Longer term outcomes following high tibial osteotomy for osteoarthritis: a prospective, multi-centre observational study comparing Tomofix and OPTY-LINE devices

Purpose: Assessing surgical accuracy and patient-recorded outcome measures for patients fitted with either the OPTY-LINE intramedullary realignment system or the Tomofix plate for medial opening wedge high tibial osteotomy (HTO). Patients and methods: Two matched case series of patients with symptomatic medial compartment osteoarthritis without other significant knee pathology. One group comprised of 19 patients receiving the Tomofix plate, whereas another comprised of 12 patients receiving the OPTY-LINE intramedullary nail. Patella-centred long leg alignment radiographs were assessed to calculate surgical accuracy in all cases. Patients completed knee injury osteoarthritis outcome scores (KOOS) and osteotomy surgery patient satisfaction questionnaires pre-operatively and at 24 months post-surgery. Results: Absolute surgical accuracy at 2 years post-surgery was a mean 4.2 [standard deviation 3.7] for OPTY-LINE versus 9.2 [SD 7.8] for Tomofix (p = 0.11, Mann–Whitney U test). On average, patients in either the OPTY-LINE or Tomofix cohort reported at least a minimal perceptible clinical improvement—minimum average improvement of 15—for all five KOOS themes. No significant difference in change of KOOS scores over time or patient satisfaction levels were observed between the two cohorts. Conclusion: The OPTY-LINE device for HTO performs to a similar level as the Tomofix device. Surgical accuracy data are promising for OPTY-LINE, but does not seem to readily translate into difference in patient-reported outcomes compared to Tomofix. Even longer follow-up periods, to measure survival rates, and true randomised trials on larger samples can elucidate if there is a benefit for using one device over the other.