Minimum performance level definition for bone plate testing according to standard: A preliminary study

In silico modeling of osteosynthesis medical devices allows the reduction of the time required for experimental tests and the introduction of “simulation-driven design”. Using a wise combination of these techniques and analytical calculations, it is possible to relate the experimental results, which are mandatory for regulatory purposes, to the plate physiological application and prevent the occurrence of complications in the early stages after the orthopedic device implantation on humans and animals.

Comparative Study on Law Relating to Orthopedic Implants in India, United States and European Union with Case Study

Background: The article provides brief discussion on the comparative regulations on orthopedic implants in India, United States and European Union. Orthopedic implants are tone of the high risk medical devices manufactured to substitute or replace a missing or damaged joint or bone or to support a damaged bone or joint and to improve the quality of life of patients. Thus, there is a need to regulate the import, manufacture, clinical investigation; sale and distribution of orthopedic implants to ensure that all orthopedic implants that were brought to market are safe, quality and performance. The orthopedic implants industry is adversely affected by lack of awareness on proper regulatory practices, lack of awareness on the current regulatory practices, separate consistent standards, separate lawful requirements, and proper guidance on quality system etc. Conclusion: The objective of this article is to harmonize the regulatory requirements at par with the internationally accepted regulations and to develop ecosystem in the country to boost the Indian orthopedic device sector, and that will make India more productive for orthopedic device development to encourage national and multinational orthopedic implants industries to manufacture their orthopedic implants in India.

Cutibacterium acnes clonal complexes display various growth rates in blood-culture bottles used for diagnosing orthopedic device-related infections

ABSTRACTBlood-culture bottles (BCBs) are widely used to improve the diagnosis of orthopedic device-related infections. Data is scarce on the growth of Cutibacterium acnes and its genotypes in BCBs under real-life clinical conditions.We studied 39 cases of revision arthroplasty for which at least one intraoperative sample yielded a pure C. acnes culture from anaerobic BCBs (BD Bactec Lytic/10 Anaerobic/F [Lytic Ana]) and/or solid media. Genotyping of C. acnes isolates from the 39 cases allowed: i) the identification of 49 non-redundant isolates belonging to four clonal complexes (CCs): CC18, CC28, CC36, and CC53 and ii) the determination of infectant and contaminant strains. Under real-life clinical conditions, Lytic Ana alone was more often positive for contaminants than infectant strains (18/36 [50%] versus 2/13 [15.4%]; p = 0.047). The time to detection (TTD) values in Lytic Ana were shorter for CC53 than other CCs (mean [SD] TTD: 77 [15] versus 165 [71] hours; p = 0.02). CC53 was confirmed to grow faster than other CCs by studying an enlarged panel of 70 genotyped C. acnes strains inoculated in vitro into Lytic Ana vials (mean [SD] TTD: 73 [13] versus 122 [50] hours; p < 0.001).The use of Lytic Ana BCBs in orthopedics increases the recovery rate of C. acnes but leads to the isolation of proportionally more contaminants than true infectant strains. TTD values are much shorter for CC53 strains, irrespective of their being infectant or contaminant. TTD does not solely reflect the bacterial load of samples but also clonal complex-related traits.

Based on the synergistic effect of Mg2+ and antibacterial peptides to improve the corrosion resistance, antibacterial ability and osteogenic activity of magnesium-based degradable metals

Magnesium (Mg) and its alloys have been widely investigated as the most promising biodegradable metals for orthopedic device applications, but its surface properties should be further improved to overcome the restricted osteogenesis and fast degradation problems.

Antibacterial peptidomimetic and characterization of its efficacy as an antibacterial and biocompatible coating for bioceramic-based bone substitutes

Novel strategies to combat orthopedic device related infections are the need of the hour. We have synthesized an antibacterial peptidomimetic and characterized its suitability as a non-covalent coating material for bioceramic hydroxyapatite discs.