<p>The Codubix implant—a polypropylene-polyester (PP/PEK) braid is characterized by high biological compatibility, mechanical strength, resistance to bending forces and infections. This material, with cranioplastic properties similar to the parameters of natural bone, ensures high safety of use, and due to its porosity promotes rapid tissue overgrowth. The aim of the retrospective analysis was to assess the efficacy and safety of using cranial vault prostheses made of this material. The study included 121 patients (93 men, 28 women) from four clinical centers. The participants were divided into two groups based on the type of implanted prosthesis and the implant fixation system. Intraoperative data and information collected during two follow-up visits and the final interview with the patients were analyzed. Both standard prostheses (45) and customized variants (76) were used for implantation. Bone sutures and titanium clamps were used for fixation. Both methods ensured a stable fixation of the prosthesis. In the studied patient population, prostheses were an effective and safe method of filling bone defects of the skull cap providing high comfort (79.3%) and good cosmetic effect (62.0%). The size of the defect did not affect the recovery time, patient comfort or occurrence of postoperative complications. The average surgery time for implanting the individually adapted prostheses was approximately 70&#xa0;min, while for the standard prostheses the average time was approximately 104&#xa0;min. The CranioFix titanium clamps were used more often than other fixation methods. The study also examined the relationship between the fixation system and the surgical time. The surgeries with clamps lasted an average of 31&#xa0;min longer than the ones with bone sutures. The time of the procedure depends on many factors, including the complexity of the surgery or the medical case.</p>

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Evaluation of efficacy and safety of use of Codubix and Codubix S cranial implants

  • Piotr Kasprzak,
  • Dariusz J. Jaskólski,
  • Radosław Rola,
  • Klaudia Kuś-Budzyńska,
  • Paula Złakowska,
  • Dariusz Szczepanek,
  • Mateusz Szostak,
  • Grzegorz Tomaszewski,
  • Magdalena Tokarska,
  • Kaja Jezierska,
  • Witold Sujka

摘要

The Codubix implant—a polypropylene-polyester (PP/PEK) braid is characterized by high biological compatibility, mechanical strength, resistance to bending forces and infections. This material, with cranioplastic properties similar to the parameters of natural bone, ensures high safety of use, and due to its porosity promotes rapid tissue overgrowth. The aim of the retrospective analysis was to assess the efficacy and safety of using cranial vault prostheses made of this material. The study included 121 patients (93 men, 28 women) from four clinical centers. The participants were divided into two groups based on the type of implanted prosthesis and the implant fixation system. Intraoperative data and information collected during two follow-up visits and the final interview with the patients were analyzed. Both standard prostheses (45) and customized variants (76) were used for implantation. Bone sutures and titanium clamps were used for fixation. Both methods ensured a stable fixation of the prosthesis. In the studied patient population, prostheses were an effective and safe method of filling bone defects of the skull cap providing high comfort (79.3%) and good cosmetic effect (62.0%). The size of the defect did not affect the recovery time, patient comfort or occurrence of postoperative complications. The average surgery time for implanting the individually adapted prostheses was approximately 70 min, while for the standard prostheses the average time was approximately 104 min. The CranioFix titanium clamps were used more often than other fixation methods. The study also examined the relationship between the fixation system and the surgical time. The surgeries with clamps lasted an average of 31 min longer than the ones with bone sutures. The time of the procedure depends on many factors, including the complexity of the surgery or the medical case.