OPTY-LINE remote-controlled adjustable intramedullary device implantation in open-wedge high tibial osteotomy: A prospective proof-of-concept pilot and comparison with Tomofix fixed-plate device method.

This initial, non-randomized, comparative evaluation of the OPTY-LINE device for HTO has produced similar outcomes to patients treated with the established Tomofix device. In particular, the rate of post-surgical bone regeneration and surgical accuracy achieved with the OPTY-LINE device are encouraging. Large-scale randomized controlled studies with longer follow-up are indicated to further evaluate the clinical and patient-related outcome performance for OPTY-LINE.