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)
Anne Marie Fenstad,
Stig Heir,
Jan-Erik Gjertsen,
Håvard Dale,
Marianne Westberg,
Rune Bruhn Jakobsen,
Arild Aamodt,
Ove Furnes,
Tesfaye H Leta,
Geir Hallan,
Stein Håkon Låstad Lygre,
Gro Sævik Dyrhovden,
Tina Stromdal Wik,
Stephan Maximillian Röhrl,
Øystein Johannes Gøthesen,
Einar Lindalen,
Jarle Ludvigsen,
Trond Bruun,
Ann Kristin Hansen,
Knut Erik Moen Aune,
Marianne Warholm,
John Petter Skjetne,
Mona Badawy,
Pål Høvding,
Otto Schnell Husby,
Øystein Espeland Karlsen
Affiliations
Anne Marie Fenstad
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Stig Heir
Department of Orthopedic Surgery, Martina Hansens Hospital, Sandvika, Norway
Jan-Erik Gjertsen
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Håvard Dale
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Marianne Westberg
Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway
Rune Bruhn Jakobsen
Department of Health Management and Health Economics, University of Oslo, Oslo, Norway
Arild Aamodt
Department of Orthopaedic Surgery, Lovisenberg Diakonal Hospital, Oslo, Norway
Ove Furnes
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Tesfaye H Leta
Faculty of Health Science, VID Specialized University, Bergen, Norway
Geir Hallan
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Stein Håkon Låstad Lygre
Department of Occupational Medicine, Haukeland University Hospital, Bergen, Norway
Gro Sævik Dyrhovden
Department of Clinical Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway
Tina Stromdal Wik
Department of Orthopedic Surgery, St. Olavs Hospital, Trondheim, Norway
Stephan Maximillian Röhrl
Division of Orthopedic Surgery, Oslo University Hospital, Oslo, Norway
Øystein Johannes Gøthesen
Department of Clinical Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway
Einar Lindalen
Department of Orthopaedic Surgery, Lovisenberg Diakonal Hospital, Oslo, Norway
Jarle Ludvigsen
Department of Orthopedic Surgery, Stavanger University Hospital, Stavanger, Norway
Trond Bruun
Department of Medicine, Haukeland University Hospital, Bergen, Norway
Ann Kristin Hansen
Department of Orthopedic Surgery, University Hospital of North Norway, Tromsø, Norway
Knut Erik Moen Aune
Department of Orthopedic Surgery, Namsos Hospital, Namsos, Norway
Marianne Warholm
Department of Information and Communication Technology, Western Norway Regional Health Authority, Bergen, Norway
John Petter Skjetne
Department of Information and Technology, Central Norway Regional Health Authority, Trondheim, Norway
Mona Badawy
Coastal Hospital in Hagavik, Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway
Pål Høvding
The Norwegian Arthroplasty Register, Department of Orthopedic Surgery, Haukeland University Hospital, Bergen, Norway
Otto Schnell Husby
Department of Orthopedic Surgery, St. Olavs Hospital, Trondheim, Norway
Øystein Espeland Karlsen
Department of Orthopedic Surgery, Betanien Hospital, Skien, Norway
Introduction The current evidence on the efficacy of antibiotic-loaded bone cement (ALBC) in reducing the risk of periprosthetic joint infections (PJI) after primary joint reconstruction is insufficient. In several European countries, the use of ALBC is routine practice unlike in the USA where ALBC use is not approved in low-risk patients. Therefore, we designed a double-blinded pragmatic multicentre register-based randomised controlled non-inferiority trial to investigate the effects of ALBC compared with plain bone cement in primary total knee arthroplasty (TKA).Methods and analysis A minimum of 9,172 patients undergoing full-cemented primary TKA will be recruited and equally randomised into the ALBC group and the plain bone cement group. This trial will be conducted in Norwegian hospitals that routinely perform cemented primary TKA. The primary outcome will be risk of revision surgery due to PJI at 1-year of follow-up. Secondary outcomes will be: risk of revision due to any reason including aseptic loosening at 1, 6, 10 and 20 years of follow-up; patient-related outcome measures like function, pain, satisfaction and health-related quality of life at 1, 6 and 10 years of follow-up; risk of changes in the microbial pattern and resistance profiles of organisms cultured in subsequent revisions at 1, 6, 10 and 20 years of follow-up; cost-effectiveness of routine ALBC versus plain bone cement use in primary TKA. We will use 1:1 randomisation with random permuted blocks and stratify by participating hospitals to randomise patients to receive ALBC or plain bone cement. Inclusion, randomisation and follow-up will be through the Norwegian Arthroplasty Register.Ethics and dissemination The trial was approved by the Western Norway Regional Committees on Medical and Health Research Ethics (reference number: 2019/751/REK vest) on 21 June 2019. The findings of this trial will be disseminated through peer-reviewed publications and conference presentations.Trial registration number NCT04135170.
