Page 272 - Handbook of Biomechatronics
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266 Georgios A. Bertos and Evangelos G. Papadopoulos
Fig. 18 The first extremity osseointegration patient who was operated in 1990. The
patient can stand up and walk with crutches (A). At that time, the implants were of mod-
ular design with a distal collar (B and C). (D) The basic implant design of the OPRA
implant system. Three major components, the fixture, the abutment, and the abutment
screw are used. (From Li, Y., Branemark, R., 2017. Osseointegrated prostheses for rehabil-
itation following amputation: the pioneering Swedish model. Unfallchirurg, 120(4),
285–292. https://doi.org/10.1007/s00113-017-0331-4.)
Integrum, the company that is commercializing the osseointegration
technology OPRA, was given humanitarian approval from the FDA to per-
form 18 clinical trials (Li, 2016) for lower-limb amputees in the United
States, in 2015.
A metadata analysis (Hagberg et al., 2014) has shown that the risk of
superficial infections is acceptable, and can be treated with the use of oral
antibiotics. Results of the first 18 patients following the OPRA protocol
were promising, with a 94% success rate at the 2-year follow-up and good
quality of life (Hagberg et al., 2008).
“Endosteal bone resorption could be an alarming radiological sign
regarding the fixation and future survival of the fixture especially when