Mechanical Testing of Device
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Biodegradability Testing of Polymer
- Testing the rate of degradation and the changes in mechanical properties of 10 specimens of PGA with a surface area to volume ratio identical to that of the final fixation device
- Time intervals: t = 0 weeks, 4 weeks, 8 weeks, 12 weeks, and 15 weeks
- Body fluid simulated with Ringer’s Lactate solution at 37° C
- Specimens will be weighed and will be tested mechanically. The pH of the solution will also be taken
Biocompatibility Testing
- For our purposes, animal and human testing is costly, time consuming, and virtually impossible to implement in the available facilities at The College of New Jersey.
- All materials utilized in this device design (PGA & PLLA) have been previously implanted in humans during clinical trials for a variety of devices, including surgical screws, sutures, and fixation pins.
- The literature
evidence of human acceptance of the device materials throughout the degradation
process is sufficient to justify eliminating biocompatibility testing.