The objective was to evaluate the clinical and patient-related short- to medium-term performance of the OPTY-LINE nail device for high tibial osteotomy (HTO), comparing a case series of the said device to the established Tomofix fixed-plate device.
Males with symptomatic medial compartmental osteoarthritis and no serious (co-morbid) knee pathology were followed up, five Tomofix and six OPTY-LINE patients. Patients underwent computed tomography assessment and completed Knee Injury and Osteoarthritis Outcome score (KOOS) and osteotomy surgery patient satisfaction questionnaires, 3 and 6 months post-surgery. A radiologist impression score and a quantitative digital bone density analysis were performed by two independent radiologists. Mann-Whitney 
At 6 months post-surgery, for Tomofix, the median radiologists' healing impression score was 'progressive healing' versus 'union virtually complete' for the OPTY-LINE nail; bone healing quotient was 1.30 (standard deviation (SD) 1.74) versus 1.78 (SD 1.58), 
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.