason T, Maeng M, et al. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med 2013; 369(17): 1587-97. doi: 10.1056/NEJMoa1308789. DOI: https://doi.org/10.1056/NEJMoa1308789

Nyberg K, Hedman P. Swedish guidelines for registry-based randomized clinical trials. Ups J Med Sci 2019; 124(1): 33-6. doi: 10.1080/03009734.2018.1550453. DOI: https://doi.org/10.1080/03009734.2018.1550453

Li G, Sajobi T T, Menon B K, Korngut L, Lowerison M, James M, Wilton S B, et al. Registry-based randomized controlled trials: what are the advantages, challenges, and areas for future research? J Clin Epidemiol 2016; 80: 16-24. doi: 10.1016/j.jclinepi.2016.08.003. DOI: https://doi.org/10.1016/j.jclinepi.2016.08.003

Moller M, Wolf O, Bergdahl C, Mukka S, Rydberg E M, Hailer N P, et al. The Swedish Fracture Register: ten years of experience and 600,000 fractures collected in a National Quality Register. BMC Musculoskelet Disord 2022; 23(1): 141. doi: 10.1186/s12891-022-05062-w. DOI: https://doi.org/10.1186/s12891-022-05062-w

Wolf O, Sjoholm P, Hailer N P, Moller M, Mukka S. Study protocol: HipSTHeR – a register-based randomised controlled trial: hip screws or (total) hip replacement for undisplaced femoral neck fractures in older patients. BMC Geriatr 2020; 20(1): 19. doi: 10.1186/s12877-020-1418-2. DOI: https://doi.org/10.1186/s12877-020-1418-2

Wolf O, Mukka S, Notini M, Moller M, Hailer N P, Duality G. Study protocol: The DUALITY trial — a register-based, randomized controlled trial to investigate dual mobility cups in hip fracture patients. Acta Orthop 2020; 91(5): 506-13. doi: 10.1080/17453674.2020.1780059. DOI: https://doi.org/10.1080/17453674.2020.1780059

Mukka S, Hailer N P, Moller M, Gordon M, Lazarinis S, Rogmark C, et al. Study protocol: the DAICY trial — dual versus single-antibiotic impregnated cement in primary hemiarthroplasty for femoral neck fractur — a register-based cluster-randomized crossover-controlled trial. Acta Orthop 2022; 93: 794-800. doi: 10.2340/17453674.2022.4819. DOI: https://doi.org/10.2340/17453674.2022.4819

Sprowson A P, Jensen C, Chambers S, Parsons N, Aradhyula N M, Carluke I, et al. The use of high-dose dual-impregnated antibiotic-laden cement with hemiarthroplasty for the treatment of a fracture of the hip. Bone Joint J 2016; 98B: 1534-41. doi: 10.1302/0301-620X.98B11. DOI: https://doi.org/10.1302/0301-620X.98B11.34693

Agni N R, Costa M L, Achten J, Peckham N, Dutton S J, Png M E, et al. High-dose dual-antibiotic loaded cement for hip hemiarthroplasty in the UK (WHiTE 8): a randomised controlled trial. Lancet 2023; 402(10397): 196-202. doi: 10.1016/S0140-6736(23)00962-5. DOI: https://doi.org/10.1016/S0140-6736(23)00962-5

Blixt S, Mukka S, Forsth P, Westin O, Gerdhem P, SunBurst study group. Study protocol: the SunBurst trial — a register-based, randomized controlled trial on thoracolumbar burst fractures. Acta Orthop 2022; 93: 256-63. doi: 10.2340/17453674.2022.1614. DOI: https://doi.org/10.2340/17453674.2022.1614

Hinarejos P, Guirro P, Leal J, Montserrat F, Pelfort X, Sorli M L, et al. The use of erythromycin and colistin-loaded cement in total knee arthroplasty does not reduce the incidence of infection: a prospective randomized study in 3000 knees. J Bone Joint Surg Am 2013; 95(9): 769-74. doi: 10.2106/JBJS.L.00901. DOI: https://doi.org/10.2106/JBJS.L.00901

