Influence of thermodisinfection and duration of cryopreservation at different temperatures on pull out strength of cancellous bone.

Thermodisinfection of human femoral heads from living donors harvested during hip joint replacement is an established processing procedure. This study was designed to examine the influence of heat sterilization on pull out strength of cancellous bone and storage at different temperatures up to 2 years since we had previously studied the storage of unprocessed cancellous bone. Porcine cancellous bone resembling human bone structure was obtained from 140 proximal humerus of 6-8 months old piglets. Pull out strength of screws after thermodisinfection was compared with unprocessed cancellous bone and tested immediately and after 6, 12 and 24 months of storage at -20 and -80 °C. A three-way ANOVA was performed and significance level was 5 %. The thermodisinfected bone showed a pull out force of 2729 N (1657-3568 N). The reduction of pull out strength compared with unprocessed bone over all periods of storage was 276 N on average with 95 % confidence interval ranging from 166 N to 389 N (p < 0.0001). Different freezing temperatures did not influence this mechanic property within 24 months storage and showed no difference compared with fresh frozen bone. Thermodisinfection of cancellous bone preserves tensile strength necessary for clinical purposes. The storage at -20 °C for at least 2 years did not show relevant decrease of pull out strength compared with -80 °C without difference between thermodisinfected and fresh frozen bone. The increase of the storage temperature to -20 °C for at least 2 years should be considered.

Effect of Storage Temperature on Allograft Bone.

BACKGROUND: The recommendations for storage temperature of allogeneic bone are varying between -20 °C and -70 °C and down to -80 °C. The necessary temperature of storage is not exactly defined by scientific data, and the effect of different storage temperatures onto the biomechanical and the biological behavior is discussed controversially. METHODS: The historical development of storage temperature of bone banks is described. A survey on literature concerning the biomechanical and biological properties of allograft bone depending on the procurement and storage temperature is given as well as on national and international regulations on storage conditions of bone banks (European Council, American Association of Tissue Banks (AATB), European Association of Tissue Banks (EATB)). RESULTS: Short-term storage up to 6 months is recommended with -20 °C and -40 °C for a longer period (AATB), and EATB recommends storage at -40 °C and even -80 °C while the regulations of the German German Medical Association (Bundesärztekammer) from 2001 recommend storage at -70 °C. Duration of storage at -20 °C can be maintained at least for 2 years. The potential risk of proteolysis with higher storage temperatures remains, but a definite impairment of bone ingrowth due to a storage at -20 °C was not shown in clinical use, and no adverse biomechanical effects of storage at -20 °C could be proven. CONCLUSION: Biomechanical studies showed no clinically relevant impairment of biomechanical properties of cancellous bone due to different storage temperatures. Sterilization procedures bear the advantage of inactivating enzymatic activity though reducing the risk of proteolysis. In those cases a storage temperature of -20 °C can be recommended for at least a period of 2 years, and the risk of undesired effects seems to be low for native unprocessed bone.