“…It is beyond the scope of the current review to delve into FDA and ASTM guidelines, but several reviews and letters have covered the topic extensively, which the reader is encouraged to read. 71,113,114 Based on the requirements of a typical clinical study, it can be said that a team of a biostatistician, an FDA regulatory consultant, a veterinarian, a biomedical engineer, an experienced orthopedic surgeon, and experts in biomechanical testing, musculoskeletal histology, and diagnostic imaging is necessary to overcome the challenges associated with clinical trials.…”