A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis.

There was no separate control group; participants were compared only with their own conventional device. Only 22 of 26 participants completed, and four did not return for follow-up. The trial lasted only two weeks, so it does not show long-term comfort, durability, or skin safety. Gait testing was done in 17 participants; 3 had bilateral transtibial amputations and were not tested, and 2 could not be tested because of equipment repair. Participants were volunteers who may have had less favorable views of their conventional devices and were motivated to try the new device. The pressure film was less accurate for precise pressure values, though it was useful for relative differences. At six months, only 17 participants were contacted, so continued use was not known for all. The device was bulkier for some users, and they needed pants with larger legs. The study tested the whole IFIT prosthesis, including its socket, liner, buckle, and foot. The contribution of any single component cannot be separated. Exclusions included open skin lesions, excessive phantom pain, neurological disorders causing marked weakness or gait impairment, and weight over 260 pounds, so results do not apply to those groups.

One author has a financial interest in the prosthetic system described. He signed a conflict-of-interest management agreement with the University of Pennsylvania Provost for Research. The article is listed as NIH extramural research support.

Do not conclude the IFIT prosthesis is proven superior to conventional prostheses. It was a two-week study of 22 participants compared with their own devices, gait parameters did not differ, and an author has a financial interest in the device.