title: Performance of bone cements: are current preclinical specifications adequate?
abstract: BACKGROUND
  Current specifications (standards) for preclinical testing of bone cements (ISO 5833: 2002, ASTM F451-99a) require simple mechanical testing after ageing for 24 h under dry conditions at 23 degrees C. Some bone cements have fulfilled the requirements in the specifications, and yet had inferior clinical results. Clinically, bone cements are subjected to complex loading patterns in a moist or wet environment at 37 degrees C. Thus, both the validity and the robustness of current standard testing protocols can be questioned.
  
  
  METHODS
  We examined the influence of temperature and storage medium on the properties of bone cement. We also compared the results of storage and testing under standard conditions of 23 degrees C in dry air, with the results obtained at 37 degrees C in water or plasma.
  
  
  RESULTS
  The dry specimens showed an increase in strength and elastic modulus with time, while the values of the wet ones decreased. There was no difference between specimens stored in water or in plasma. Ultimate compressive strength of dry specimens after 24 h was 1.16 times higher than that of the ones stored wet, increasing to 1.34 times after 1 month, and 1.46 times after 6 months (p<0.001 for all comparisons).
  
  
  CONCLUSIONS
  Testing under dry conditions-as required in current standards-always gave higher values for mechanical properties than did storage and testing under more physiological conditions. The sensitivity of test values to different environments implies that testing conditions for bone cements should be scrutinized in order to develop more relevant testing protocols that reflect the in vivo environment more closely.
authors.affiliation: Department of Orthopaedic Surgery, Haukeland University Hospital, Bergen, Norway. mkamn@kir.uib.no
authors.forename: Markus
authors.initials: M
authors.lastname: Nottrott
authors.forename: Anders O
authors.initials: AO
authors.lastname: Mølster
authors.forename: Irene O
authors.initials: IO
authors.lastname: Moldestad
authors.forename: William R
authors.initials: WR
authors.lastname: Walsh
authors.forename: Nils R
authors.initials: NR
authors.lastname: Gjerdet
mesh_terms: D001843:Bone Cements / Q000592:standards*; D019245:Compressive Strength; D006801:Humans; D008422:Materials Testing / Q000592:standards*; D013314:Stress, Mechanical
chemical_list: D001843:Bone Cements