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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)

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...

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Autores principales: Leta, Tesfaye H, Gjertsen, Jan-Erik, Dale, Håvard, Hallan, Geir, Lygre, Stein Håkon Låstad, Fenstad, Anne Marie, Dyrhovden, Gro Sævik, Westberg, Marianne, Wik, Tina Stromdal, Jakobsen, Rune Bruhn, Aamodt, Arild, Röhrl, Stephan Maximillian, Gøthesen, Øystein Johannes, Lindalen, Einar, Heir, Stig, Ludvigsen, Jarle, Bruun, Trond, Hansen, Ann Kristin, Aune, Knut Erik Moen, Warholm, Marianne, Skjetne, John Petter, Badawy, Mona, Høvding, Pål, Husby, Otto Schnell, Karlsen, Øystein Espeland, Furnes, Ove
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845702/
https://www.ncbi.nlm.nih.gov/pubmed/33509845
http://dx.doi.org/10.1136/bmjopen-2020-041096
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author Leta, Tesfaye H
Gjertsen, Jan-Erik
Dale, Håvard
Hallan, Geir
Lygre, Stein Håkon Låstad
Fenstad, Anne Marie
Dyrhovden, Gro Sævik
Westberg, Marianne
Wik, Tina Stromdal
Jakobsen, Rune Bruhn
Aamodt, Arild
Röhrl, Stephan Maximillian
Gøthesen, Øystein Johannes
Lindalen, Einar
Heir, Stig
Ludvigsen, Jarle
Bruun, Trond
Hansen, Ann Kristin
Aune, Knut Erik Moen
Warholm, Marianne
Skjetne, John Petter
Badawy, Mona
Høvding, Pål
Husby, Otto Schnell
Karlsen, Øystein Espeland
Furnes, Ove
author_facet Leta, Tesfaye H
Gjertsen, Jan-Erik
Dale, Håvard
Hallan, Geir
Lygre, Stein Håkon Låstad
Fenstad, Anne Marie
Dyrhovden, Gro Sævik
Westberg, Marianne
Wik, Tina Stromdal
Jakobsen, Rune Bruhn
Aamodt, Arild
Röhrl, Stephan Maximillian
Gøthesen, Øystein Johannes
Lindalen, Einar
Heir, Stig
Ludvigsen, Jarle
Bruun, Trond
Hansen, Ann Kristin
Aune, Knut Erik Moen
Warholm, Marianne
Skjetne, John Petter
Badawy, Mona
Høvding, Pål
Husby, Otto Schnell
Karlsen, Øystein Espeland
Furnes, Ove
author_sort Leta, Tesfaye H
collection PubMed
description 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.
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spelling pubmed-78457022021-02-04 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) Leta, Tesfaye H Gjertsen, Jan-Erik Dale, Håvard Hallan, Geir Lygre, Stein Håkon Låstad Fenstad, Anne Marie Dyrhovden, Gro Sævik Westberg, Marianne Wik, Tina Stromdal Jakobsen, Rune Bruhn Aamodt, Arild Röhrl, Stephan Maximillian Gøthesen, Øystein Johannes Lindalen, Einar Heir, Stig Ludvigsen, Jarle Bruun, Trond Hansen, Ann Kristin Aune, Knut Erik Moen Warholm, Marianne Skjetne, John Petter Badawy, Mona Høvding, Pål Husby, Otto Schnell Karlsen, Øystein Espeland Furnes, Ove BMJ Open Surgery 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. BMJ Publishing Group 2021-01-28 /pmc/articles/PMC7845702/ /pubmed/33509845 http://dx.doi.org/10.1136/bmjopen-2020-041096 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Surgery
Leta, Tesfaye H
Gjertsen, Jan-Erik
Dale, Håvard
Hallan, Geir
Lygre, Stein Håkon Låstad
Fenstad, Anne Marie
Dyrhovden, Gro Sævik
Westberg, Marianne
Wik, Tina Stromdal
Jakobsen, Rune Bruhn
Aamodt, Arild
Röhrl, Stephan Maximillian
Gøthesen, Øystein Johannes
Lindalen, Einar
Heir, Stig
Ludvigsen, Jarle
Bruun, Trond
Hansen, Ann Kristin
Aune, Knut Erik Moen
Warholm, Marianne
Skjetne, John Petter
Badawy, Mona
Høvding, Pål
Husby, Otto Schnell
Karlsen, Øystein Espeland
Furnes, Ove
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)
title 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)
title_full 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)
title_fullStr 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)
title_full_unstemmed 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)
title_short 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)
title_sort 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)
topic Surgery
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7845702/
https://www.ncbi.nlm.nih.gov/pubmed/33509845
http://dx.doi.org/10.1136/bmjopen-2020-041096
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