STUDY DESIGN: In vitro studies on the mechanical strength of 70/30 poly(l,dl-lactic acid) (70/30 PLDLLA) cages. OBJECTIVE: To evaluate the effect of loading rate, humidity, temperature, and continuous static loading on the strength of 70/30 PLDLLA, to elucidate the mechanism of premature failure of degradable spinal cages observed in earlier studies. SUMMARY OF BACKGROUND DATA: Degradable 70/30 PLDLLA cages have been designed to withstand mechanical loads in a goat lumbar spine for at least 6 months. Yet mechanical failure was observed after only 3 months in vivo. We hypothesize that this observation can be related to the time-dependent nature of the polymer. METHODS: Degradable 70/30 PLDLLA cages were loaded to failure at loading rates between 10 and 10 mm/s under standard loading conditions (in air at room temperature: +/-23 degrees C). The experiments were also done at body temperature (37 degrees C) and under wet conditions. Furthermore, we determined the time-to-failure for 70/30 PLDLLA cages subjected to loads well below their instantaneous mechanical strength. RESULTS: The mechanical strength of 70/30 PLDLLA cages was lower for lower loading rates, higher temperature, and higher humidity. The cages already failed within less than 5 minutes when statically loaded at 75% of their strength, and within 1 day when loaded at about 50% of their strength. Extrapolation predicts cage failure at 3 months when loaded at 25% of their strength. CONCLUSION: Premature failure of 70/30 PLDLLA cages, as observed in vivo in earlier studies, is owing to mechanical loading and the time-dependent mechanical properties of the material. The standards for mechanical testing of implants made of strongly time-dependent materials like polylactide should be reconsidered.
STUDY DESIGN: In vitro studies on the mechanical strength of 70/30 poly(l,dl-lactic acid) (70/30 PLDLLA) cages. OBJECTIVE: To evaluate the effect of loading rate, humidity, temperature, and continuous static loading on the strength of 70/30 PLDLLA, to elucidate the mechanism of premature failure of degradable spinal cages observed in earlier studies. SUMMARY OF BACKGROUND DATA: Degradable 70/30 PLDLLA cages have been designed to withstand mechanical loads in a goat lumbar spine for at least 6 months. Yet mechanical failure was observed after only 3 months in vivo. We hypothesize that this observation can be related to the time-dependent nature of the polymer. METHODS: Degradable 70/30 PLDLLA cages were loaded to failure at loading rates between 10 and 10 mm/s under standard loading conditions (in air at room temperature: +/-23 degrees C). The experiments were also done at body temperature (37 degrees C) and under wet conditions. Furthermore, we determined the time-to-failure for 70/30 PLDLLA cages subjected to loads well below their instantaneous mechanical strength. RESULTS: The mechanical strength of 70/30 PLDLLA cages was lower for lower loading rates, higher temperature, and higher humidity. The cages already failed within less than 5 minutes when statically loaded at 75% of their strength, and within 1 day when loaded at about 50% of their strength. Extrapolation predicts cage failure at 3 months when loaded at 25% of their strength. CONCLUSION:Premature failure of 70/30 PLDLLA cages, as observed in vivo in earlier studies, is owing to mechanical loading and the time-dependent mechanical properties of the material. The standards for mechanical testing of implants made of strongly time-dependent materials like polylactide should be reconsidered.
Authors: Ashleen R Knutsen; Sean L Borkowski; Edward Ebramzadeh; Colleen L Flanagan; Scott J Hollister; Sophia N Sangiorgio Journal: J Mech Behav Biomed Mater Date: 2015-05-27