Leta T H, Fenstad A M, Lygre S H L, Lie S A, Lindberg-Larsen M, Pedersen A B, et al. The use of antibiotic-loaded bone cement and systemic antibiotic prophylactic use in 2,971,357 primary total knee arthroplasties from 2010 to 2020: an international register-based observational study among countries in Africa, Europe, North America, and Oceania. Acta Orthop 2023; 94: 416-25. doi: 10.2340/17453674.2023.17737. DOI: https://doi.org/10.2340/17453674.2023.17737

Leta T H, Gjertsen J E, Dale H, Hallan G, Lygre S H L, Fenstad A M, et al. Antibiotic-loaded bone cement in prevention of periprosthetic joint infections in primary total knee arthroplasty: a register-based multicentre randomised controlled non-inferiority trial (ALBA trial). BMJ Open 2021; 11(1): e041096. doi: 10.1136/bmjopen-2020-041096. DOI: https://doi.org/10.1136/bmjopen-2020-041096

Abedi A A, Varnum C, Pedersen A B, Gromov K, Hallas J, Iversen P, et al. Effect of single versus multiple prophylactic antibiotic doses on prosthetic joint infections following primary total hip arthroplasty in patients with osteoarthritis at public and private hospitals in Denmark: protocol for a nationwide cross-over, cluster randomised, non-inferiority trial [The Pro-Hip-Quality Trial]. BMJ Open 2023; 13(8): e071487. doi: 10.1136/bmjopen-2022-071487. DOI: https://doi.org/10.1136/bmjopen-2022-071487

Gundtoft P H, Overgaard S, Schonheyder H C, Moller J K, Kjaersgaard-Andersen P, Pedersen A B. The “true” incidence of surgically treated deep prosthetic joint infection after 32,896 primary total hip arthroplasties: a prospective cohort study. Acta Orthop 2015; 86(3): 326-34. doi: 10.3109/17453674.2015.1011983. DOI: https://doi.org/10.3109/17453674.2015.1011983

Gundtoft P H, Pedersen A B, Schønheyder H C, Overgaard S. Validation of the diagnosis “prosthetic joint infection” in the Danish Hip Arthroplasty Register. Bone Joint J 2016; 98-b(3): 320-5. doi: 10.1302/0301620x.98b3.36705. DOI: https://doi.org/10.1302/0301-620X.98B3.36705

MacDessi S J, Wernecke G C, Bastiras D, Hooper T, Heath E, Lorimer M, et al. Robotic-assisted surgery and kinematic alignment in total knee arthroplasty (RASKAL study): a protocol of a national registry-nested, multicentre, 2x2 factorial randomised trial assessing clinical, intraoperative, functional, radiographic and survivorship outcomes. BMJ Open 2022; 12(6): e051088. doi: 10.1136/bmjopen-2021-051088. DOI: https://doi.org/10.1136/bmjopen-2021-051088

CRISTAL Study Group; Sidhu V S, Kelly T L, Pratt N, Graves S E, Buchbinder R, et al. Effect of aspirin vs enoxaparin on symptomatic venous thromboembolism in patients undergoing hip or knee arthroplasty: the CRISTAL randomized trial. JAMA 2022; 328(8): 719-27. doi: 10.1001/jama.2022.13416. DOI: https://doi.org/10.1001/jama.2022.13416

Costa M L, Griffin X L, Achten J, Metcalfe D, Judge A, Pinedo-Villanueva R, et al. World Hip Trauma Evaluation (WHiTE): framework for embedded comprehensive cohort studies. BMJ Open 2016; 6(10): e011679. doi: 10.1136/bmjopen-2016-011679. DOI: https://doi.org/10.1136/bmjopen-2016-011679

Fernandez M A, Achten J, Parsons N, Griffin X L, Png M E, Gould J, et al. Cemented or uncemented hemiarthroplasty for intracapsular hip fracture. N Engl J Med 2022; 386(6): 521-30. doi: 10.1056/NEJMoa2108337. DOI: https://doi.org/10.1056/NEJMoa2108337