Antibiotic Loaded Bone Cement in Prevention of Periprosthetic Joint Infections in Primary Total Knee Arthroplasty

Author(s):  
BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e041096
Author(s):  
Tesfaye H Leta ◽  
Jan-Erik Gjertsen ◽  
Håvard Dale ◽  
Geir Hallan ◽  
Stein Håkon Låstad Lygre ◽  
...  

IntroductionThe 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 analysisA 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 disseminationThe 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 numberNCT04135170.


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Hans Bösebeck ◽  
Anna-Maria Holl ◽  
Peter Ochsner ◽  
Manuel Groth ◽  
Kevin Stippich ◽  
...  

Abstract Background In cemented primary total knee arthroplasty (TKA), aseptic loosening remains a major cause for failure. Cementing techniques and characteristics of a chosen cement play a key role for good fixation and implant survival. A pastry bone cement was developed to facilitate the cement preparation and to rule out most of preparation-associated application errors. The pastry bone cement was compared to a conventional polymethyl methacrylate cement in a TKA setting. Methods Standardized implantations of total knee endoprostheses were performed in bilateral knee cadavers to investigate handling properties, variables of cement application, working time, and temperature development. Mechanical aspects and cementation quality were assessed by pull-out trials and microscopic interface analysis. Results Both cements expressed similar characteristics during preparation and application, only the curing time of the pastry cement was about 3 min longer and the temperature peak was lower. Fractures of the conventional cement specimens differed from the pastry cement specimens in the tibial part, while no differences were found in the femoral part. Penetration depth of the pastry cement was similar (tibia) or deeper (femur) compared to the conventional cement. Conclusions The pastry cement facilitates the feasibility of cemented TKA. The pre-clinical tests indicate that the pastry bone cement fulfills the requirements for bone cement in the field of knee arthroplasty. A clinical trial is needed to further investigate the approach and ensure patient safety.


2020 ◽  
Vol 102 (22) ◽  
pp. 1939-1947
Author(s):  
Ilya Bendich ◽  
Ning Zhang ◽  
Jeffrey J. Barry ◽  
Derek T. Ward ◽  
Mary A. Whooley ◽  
...  

Orthopedics ◽  
2015 ◽  
Vol 38 (6) ◽  
pp. e462-e466 ◽  
Author(s):  
Hai Wang ◽  
Gui-Xing Qiu ◽  
Jin Lin ◽  
Jin Jin ◽  
Wen-Wei Qian ◽  
...  

2016 ◽  
Vol 24 (10) ◽  
pp. 3168-3174 ◽  
Author(s):  
A. Schiavone Panni ◽  
K. Corona ◽  
M. Giulianelli ◽  
G. Mazzitelli ◽  
C. Del Regno ◽  
...  

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