Evaluation of Prepacked Bone Cement Mixing Systems in Arthroplasty: Implications for Intraoperative Hygiene and Contamination Risk

In cemented endoprosthetics, closed prepacked mixing systems represent the most advanced generation of cementing technology. (1) Background: The purpose of the present study is to evaluate four approved prepacked systems—Palacos® R+G pro, SmartMix™ Cemvac GHV, Optipac® Refobacin and Cemex® System Genta—with a focus on practical handling and intraoperative hygiene. (2) Method: The systems were evaluated according to established standard test methods for bone cements (ISO 5833), including dough time, setting time, additional mechanical tests and the level of system closure. (3) Results: The results show that all systems are safe to use and meet the general requirements, but there are relevant differences in terms of intraoperative hygiene. The Palacos R+G pro system shows significantly shorter doughing and setting times, which helps to minimize wound exposure during surgery and thus significantly reduces the overall operating time and the risk of bacterial contamination. Two of the systems cannot be classified as completely closed “pre-packaged systems.” In two cases, the system must be temporarily opened before mixing to insert the mixing element, which may result in a temporary but clinically relevant impairment of sterility and a corresponding potential risk of contamination. (4) Conclusion: From a hygienic point of view, systems that remain completely closed throughout the entire preparation process can offer advantages in terms of infection prevention. This was the case for all systems tested. Short handling times, reduced exposure of the surgical site and a shorter overall duration of the procedure could further improve intraoperative safety and reduce the risk of contamination. In terms of intraoperative hygiene, the Palacos R+G pro system achieved the best results compared to the three other systems tested due to its rapid readiness for use and comparatively short setting time (according to ISO 5833). Cemex System Genta performed worst in this respect due to its late doughing time and setting time.

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Publication Details

Journal
Hygiene
Published
2025-09-04
DOI
https://doi.org/10.3390/hygiene5030040
Primary Topic
Orthopaedic implants and arthroplasty
Type
article
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article

Evaluation of Prepacked Bone Cement Mixing Systems in Arthroplasty: Implications for Intraoperative Hygiene and Contamination Risk

Christian Paúl, Pablo Sanz-Ruíz, Klaus‐Dieter Kühn, Muhamed Zeneli
Hygiene
Orthopaedic implants and arthroplasty
article

Evaluation of Prepacked Bone Cement Mixing Systems in Arthroplasty: Implications for Intraoperative Hygiene and Contamination Risk

Christian Paúl, Pablo Sanz-Ruíz, Klaus‐Dieter Kühn, Muhamed Zeneli
article en

Abstract

In cemented endoprosthetics, closed prepacked mixing systems represent the most advanced generation of cementing technology. (1) Background: The purpose of the present study is to evaluate four approved prepacked systems—Palacos® R+G pro, SmartMix™ Cemvac GHV, Optipac® Refobacin and Cemex® System Genta—with a focus on practical handling and intraoperative hygiene. (2) Method: The systems were evaluated according to established standard test methods for bone cements (ISO 5833), including dough time, setting time, additional mechanical tests and the level of system closure. (3) Results: The results show that all systems are safe to use and meet the general requirements, but there are relevant differences in terms of intraoperative hygiene. The Palacos R+G pro system shows significantly shorter doughing and setting times, which helps to minimize wound exposure during surgery and thus significantly reduces the overall operating time and the risk of bacterial contamination. Two of the systems cannot be classified as completely closed “pre-packaged systems.” In two cases, the system must be temporarily opened before mixing to insert the mixing element, which may result in a temporary but clinically relevant impairment of sterility and a corresponding potential risk of contamination. (4) Conclusion: From a hygienic point of view, systems that remain completely closed throughout the entire preparation process can offer advantages in terms of infection prevention. This was the case for all systems tested. Short handling times, reduced exposure of the surgical site and a shorter overall duration of the procedure could further improve intraoperative safety and reduce the risk of contamination. In terms of intraoperative hygiene, the Palacos R+G pro system achieved the best results compared to the three other systems tested due to its rapid readiness for use and comparatively short setting time (according to ISO 5833). Cemex System Genta performed worst in this respect due to its late doughing time and setting time.

HygieneVol. 5(3)
Justus-Liebig-Universität Gießen (DE), Medical University of Graz (AT), Hospital General Universitario Gregorio Marañón (ES), Heraeus (Germany) (DE)
Openalex Percentile: Top 62%
Orthopaedic implants and arthroplasty
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