Safety assessment of microsilver-loaded poly(methyl methacrylate) (PMMA) cement spacers in patients with prosthetic hip infections: Results of a prospective cohort study

Volker Alt; Markus Rupp; Karsten Lemberger; Thorsten Bechert; Thomas Konradt; Peter Steinrücke; Reinhard Schnettler; Stephan Söder; Rudolf Ascherl

doi:10.1302/2046-3758.88.BJR-2018-0270.R1

Safety assessment of microsilver-loaded poly(methyl methacrylate) (PMMA) cement spacers in patients with prosthetic hip infections: Results of a prospective cohort study

Bone Joint Res. 2019 Sep 3;8(8):387-396. doi: 10.1302/2046-3758.88.BJR-2018-0270.R1. eCollection 2019 Aug.

Authors

Volker Alt¹, Markus Rupp², Karsten Lemberger³, Thorsten Bechert⁴, Thomas Konradt⁴, Peter Steinrücke⁴, Reinhard Schnettler⁵, Stephan Söder⁶, Rudolf Ascherl⁷

Affiliations

¹ Department of Trauma Surgery, University Hospital Regensburg, Regensburg, Germany.
² Department of Trauma, Hand and Reconstructive Surgery, University Hospital Giessen-Marburg, Campus Giessen, Giessen, Germany.
³ Department of Orthopaedics, Trauma Surgery and Sports Medicine, Asklepios Klinik Birkenwerder, Birkenwerder, Germany.
⁴ Bio-Gate AG, Nuremberg, Germany.
⁵ Department of Cranio-Maxillo-Facial Surgery, University Hospital Hamburg, Hamburg, Germany.
⁶ Institute of Pathology, Regiomed Hospital, Coburg, Germany.
⁷ Hospital for Traumatology, Special Surgery and Revision Endoprosthetic Surgery, Tirschenreuth, Germany.

PMID: 31537996
PMCID: PMC6719530
DOI: 10.1302/2046-3758.88.BJR-2018-0270.R1

Abstract

Objectives: Preclinical data showed poly(methyl methacrylate) (PMMA) loaded with microsilver to be effective against a variety of bacteria. The purpose of this study was to assess patient safety of PMMA spacers with microsilver in prosthetic hip infections in a prospective cohort study.

Methods: A total of 12 patients with prosthetic hip infections were included for a three-stage revision procedure. All patients received either a gentamicin-PMMA spacer (80 g to 160 g PMMA depending on hip joint dimension) with additional loading of 1% (w/w) of microsilver (0.8 g to 1.6 g per spacer) at surgery 1 followed by a gentamicin-PMMA spacer without microsilver at surgery 2 or vice versa. Implantation of the revision prosthesis was carried out at surgery 3.

Results: In total, 11 of the 12 patients completed the study. No argyria or considerable differences in laboratory parameters were detected. Silver blood concentrations were below or around the detection limit of 1 ppb in ten of the 11 patients. A maximum of 5.6 ppb at 48 hours after implantation of the silver spacer, which is below the recommended maximum level of 10 ppb, was found in one patient. No silver was detected in the urine. Drainage fluids showed concentrations between 16.1 ppb and 23.3 ppb at 12 hours after implantation of the silver spacers, and between 16.8 ppb to 25.1 ppb at 48 hours after implantation. Pathohistological assessment of the periprosthetic membrane did not reveal any differences between the two groups.

Conclusion: Microsilver-loaded gentamicin-PMMA spacers showed good biocompatibility and the broad antimicrobial activity warrants further clinical research to assess its effectivity in reducing infection rates in prosthetic joint infection.Cite this article: V. Alt, M. Rupp, K. Lemberger, T. Bechert, T. Konradt, P. Steinrücke, R. Schnettler, S. Söder, R. Ascherl. Safety assessment of microsilver-loaded poly(methyl methacrylate) (PMMA) cement spacers in patients with prosthetic hip infections: Results of a prospective cohort study. Bone Joint Res 2019;8:387-396. DOI: 10.1302/2046-3758.88.BJR-2018-0270.R1.

Keywords: Hip; Poly(methyl methacrylate); Prosthetic infection; Silver; Spacer.