Two-year fixation and ten-year clinical outcomes of total knee arthroplasty inserted with normal-curing bone cement and slow-curing bone cement: A randomized controlled trial in 54 patients.


Journal

The Knee
ISSN: 1873-5800
Titre abrégé: Knee
Pays: Netherlands
ID NLM: 9430798

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 20 01 2021
revised: 12 05 2021
accepted: 25 08 2021
pubmed: 8 10 2021
medline: 15 12 2021
entrez: 7 10 2021
Statut: ppublish

Résumé

The normal-curing Refobacin® Bone Cement R (RR) and slow-curing Refobacin® Plus Bone Cement (RP) were introduced after discontinuation of the historically most used bone cement, Refobacin®-Palacos® R, in 2005. The aim of this study was to compare total knee arthroplasty component fixation with the two bone cements. 54 patients with primary knee osteoarthritis were randomized to either RR (N = 27) or RP (N = 27) bone cement and followed for two years with radiostereometric analysis of tibial and femoral component migration and dual-energy x-ray absorptiometry measured periprosthetic bone mineral density (BMD). Further, patients were followed up at ten years with clinical outcome scores (OKS and KOOS). At two-years follow-up, tibial total translation was 0.31 mm (95% CI: 0.19 - 0.42) for the RP group and 0.56 mm (95% CI: 0.45 - 0.67) (p < 0.01) for the RR group. There was continuous tibial component migration from one to two years follow-up (MTPM > 0.2 mm) in 13/27 patients from the RR and in 12/26 patients from the RP group. There was no difference between groups in BMD baseline values or changes during follow-up, as well as no correlation between change in BMD and tibial component migration. At ten-years follow-up, the improvement in the clinical outcome scores was similar between groups. There were no prosthesis related complications during the 10-year follow-up. At two years, tibial total translation was lower in the RP compared with the RR cement group, but BMD changes were similar. At ten years, no components were revised and clinical outcome scores were similar between groups.

Sections du résumé

BACKGROUND BACKGROUND
The normal-curing Refobacin® Bone Cement R (RR) and slow-curing Refobacin® Plus Bone Cement (RP) were introduced after discontinuation of the historically most used bone cement, Refobacin®-Palacos® R, in 2005. The aim of this study was to compare total knee arthroplasty component fixation with the two bone cements.
METHODS METHODS
54 patients with primary knee osteoarthritis were randomized to either RR (N = 27) or RP (N = 27) bone cement and followed for two years with radiostereometric analysis of tibial and femoral component migration and dual-energy x-ray absorptiometry measured periprosthetic bone mineral density (BMD). Further, patients were followed up at ten years with clinical outcome scores (OKS and KOOS).
RESULTS RESULTS
At two-years follow-up, tibial total translation was 0.31 mm (95% CI: 0.19 - 0.42) for the RP group and 0.56 mm (95% CI: 0.45 - 0.67) (p < 0.01) for the RR group. There was continuous tibial component migration from one to two years follow-up (MTPM > 0.2 mm) in 13/27 patients from the RR and in 12/26 patients from the RP group. There was no difference between groups in BMD baseline values or changes during follow-up, as well as no correlation between change in BMD and tibial component migration. At ten-years follow-up, the improvement in the clinical outcome scores was similar between groups. There were no prosthesis related complications during the 10-year follow-up.
CONCLUSION CONCLUSIONS
At two years, tibial total translation was lower in the RP compared with the RR cement group, but BMD changes were similar. At ten years, no components were revised and clinical outcome scores were similar between groups.

Identifiants

pubmed: 34619515
pii: S0968-0160(21)00211-8
doi: 10.1016/j.knee.2021.08.027
pii:
doi:

Substances chimiques

Bone Cements 0

Types de publication

Journal Article Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

110-124

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Sebastian Breddam Mosegaard (S)

Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark. Electronic address: sebmos@rm.dk.

Søren Rytter (S)

Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark. Electronic address: soeren.rytter@rm.dk.

Frank Madsen (F)

Department of Orthopaedic Surgery, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: franmads@rm.dk.

Anders Odgaard (A)

Department of Orthopaedic Surgery, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark. Electronic address: anders.odgaard@regionh.dk.

Kjeld Søballe (K)

Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark.

Maiken Stilling (M)

Department of Clinical Medicine, Aarhus University, Palle Juul-Jensens Boulevard 99, 8200 Aarhus N, Denmark; Department of Orthopaedic Surgery, Aarhus University Hospital, Palle Juul-Jensens Boulevard 165, 8200 Aarhus N, Denmark. Electronic address: maiken.stilling@clin.au.dk.

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