Evaluation of acrylic bone cements and their performance standards

Area of Science:

• Biomaterials Science
• Orthopedic Surgery
• Materials Testing

Background:

• Acrylic bone cements are widely used in orthopedic procedures.
• Standardized testing is crucial for ensuring the safety and efficacy of bone cements.
• Previous evaluations have highlighted variations in product performance against established standards.

Purpose of the Study:

• To evaluate eight acrylic bone cement products against three international performance standards.
• To assess compliance with physical, chemical, and sterility requirements.
• To identify limitations in current testing methodologies and suggest improvements.

Main Methods:

• Products were tested according to Australian Standard 2265 Part 1, 1979, ASTM specification F451-76, and ISO specification 5833/1, 1979.
• Chemical composition was analyzed using Gas Chromatography (GC), Nuclear Magnetic Resonance (NMR), and Infrared (IR) spectroscopy.
• Refractive index measurements were also performed.

Main Results:

• All products complied with the physical, compositional, and sterility requirements of AS 2265.
• One product failed to meet the solubility requirements of ASTM F451-76.
• None of the products met the doughing time requirements of ISO 5833/1.
• Noncompliance was also observed in product labeling and insert information.

Conclusions:

• The water solubility and sorption requirements of ASTM F451-76 may be overly restrictive.
• The doughing time test methodology in ISO 5833/1 requires modification.
• Standards should consider incorporating clauses for mixing tools and radiopacity.
• Further refinement of bone cement testing standards is necessary for accurate performance evaluation.